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Meta-Analysis
. 2010 Apr 14;2010(4):CD005533.
doi: 10.1002/14651858.CD005533.pub2.

Addition of long-acting beta2-agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma

Francine M Ducharme  1 , Muireann Ni Chroinin, Ilana Greenstone, Toby J Lasserson
Affiliations
Meta-Analysis

Addition of long-acting beta2-agonists to inhaled steroids versus higher dose inhaled steroids in adults and children with persistent asthma

Francine M Ducharme et al. Cochrane Database Syst Rev. .

Abstract

Background: In asthmatic patients inadequately controlled on inhaled corticosteroids and/or those with moderate persistent asthma, two main options are recommended: the combination of a long-acting inhaled ss2 agonist (LABA) with inhaled corticosteroids (ICS) or use of a higher dose of inhaled corticosteroids.

Objectives: To determine the effect of the combination of long-acting ss(2) agonists and inhaled corticosteroids compared to a higher dose of inhaled corticosteroids on the risk of asthma exacerbations, pulmonary function and on other measures of asthma control, and to look for characteristics associated with greater benefit for either treatment option.

Search strategy: We identified randomised controlled trials (RCTs) through electronic database searches (MEDLINE, EMBASE and CINAHL), bibliographies of RCTs, clinical trial registries and correspondence with manufacturers until May 2008.

Selection criteria: RCTs that compared the combination of inhaled LABA and ICS to a higher dose of inhaled corticosteroids, in children and adults with asthma.

Data collection and analysis: Two authors independently assessed methodological quality and extracted data. We obtained confirmation from the trialists when possible. The primary endpoint was the number of patients experiencing one or more asthma exacerbations requiring oral corticosteroids.

Main results: This review included 48 studies (15,155 participants including 1155 children and 14,000 adults). Participants were inadequately controlled on their current ICS regimen, experiencing ongoing symptoms and with generally moderate (FEV1 60% to 79% of predicted) airway obstruction. The studies tested the combination of salmeterol or formoterol with a median dose of 400 mcg/day of beclomethasone or equivalent (BDP-eq) compared to a median of 1000 mcg/day of BDP-eq, usually for 24 weeks or less. There was a statistically significantly lower risk of exacerbations requiring systemic corticosteroids in patients treated with LABA and ICS (RR 0.88, 95% CI 0.78 to 0.98, 27 studies, N = 10,578) from 11.45% to 10%, with a number needed to treat of 73 (median study duration: 12 weeks). The study results were dominated by adult studies; trial data from three paediatric studies showed a trend towards increased risk of rescue oral steroids (RR 1.24, 95% CI 0.58 to 2.66) and hospital admission (RR 2.21, 95% CI 0.74 to 6.64) associated with combination therapy. Overall, there was no statistically significant difference in the risk ratios for either hospital admission (RR 1.02, 95% CI 0.67 to 1.56) or serious adverse events (RR 1.12, 95% CI 0.91 to 1.37). The combination of LABA and ICS resulted in significantly greater but modest improvement from baseline in lung function, symptoms and rescue medication use than with higher ICS dose. Despite no significant group difference in the risk of overall adverse events (RR 0.99, 95% CI 0.95 to 1.03), there was an increase in the risk of tremor (RR 1.84, 95% CI 1.20 to 2.82) and a lower risk of oral thrush (RR 0.58, 95% CI 0.40 to 0.86)) in the LABA and ICS compared to the higher ICS group. There was no significant difference in hoarseness or headache between the treatment groups. The rate of withdrawals due to poor asthma control favoured the combination of LABA and ICS (RR 0.65, 95% CI 0.51 to 0.83).

Authors' conclusions: In adolescents and adults with sub-optimal control on low dose ICS monotherapy, the combination of LABA and ICS is modestly more effective in reducing the risk of exacerbations requiring oral corticosteroids than a higher dose of ICS. Combination therapy also led to modestly greater improvement in lung function, symptoms and use of rescue ss(2) agonists and to fewer withdrawals due to poor asthma control than with a higher dose of inhaled corticosteroids. Apart from an increased rate of tremor and less oral candidiasis with combination therapy, the two options appear relatively safe in adults although adverse effects associated with long-term ICS treatment were seldom monitored. In children, combination therapy did not lead to a significant reduction, but rather a trend towards an increased risk, of oral steroid-treated exacerbations and hospital admissions. These trends raised concern about the safety of combination therapy in view of modest improvement in children under the age of 12 years.

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Conflict of interest statement

In the past five years, Francine Ducharme received some research funding from Glaxo Wellcome and Merck and gave CME conferences supported by Merck Frost. No conflict of interest reported by Muireann Ni Chroinin, Ilana Greenstone, Toby Lasserson, A Danish, H Magdalinos, V Masse and M Julien.

Figures

1
1
Literature flow diagram for June 2008 update of the review.
2
2
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
3
3
Forest plot of comparison: 1 LABA + ICS versus higher dose ICS, outcome: 1.1 # patients with exacerbations requiring oral steroids.
4
4
Funnel plot of comparison: 1 LABA + ICS versus higher dose ICS, outcome: 1.1 # patients with exacerbations requiring oral steroids.
5
5
Forest plot of comparison: 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), outcome: 2.4 # patients requiring oral steroids: children versus adults.
1.1
1.1. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 1 # patients with exacerbations requiring oral steroids.
1.2
1.2. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 2 # patients with exacerbations requiring hospitalisation.
1.3
1.3. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 3 # withdrawals due to poor asthma control or exacerbation.
1.4
1.4. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 4 Total # withdrawals.
1.5
1.5. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 5 # withdrawals due to adverse events.
1.6
1.6. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 6 FEV1 at endpoint.
1.7
1.7. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 7 FEV1 (predicted) at endpoint.
1.8
1.8. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 8 Change in FEV1 at endpoint.
1.9
1.9. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 9 Change in FEV1 stratifying on treatment period.
1.10
1.10. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 10 Change in FEV1 (predicted) at endpoint.
1.11
1.11. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 11 Morning PEF at endpoint.
1.12
1.12. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 12 Change in morning or clinic PEF at endpoint.
1.13
1.13. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 13 Morning PEF (% predicted) at endpoint.
1.14
1.14. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 14 Evening PEF at endpoint.
1.16
1.16. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 16 Change in evening PEF at endpoint.
1.18
1.18. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 18 PEF variability at endpoint.
1.19
1.19. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 19 Change in PEF variability at endpoint.
1.20
1.20. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 20 Change in daytime symptom score at endpoint.
1.21
1.21. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 21 Change in overall (24 hrs) symptom score at endpoint.
1.22
1.22. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 22 Change in % symptom‐free days at endpoint.
1.23
1.23. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 23 % symptom‐free days at endpoint.
1.24
1.24. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 24 Daytime symptom score at endpoint.
1.25
1.25. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 25 Nighttime symptom score at endpoint.
1.26
1.26. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 26 Change in nighttime symptom score at endpoint.
1.27
1.27. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 27 % symptom‐free nights at endpoint.
1.28
1.28. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 28 Change in night time awakenings ( number of nights) at endpoint.
1.29
1.29. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 29 % nighttime awakenings at endpoint.
1.30
1.30. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 30 % nights with no awakenings at endpoint.
1.31
1.31. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 31 Change in % nights with no awakenings at endpoint.
1.32
1.32. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 32 Change in # daytime rescue inhalations at endpoint.
1.33
1.33. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 33 Change in # nighttime rescue inhalations at endpoint.
1.34
1.34. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 34 Absolute (or %) change in # rescue inhalations (per 24 hrs) at endpoint.
1.35
1.35. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 35 # daytime rescue inhalations (puffs/day) at endpoint.
1.36
1.36. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 36 # nighttime rescue inhalations at endpoint (puffs/day).
1.37
1.37. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 37 % overall rescue‐free days at endpoint.
1.38
1.38. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 38 Change in % symptom‐free days at endpoint.
1.39
1.39. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 39 Change in mean % rescue‐free days at endpoint.
1.40
1.40. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 40 Change in asthma control days at endpoint (%).
1.41
1.41. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 41 Change in quality of life (AQLQ score) at endpoint.
1.42
1.42. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 42 Change in Hyland QOL at endpoint.
1.43
1.43. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 43 # Achieving good asthma control.
1.44
1.44. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 44 % asthma control days at endpoint.
1.45
1.45. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 45 Serum ECP( microg /L).
1.46
1.46. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 46 Plasma cortisol ( nmol/L) 8am at 8 weeks.
1.47
1.47. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 47 Tidal exhaled NO(ppb).
1.48
1.48. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 48 PD20 @ 8 weeks.
1.49
1.49. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 49 PC20.
1.50
1.50. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 50 Change in mean urine Cortisol/Creatinine ratio.
1.52
1.52. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 52 Serious adverse events.
1.53
1.53. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 53 # patients with tremor.
1.54
1.54. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 54 # patients with oral thrush.
1.55
1.55. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 55 Total # adverse events.
1.56
1.56. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 56 # patients with adverse cardiovascular events.
1.57
1.57. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 57 # patients with headache.
1.58
1.58. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 58 # patients with hoarseness.
1.59
1.59. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 59 # patients with tachycardia or palpitations.
1.60
1.60. Analysis
Comparison 1 LABA + ICS versus higher dose ICS, Outcome 60 Growth (paediatric data).
2.1
2.1. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 1 # patients with exacerbations requiring oral steroids: children versus adults.
2.2
2.2. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 2 # patients with exacerbations requiring oral steroids: ICS dose associated with LABA.
2.3
2.3. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 3 # patients with exacerbations requiring oral steroids: ICS dose difference between LABA and higher ICS groups.
2.4
2.4. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 4 # patients with exacerbations requiring oral steroids: formoterol versus salmeterol.
2.5
2.5. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 5 # patients with exacerbations requiring oral steroids: 1 versus 2 devices to deliver LABA + ICS.
2.6
2.6. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 6 # patients with exacerbations requiring oral steroids: duration of trial.
2.7
2.7. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 7 # patients with exacerbations requiring oral steroids: publication status of data.
2.8
2.8. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 8 # patients with exacerbations requiring oral steroids: funding status.
2.9
2.9. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 9 # patients with exacerbations requiring oral steroids: sensitivity analysis by allocation sequence generation.
2.10
2.10. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 10 # patients with exacerbations requiring oral steroids: sensitivity analysis by allocation concealment.
2.11
2.11. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 11 # patients with exacerbations requiring oral steroids: sensitivity analysis by blinding.
2.12
2.12. Analysis
Comparison 2 LABA + ICS versus higher dose ICS (subgroup and sensitivity analyses), Outcome 12 # patients with exacerbations requiring hospitalisation: children versus adults.
3.1
3.1. Analysis
Comparison 3 WMD archive, Outcome 1 FEV1 (L) at endpoint.
3.2
3.2. Analysis
Comparison 3 WMD archive, Outcome 2 FEV1 (% predicted) at endpoint.
3.3
3.3. Analysis
Comparison 3 WMD archive, Outcome 3 Change in FEV1 (L) at endpoint.
3.4
3.4. Analysis
Comparison 3 WMD archive, Outcome 4 Change in FEV1 (L) stratifying on treatment period.
3.5
3.5. Analysis
Comparison 3 WMD archive, Outcome 5 Morning PEF (L/min) at endpoint.
3.6
3.6. Analysis
Comparison 3 WMD archive, Outcome 6 Evening PEF (L/min) at endpoint.
3.7
3.7. Analysis
Comparison 3 WMD archive, Outcome 7 Change in morning or clinic PEF (L/min) at endpoint.
3.8
3.8. Analysis
Comparison 3 WMD archive, Outcome 8 Change in evening PEF (L/min) at endpoint.
3.9
3.9. Analysis
Comparison 3 WMD archive, Outcome 9 Change in FEV1 (% predicted) at endpoint.
3.10
3.10. Analysis
Comparison 3 WMD archive, Outcome 10 Change in % symptom‐free days at endpoint.
3.11
3.11. Analysis
Comparison 3 WMD archive, Outcome 11 # patients with exacerbations requiring oral steroids.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Jenkins 2000 {published and unpublished data}
    1. Becker I, Kielborn A, Price MJ, Volmer T, Lloyd AC. Cost‐effectiveness of salmeterol/fluticasone combination product and budesonide in asthma patients in Germany. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999:854.
    1. Glaxo Smith Kline (SAS40006). A randomised, double‐blind, double‐dummy, parallel group comparison of Seretide Diskus/Accuhaler (50/250µg strength) b.i.d. with budesonide 800µg b.i.d. in adolescents and adults with reversible airways obstruction. http://www.clinicalstudyresults.org 2005.
    1. Jenkins C, Woolcock A James M. Superior overall control of moderate to severe asthma with salmeterol/fluticasone propionate (FP) combination (50/250 mcg bd) compared with three‐fold‐higher dose of budesonide (800mcg bd). European Respiratory Journal. 2000; Vol. 16, issue Suppl 31:456s.
    1. Jenkins C, Woolcock AJ, Saarelainen P, Lundbaack B James MH. Salmeterol/fluticasone propionate combination therapy 50/250mcgs twice daily is more effective than budesonide 800 twice daily in treating moderate to severe asthma. Respiratory Medicine 2000;94(7):715‐23. - PubMed
    1. Lundback B, Jenkins C, Price MJ, Thwaites RM. Cost‐effectiveness of salmeterol/fluticasone propionate combination product 50/250 microg twice daily and budesonide 800 microg twice daily in the treatment of adults and adolescents with asthma. Respiratory Medicine 2000;94(7):724‐32. - PubMed
Johansson 2001 {published and unpublished data}
    1. Glaxo Smith Kline (SAS40007). A randomised, double‐blind, double‐dummy, parallel‐group comparison of Seretide Diskus/Accuhaler (50/100µg strength) twice daily (bid) with budesonide 400µg bid in adolescents and adults with reversible airways obstruction. http://www.clinicalstudyresults.org 2005.
    1. Johansson G, McIvor RA, D'Ambrosio FP, Gratziou C, James MH. Comparison of salmeterol/fluticasone propionate combination with budesonide in patients with mild‐to‐moderate asthma. Clinical Drug Investigation 2001;21(9):633‐42.
Joshi 2005 {published data only}
    1. Joshi J, Jagannath K, Chabbra S, Rajan S, Gogtay J, Po CJ, et al. Salmeterol/fluticasone combination product (SFC) provides better asthma control compared to high dose fluticasone (FP) in symptomatic patients with asthma. European Respiratory Journal 2005;26(Suppl 49):Abstract No. 2771.
Kelsen 1999 {published and unpublished data}
    1. Glaxo Smith Kline (SLGA5017). A comparison of adding Serevent versus doubling the dose of Beclovent in asthmatic subjects symptomatic on their existing inhaled corticosteroids. http//:ctr.gsk.co.uk 2006.
    1. Kelsen SG, Church NL, Gillman SA, Lanier BQ, Emmett AH, Rickard KA, et al. Salmeterol added to inhaled corticosteroids therapy is superior to doubling the dose of inhaled corticosteroids: a randomized clinical trial. Journal of Asthma 1999;36(8):703‐15. - PubMed
Kips 2000 {published data only}
    1. Kips JC, O'Connor BJ, Inman MD, Svenson K, Pauwels RA, O'Byrne PM. A long‐term study of the antiinflammatory effect of low‐dose budesonide plus formoterol versus high‐dose budesonide in asthma. American Journal of Respiratory and Critical Care Medicine 2000;161:996‐1001. - PubMed
Lalloo 2003 {published and unpublished data}
    1. Lalloo UG, Bantje TA, Kozma D, Krofta K, Ankerst J, Johansen B, et al. Low‐dose Symbicort (budesonide/formoterol) is more effective than double‐dose inhaled corticosteroid in mild asthma. Allergy Clinical Immunology International 2000; Vol. Suppl 2, issue 122.
    1. Lalloo UG, Malolepsky J, Kozma D, Krofta K, Ankerst J, Johansen B, et al. Budesonide and formoterol in a single inhaler controls exacerbations more effectively than a higher dose of inhaled corticosteroids alone, in mild‐moderate persistent asthma. European Respiratory Journal 2001;18(Suppl 33):43s.
    1. Lalloo UG, Malolepszy D, Kozma K, Krofta J, Ankerst B, Johanasen NC, et al. Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild to moderate asthma. Chest 2003;123(5):1480‐7. - PubMed
    1. Lalloo UG, Malolepszy J, Kozma D, Krofta K, Ankerst J, Johansen B, Thomson NC. Symbicort® (budesonide and formoterol in a single inhaler) is more effective than increasing the dose of inhaled corticosteroids in mild asthma. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
    1. Lalloo UG, Malolepszy J, Kozma D, Krofta K, Ankerst J, Johansen B, et al. Budesonide and formoterol in a single inhaler is more effective than a higher dose of inhaled corticosteroid in mild‐moderate persistent asthma. European Respiratory Journal 2001;18(Suppl 33):159s.
Li 1999 {published data only}
    1. Li X, Ward C, Thien F, Bish R, Bamford T, Bao X, Bailey M, Wilson JW, et al. An antiinflammatory effect of salmeterol, a long‐acting B2‐agonist, assessed in airway biopsies and bronchoalveolar lavage in asthma. American Journal of Respiratory and Critical Care Medicine 1999;160(5):1493‐9. - PubMed
    1. Reid DW, Ward C, Wang, N, Zheng L, Bish R, Orsida B, Walters EH. Possible anti‐inflammatory effect of salmeterol against interleukin‐8 and neutrophil activation in asthma in vivo. European Respiratory Journal 2003;21(6):994‐9. - PubMed
LOCCS {published data only}
    1. American Lung Association Asthma Clinical Research. Randomized comparison of strategies for reducing treatment in mild persistent asthma. New England Journal of Medicine 2007;356(20):2027‐39. - PubMed
Mitchell 2003 {published data only}
    1. Mitchell C, Jenkins C, Scicchitano R, Rubinfeld A, Kottakis J. Formoterol (Foradil) and medium‐high doses of inhaled corticosteroids are more effective than high doses of corticosteroids in moderate‐to‐severe asthma. Pulmonary Pharmacology & Therapeutics 2003;16(5):299‐306. - PubMed
    1. Mitchell C, Jenkins C, Scicchitano R, Rubinfield A. Adding formoterol is more effective and safer than doubling the dose of inhaled steroids in moderately severe asthmatics. Respiratory and Critical Care Medicine 2000;161(3):A197.
Murray 1999 {published and unpublished data}
    1. Glaxo Smith Kline (SLGA5018). A comparison of adding Serevent® versus doubling the dose of Beclovent® in asthmatic subjects symptomatic on their existing inhaled corticosteroids. http:www.ctr.gsk.co.uk 2006.
    1. Murray JJ, Church NL, Anderson WH, Bernstein DI, Wenzel SE, Emmett A, et al. Concurrent use of salmeterol with inhaled corticosteroids is more effective than inhaled corticosteroid dose increases. Allergy and Asthma Proceedings 1999;20(3):173‐80. - PubMed
O'Byrne 2001 {published data only}
    1. AstraZeneca. Unpublished data (personal communication). 2008.
    1. Barnes PJ, O'Byrne PM, Rodriguez‐Roisin R, Runnerstrom E, Sandstrom T, Svensson K, et al. Oxis and Pulmicort turbuhaler in the management of asthma OPTIMA international study group. Treatment of mild persistent asthma with low doses of inhaled budesonide alone or in combination with formoterol. Thorax 2000;55(Suppl 3):A4.
    1. Barnes PJ, O'Byrne PM, Rodriguez‐Roisin R, Runnerstrom E, Sandstrom T, Svensson K, et al. Treatment of mild persistent asthma with low doses of inhaled budesonide alone or in combination with formoterol. For the Oxis and Pulmicort Turbuhaler in the Management of Asthma (OPTIMA) international study group. Thorax 2000; Vol. 55, issue Suppl 3:s5.
    1. Grosser D, Smith B. Low‐dose budesonide improved asthma control in mild asthma; adding formoterol improved control in corticosteroid‐treated patients. ACP Journal Club 2002;137(1):19. - PubMed
    1. Jönsson BG, Berggren FE, Svensson K, O'Byrne PM. Budesonide and formoterol in mild persistent asthma compared with doubling the dose of budesonide ‐ a cost‐effectiveness analysis. European Respiratory Journal. 2001; Vol. 18, issue Suppl 33:517s.
O'Byrne 2005 {published and unpublished data}
    1. Bruce SA, Scherer YK. Maintenance and symptom relief with budesonide plus formoterol reduced severe asthma exacerbations. Evidence‐Based Nursing 2005;8(3):78. - PubMed
    1. Jönsson BG, Berggren FE, Svensson K, O'Byrne PM. Budesonide and formoterol in mild persistent asthma compared with doubling the dose of budesonide ‐ a cost‐effectiveness analysis. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:517s.
    1. Jönsson BG, Berggren FE, Svensson K, O'Byrne PM. Economic results of adding formoterol to budesonide in mild persistent asthma. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:331s.
    1. O'Byrne PM, Bisgaard H, Godard PP, Pistolesi M, Palmqvist M, Zhu Y, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. American Journal of Respiratory & Critical Care Medicine 2005;171(2):129‐36. - PubMed
    1. SD‐039‐673. Efficacy and safety of budesonide/formoterol (Symbicort) Turbuhaler® as single therapy in patients with mild‐moderate asthma. Comparison with Symbicort Turbuhaler and Pulmicort® Turbuhaler as maintenance therapy, both complemented with Bricanyl® Turbuhaler (STAY). http://www.astrazenecaclinicaltrials.com 2006.
Ortega‐Cisneros 1998 {published data only}
    1. Ortega‐Cisnero M, Maldonado‐Alaniz ML, Rosas Vargas MA, Sierra‐Monge JJL. Salmeterol and inhaled beclomethasone versus high dose inhaled beclomethasone in the control of pediatric patients with moderate asthma. Annals of Allergy, Asthma, and Immunology 1998; Vol. 80:131.
Pauwels 1997 {published data only}
    1. AstraZeneca. Unpublished data (personal communication). 2008.
    1. Pauwels R. Additive effects of inhaled formoterol and budesonide in reducing asthma exacerbations. Allergy 1998;53:20‐3. - PubMed
    1. Pauwels RA, Lofdahl CG, Postma DA, Tattersfield AE, O'Byrne P, Barnes PJ, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. New England Journal of Medicine 1997;337(20):1405‐11. - PubMed
Pearlman 1999 {published data only}
    1. FLTA3015. A randomized, double‐blind, placebo‐controlled, parallel‐group pilot trial evaluating safety and efficacy of salmeterol xinafoate and fluticasone propionate individually and in combination in subjects with asthma. www.ctr.gsk.co.uk 2005 (accessed 9 June 2008).
    1. Pearlman DS, Stricker W, Weistein S, Gross G, Chervinsky P, Woodring A, et al. Inhaled salmeterol and fluticasone: a study comparing monotherapy and combination therapy in asthma. Annals of Allergy, Asthma, and Immunology 1999;82:257‐65. - PubMed
SAM104926 {published data only}
    1. Glaxo Smith Kline (SAM104926). A multicentre, randomised, double‐blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS) for 12 weeks in asthma in children aged 4‐11 years not controlled by inhaled corticosteroids alone at medium dose. http://ctr.gsk.co.uk 2007 (accessed 14 January 2008).
SAM30013 {unpublished data only}
    1. Boulet LP, Chapman K, Roberts J, Watson EG. Efficacy of salmeterol/fluticasone propionate HFA MDI versus high dose fluticasone propionate HFA MDI in adolescent and adult asthma. Poster European Respiratory Society Meeting 2003.
    1. Glaxo Smith Kline (SAM30013). A 12 week, randomized, double‐blind, parallel group study to compare the efficacy and safety of salmeterol/fluticasone propionate/GR106642X (25/50 µg x 2 inhalations) bid with fluticasone propionate (125 µg x 2 inhalations) bid in adolescent and adult patients with mild to moderate asthma. http://www.ctr.gsk.co.uk 2005.
SAM30022 {unpublished data only}
    1. Glaxo Smith Kline (SAM30022). A phase IV, multi‐centre, double‐blind, double‐dummy, parallel group, randomised study comparing Seretide (25/50 2 puffs bd) via the Evohaler (MDI‐HFA) with Beclometasone dipropionate (200mcg 2 puffs bd) via the MDI‐CFC in adolescents and adults experiencing moderate symptoms of reversible airways obstruction. http://www.ctr.gsk.co.uk 2005.
SAM40012 {unpublished data only}
    1. Dorinsky P, Emmett A, Sutton L. Reduced risk for asthma exacerbations in pediatric patients receiving salmeterol plus inhaled corticosteroids (ICS) vs ICS alone [Abstract]. European Respiratory Journal 2004;24(Suppl 48):308s.
    1. Glasxo Smith Kline (SAM40012). A multicentre, randomised, double‐blind, double‐dummy, parallel group comparison of three treatments: 1) salmeterol/fluticasone propionate (SFC) (50/100mcg strength) bd via DISKUS/ACCUHALER inhaler, 2) fluticasone propionate 200mcg bd via DISKUS/ACCUHALER inhaler, 3) fluticasone propionate 100mcg bd via DISKUS/ACCUHALER inhaler in children aged 4‐11 years with asthma. http://www.ctr.gsk.co.uk 2005 (accessed 30 April 2008).
SAM40090 {unpublished data only}
    1. Glaxo Smith Kline (SAM40090). A twelve week multi‐centre, randomised, double‐blind, parallel group, comparative trial of Advair 50/100 mcg Diskus inhalation device BID versus Flovent 250 mcg Diskus inhalation device BID in adolescents and adults with persistent asthma (Program of Advair Control and Effectiveness – Advair Low Dose [PACE‐ALD]). http://www.ctr.gsk.co.uk 2005.
SAM40100 {unpublished data only}
    1. Glaxo Smith Kline (SAM40100). Randomised, double‐blind, comparator study to demonstrate the superiority of salmeterol/fluticasone propionate combination DISKUS™ 50/100mcg bd over fluticasone propionate DISKUS™/ACCUHALER™ 200mcg bd with respect to airway physiology in asthmatic children treated for 6 weeks. http://ctr.gsk.co.uk 2006 (accessed 4 January 2008).
SAM40120 {unpublished data only}
    1. Glaxo Smith Kline (SAM40120). A phase IV, multi‐centre, double‐blind, parallel group, randomised study comparing Seretide (50/100mcg bd) via the Evohaler (MDI‐HFA) with Flixotide (250mcg bd) via the Evohaler (MDI‐HFA) in asthmatics with significant smoking history. http://www.ctr.gsk.co.uk 2005.
SAS40013 {unpublished data only}
    1. Galxo Smith Kline (SAS40013). Can the serum level of eosinophil cationic protein (ECP) give directions for the choice between increasing the dose of fluticasone propionate or the addition of salmeterol in patients with symptomatic asthma?. http://www.ctr.gsk.co.uk 2005.
SAS40026 {published and unpublished data}
    1. Bloom J, Calhoun W, König S, Yancey S, Reilly D, Edwards L, et al. Fluticasone propionate/salmeterol 100/50mcg is inhaled steroid sparing in patients who required fluticasone propionate 250mcg for asthma stability. American Thoracic Society 99th International Conference. 2003; Vol. D034:Poster C33.
    1. Dorinsky P, Yancey S, Reilly D, Stauffer J, Edwards L, Sutton L. Control of airway inflammation is maintained in asthma patients following a reduction in ICS dose with fluticasone propionate/salmeterol (FSC) compared with higher dose fluticasone propionate (FP) alone. European Respiratory Journal 2004;24(Suppl 48):308s.
    1. Glaxo Smith Kline (SAS40026). A randomized, double‐blind, parallel group, comparative trial of fluticasone propionate/salmeterol combination product 100/50mcg DISKUS† inhaler BID versus fluticasone propionate 250mcg DISKUS inhaler BID in adolescents and adults with moderate persistent asthma . http://ctr.gsk.co.uk 2006.
    1. Jarjour NN, Wilson SJ, Koenig SM, Laviolette M, Moore WC, Davis WB, et al. Control of airway inflammation maintained at a lower steroid dose with 100/50 microg of fluticasone propionate/salmeterol. Journal of Allergy and Clinical Immunology 2006;118(1):44‐52. - PubMed
    1. Stauffer J, Yancey S, Waitkus‐Edwards K, Edwards L, Dorinsky P. Clinical markers of worsening asthma with the fluticasone/salmeterol 100/50mcg Diskus FSC vs fluticasone propionate (FP) 250mcg alone in patients requiring FP 250mcg BID for asthma stability. Annals of Allergy, Asthma and Immunology 2004;92(1):144.
SD 039 0726 {unpublished data only}
    1. AstraZeneca (SD 039 0726). A twelve‐week, randomized, double‐blind, double‐dummy, placebo‐ and active‐controlled study of SYMBICORT® pMDI administered once daily in adults and adolescents with asthma. www.astrazenecaclinicaltrials.com 2005 (accessed 30 April 2008).
    1. Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte WS. Asthma control with once‐daily budesonide/formoterol (BUD/FM) pressurized metered‐dose inhaler. http://www.abstracts2view.com/ats07 2007 (accessed 30 April 2008).
SD 039 0728 {unpublished data only}
    1. AstraZeneca (SD 039 0728). A 52‐week, randomized, double‐blind, single‐dummy, parallel‐group,multicenter Phase III study comparing the long‐term safety of SYMBICORT® pMDI 160/4.5 μg x 4 actuations twice daily to SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily and budesonide HFA pMDI 160 μg x 4 actuations twice daily in adult and adolescent subjects with asthma. www.astrazenecaclinicaltrials.com 2006 (accessed 30 April 2008).
    1. O'Brien CD, Peters SP, Prenner BM, Martin P. Resource use with budesonide/formoterol pressurized metered‐dose inhaler (BUD/FM pMDI) versus BUD pMDI in asthma patients. http://www.abstracts2view.com/ats07 2007 (accessed 30 April 2008).
    1. Peters SP, Prenner BM, Martin P, O'Brien CD. Long‐term effects on lung function of budesonide (BUD) and formoterol (FM) in one pressurized metered‐dose inhaler (BUD/FM pMDI) and BUD pMDI in patients with asthma. http://www.abstracts2view.com/ats07 2007 (accessed 30 April 2008).
    1. Prenner BM, Peters SP, Martin P, O'Brien CD. Long‐term control of asthma symptoms with budesonide/formoterol pressurized metered‐dose inhaler (BUD/FM pMDI) versus BUD pMDI. http://www.abstracts2view.com/ats07 2007 (accessed 30 April 2008).
    1. Prenner BM, Peters SP, Martin P, O'Brien CD. Safety pharmacodynamics (PD) of budesonide/formoterol (BUD/FM) pMDI in asthma patients. http://www.abstracts2view.com/ats07 2007 (accessed 30 April 2008).
SFCF4026 {unpublished data only}
    1. Glaxo Smith Kline (SFCF4026). Maintenance of asthma control in adults: comparison of three therapeutic strategies in patients whose asthma is controlled by a medium dose of inhaled corticosteroid and a long‐acting inhaled beta2‐agonist. http://www.ctr.gsk.co.uk 2005.
SLGA5021 {unpublished data only}
    1. Glaxo Smith Kline (SLGA5021). A randomized, double‐blind clinical trial comparing the efficacy and safety of salmeterol xinafoate 42mcg b.i.d.* plus fluticasone propionate 88mcg b.i.d.* versus fluticasone propionate 220mcg b.i.d.* alone in subjects with asthma not well controlled on fluticasone propionate 88mcg b.i.d.* (*Doses quoted are ex‐actuator: equivalent ex‐valve doses are 50mcg, 100mcg and 250mcg, respectively). http://www.ctr.gsk.co.uk 2005.
    1. Kalberg CJ, Nelson H, Yancey S, Petrocella V, Emmett AH, Rickard KA, et al. A comparison of added salmeterol versus increased‐dose fluticasone in patients symptomatic on low‐dose fluticasone [abstract]. Journal of Allergy and Clinical Immunology 1998;101( Suppl):6s.
    1. Knobil K, Kalberg C, Emmett A, Rickard K. Adding salmeterol is more effective than increasing the dose of fluticasone for patients with asthma who are symptomatic on low dose fluticasone. European Respiratory Journal 1998;12(supp 29):19s P160.
    1. Matz J, Emmett A, Rickard K, Kalberg C. Addition of salmeterol to low‐dose fluticasone versus higher‐dose fluticasone: an analysis of asthma exacerbations. Journal of Allergy and Clinical Immunology 2001;107(5):783‐9. - PubMed
Van Noord 1999 {published data only}
    1. Schreurs AJ, Noord JA, Mulder PG. Fluticasone propionate and salmeterol xinafoate in patients with mild to moderate asthma. European Respiratory Journal 1998; Vol. 12 (Suppl 29), issue 19s:P159.
    1. Noord JA, Schreurs AJM, Mol SJM, Mulder PGH. Addition of salmeterol versus doubling the dose of fluticasone propionate in patients with mild to moderate asthma. Thorax 1999;54:207‐12. - PMC - PubMed
Verberne 1998 {published and unpublished data}
    1. Glaxo Smith Kline (SLGB4014 (SLPT15)). Placebo controlled study during one year comparing the addition of salmeterol with an increase of the dose of the inhaled corticosteroid in asthmatic children already on treatment with inhaled corticosteroids. http://ctr.gsk.co.uk 2006.
    1. Verberne AAPH, Frost C, Duiverman EJ, Grol MH, Kerribijn KF. Addition of salmeterol versus doubling the dose of beclomethasone in children with asthma. American Journal of Respiratory and Critical Care Medicine 1998;158:213‐19. - PubMed
Vermetten 1999 {published data only}
    1. Glaxo Smith Kline (SMS40180/SLM9021B). A 12 week study to compare the efficacy and safety of salmeterol xinafoate plus beclomethasone dipropionate with a double dose of beclomethasone dipropionate in patients with mild to moderate reversible airways obstruction treated by a general practitioner . http://www.ctr.gsk.co.uk 2006.
    1. Vermetten AM, Boermans JM, Luiten WDVF, Mulder PGH, Vermue NA. Comparison of salmeterol with beclomethasone in adult patients with mild persistent asthma who are already on low‐dose inhaled steroids. Journal of Asthma 1999;36(1):97‐106. - PubMed
Wallin 2003 {published data only}
    1. Glaxo Smith Kline (SLGQ98). A 12 week randomized, double‐blind, parallel group study evaluating effect of fluticasone propionate 500mcgBID, fluticasone propionate 200mcg plus salmeterol 50mcg BID or fluticasone propionate 200mcg BID for control of airway inflammation in subjects with asthma, not controlled on inhaled corticosteroids. http://www.ctr.gsk.co.uk 2006.
    1. Sue‐Chu M, Wallin A, Wilson S, Ward J, Sandstrom T, Djukanovic R, et al. Bronchial biopsy study in asthmatics treated with low and high dose fluticasone propionate (FP) compared to low dose FP combined with salmeterol. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999.
    1. Wallin A, Sandstrom T, Cioppa GD, Holgate S, Wilson S. The effects of regular inhaled formoterol and budesonide on preformed Th‐2 cytokines in mild asthmatics. Respiratory Medicine 2002;96(12):121‐5. - PubMed
    1. Wallin A, Sue‐Chu M, Bjermer L, Ward J, Sanstrom T, Lindberg A, et al. Effect of inhaled fluticasone with and without salmeterol on airway inflammation in asthma. Journal of Allergy and Clinical Immunology 2003;112(1):72‐8. - PubMed
Woolcock 1996a {published and unpublished data}
    1. Glaxo Smith Kline (SMS30045). A multicentre, double‐blind, parallel group, randomised study comparing the efficacy and safety of inhaled salmeterol xinafoate 50 mg bd and beclomethasone dipropionate 500 mg bd with that of salmeterol xinafoate 100 mg bd and beclomethasone dipropionate 500 mg or beclomethasone dipropionate 1000 mg bd in patients with reversible airways obstruction. www.ctr.gsk.co.uk 2006.
    1. Woolcock A, Lunback B, Ringdal N, Jacques LA. Comparison of addition of salmeterol to inhaled steroids with doubling the dose of inhaled steroids. Amercian Journal of Respiratory and Critical Care Medicine 1996;153:1481‐8. - PubMed
Woolcock 1996b {published and unpublished data}
    1. Glaxo Smith Kline (SMS30045). A multicentre, double‐blind, parallel group, randomised study comparing the efficacy and safety of inhaled salmeterol xinafoate 50 mg bd and beclomethasone dipropionate 500 mg bd with that of salmeterol xinafoate 100 mg bd and beclomethasone dipropionate 500 mg or beclomethasone dipropionate 1000 mg bd in patients with reversible airways obstruction. www.ctr.gsk.co.uk 2006.
    1. Woolcock A, Lundback B, Ringdal N, Jacques LA. Comparison of addition of salmeterol to inhaled steroids with doubling the dose of inhaled steroids. American Journal for Respiratory and Critical Care Medicine 1996;153:1481‐8. - PubMed
Zhong 2005 {published and unpublished data}
    1. Glaxo Smith Kline (SAM40067). A multicentre, randomized, open‐label, parallel‐group, six‐week treatment study to evaluate the efficacy and safety of Seretide (salmeterol/fluticasone propionate combination product) 50/100 mg strength bd via Accuhaler™ inhaler vs Pulmicort Turbuhaler™ 400 mg bd in Chinese adults with asthma. http://ctr.gsk.co.uk 2006.
    1. Zhong NS, Zheng JP, Cai BQ, Xie CM, Sun TY, Wang DQ, et al. Evaluation of the clinical efficacy and the safety of salmeterol/fluticasone propionate accuhaler compared to budesonide turbuhaler in the control of adult asthma. Zhonghua Jie He He Hu Xi Za Zhi 2005;28(4):233‐7. - PubMed

References to studies excluded from this review

Aalbers 2004 {published data only}
    1. Aalbers R, Backer V, Kava TTK, Omenaas ER, Sandstrom T, Jorup C, et al. Adjustable maintenance dosing with budesonide/formoterol compared with fixed‐dose salmeterol/fluticasone in moderate to severe asthma. Current Medical Research & Opinion 2004;20(2):225‐40. - PubMed
    1. Aalbers R, Backer V, Kava TTK, Welte T, Omenaas ER, Bergqvist PBF, et al. Adjustable dosing with budesonide/formoterol reduces the rate of asthma exacerbations compared with fixed dosing salmeterol/fluticasone. European Respiratory Society. 2003:p2‐20.
    1. Aalbers R, Backer V, Kava TTK, Welte T, Omenaas ER, Bergqvist PBF, et al. Improvements in FEV1 are greater with budesonide/formoterol than with salmeterol/fluticasone. European Respiratory Society. 2003:P2‐19.
    1. Aalbers R, Backer V, Kava TTK, Welte T, Omenaas ER, Bergqvist PBF, et al. Is well‐controlled asthma weeks a useful measure? Fewer exacerbations in patients treated with budesonide/formoterol than salmeterol/fluticasone. European Respiratory Society. 2003:P2‐18.
    1. Welte T, Aalbers R, Naya I. Budesonide/formoterol adjustable maintenance dosing (B/F AMD) reduces the burden of asthma more effectively than fixed‐dosing (FD) with B/F or salmeterol/fluticasone (S/FL). European Respiratory Journal 2004;24(Suppl 48):508s.
Adinoff 1998 {published data only}
    1. Adinoff AD, Schwartz HJ, Rickard KA, Yancey SW, Swearingen BE. Salmeterol compared with current therapies in chronic asthma. Journal of Family Practice 1998;47(4):278‐84. - PubMed
Akpinarli 1999 {published data only}
    1. Akpinarli A, Tuncer A, Saraclar Y, Sekerel BE, Kalayci O. Effect of formoterol on clinical parameters and lung functions in patients with bronchial asthma: a randomised controlled trial. Archives of Disease in Childhood 1999;81:45‐8. - PMC - PubMed
Ankerst 2003 {published data only}
    1. Ankerst J, Persson G, Weibull E. Cardiovascular effects of a high dose of the budesonide/formoterol single inhaler in asthmatic patients. European Respiratory Journal 2001;18(Suppl 33):53s.
    1. Ankerst J, Persson G, Weibull E. Tolerability of a high dose of budesonide/formoterol in a single inhaler in patients with asthma. Pulmonary Pharmacology & Therapeutics 2003;16:147‐51. - PubMed
Anonymous 1999 {published data only}
    1. Anonymous. Levalbuterol for asthma. Drugs & Therapeutics 1999; Vol. 41, issue 1054:51‐3. - PubMed
Anonymous a 2003 {published data only}
    1. Anonymous. Flexible dosing of combination inhaler cuts asthma exacerbations . Pharmaceutical Journal 2003;271(7271):535.
Anonymous b 2003 {published data only}
    1. Anonymous. Asthma control with combination therapy. Fortschritte der Medizin 2003;145(46):46‐7. - PubMed
Anonymous c 2003 {published data only}
    1. Anonymous. Excess mortality with salmeterol as single‐agent therapy. Prescrire International 2003;12(66):142. - PubMed
Arvidsson 1991 {published data only}
    1. Arvidsson P, Larsson S, Lofdahl CG, Melander B, Svedmyr N, Wahlander L. Inhaled formoterol during one year in asthma: a comparison with salbutamol. [ENGLISH]. European Respiratory Journal 1991;4(10):1168‐73. - PubMed
Aubier 1999 {published data only}
    1. Aubier M, Pieters WR, Schlosser NJJ, Steinmetz KO. Salmeterol/fluticasone propionate (50/500 mug) in combination in a Diskus(TM) inhaler (Seretide(TM)) is effective and safe in the treatment of steroid‐dependent asthma. Respiratory Medicine 1999;93(12):876‐84. - PubMed
    1. Pieters WR, Lundback B, Sondhi S, Price MJ. Cost effectiveness analysis of salmeterol/fluticasone propionate 50/500mcg vs fluticasone propionate 500mcg in patients with corticosteroid ‐dependent asthma. Pharmacoeconomics 1999;16(Suppl 2):29‐34.
    1. Pieters WR, Sondhi S, Price MJ, Thwaites RM, Nyth A. The cost effectiveness of salmeterol/fluticasone propionate 50/500 microgram combination inhaler versus fluticasone propionate 500 microgram in patients with chronic asthma. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999:2458.
    1. Pieters WR, Steinmetz KO, Aubier M, Johnson L, Gomez E, Bogolubov M. Effectiveness of a new salmeterol/fluticasone propionate (50/500µg) combination inhaler in patients with reversible airways obstruction. European Respiratory Journal 1998; Vol. 12, issue Suppl 28:35s.
    1. Pieters WR, Wilson KK, Smith HCE, Tamminga JJ. Cost‐effectiveness of fluticasone propionate/salmeterol combination product and fluticasone propionate/montelukast in asthma. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Aziz 1998 {published data only}
    1. Aziz I, Hall IP, McFarlane LC, Lipworth BJ. Beta2‐adrenoceptor regulation and bronchodilator sensitivity after regular treatment with formoterol in subjects with stable asthma. Journal of Allergy & Clinical Immunology 1998;101(3):337‐41. - PubMed
Aziz 1999a {published data only}
    1. Aziz I, Lipworth BJ. A bolus of inhaled budesonide rapidly reverses airway subsensitivity and beta2‐adrenoceptor down‐regulation after regular inhaled formoterol. Chest 1999;115(3):623‐8. - PubMed
Aziz 1999b {published data only}
    1. Aziz I, Lipworth BJ. In vivo effect of albuterol on methacholine‐contracted bronchi in conjunction with salmeterol and formoterol. Journal of Allergy & Clinical Immunology 1999;103(5 part 1):816‐22. - PubMed
Aziz 2000 {published data only}
    1. Aziz I, Wilson AM, Lipworth BJ. Effects of formoterol (FM) and budesonide (BUD) alone or in combination (FM+BUD) on inflammatory markers in asthmatic patients. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999:2854.
    1. Aziz I, Wilson AM, Lipworth BJ. Effects of once‐daily formoterol and budesonide given alone or in combination on surrogate inflammatory markers in asthmatic adults. Chest 2000;118(4):1049‐58. - PubMed
Bacci 2002 {published data only}
    1. Bacci E, Franco A, Bartoli ML, Carnevali S, Cianchetti S, Dente FL, et al. Comparison of anti‐inflammatory and clinical effects of beclomethasone dipropionate and salmeterol in moderate asthma. European Respiratory Journal 2002;20(1):66‐72. - PubMed
Baki 1998 {published data only}
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Balachandran 2001 {published data only}
    1. Balachandran A, Shivbalan S, Subramanyam L. Drug therapy of childhood asthma. Indian Journal of Pediatrics 2001;68(Suppl 4):S12‐16. - PubMed
Balzano 2002 {published data only}
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Bateman 1998 {published data only}
    1. Bateman ED, Britton M, Carrillo J, Almeida J, Wixon C. Salmeterol/fluticasone combination inhaler. A new, effective and well tolerated treatment for asthma. Clinical Drug Investigation 1998;16(3):193‐201. - PubMed
Bateman 2001 {published data only}
    1. Bateman ED, Bantje TA, Gomes M, Toumbis M, Huber R, Eliraz A, et al. Symbicort (budesonide and formoterol in a single inhaler) is a more effective treatment than fluticasone in asthma patients. American Thoracic Society Abstracts. 2001.
    1. Bateman ED, Beasley R, Silins V, Bogolubov M. Comparison of salmeterol/fluticasone propionate combination 50/100 bid delivered via metered dose inhaler or diskus in patients with reversible airways obstruction. American Thoracic Society 2000 International Conference; May 5‐10; Toronto, Canada. 2000; Vol. 161 (Suppl 3):A197.
    1. Bateman ED, Silins V, Bogolubov M. Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 mcg twice daily) when administered via a chlorofluorocarbon‐free metered dose inhaler or dry powder inhaler to patients with mild‐to‐moderate asthma. Respiratory Medicine 2001;95(2):136‐46. - PubMed
    1. SFCB3022. A multicentre, randomised, double‐blind, double‐dummy, parallel‐group, three‐month comparison of the salmeterol/fluticasone propionate combination product (2x25/50mcg strength) bd via the pressurised metered dose inhaler with salmeterol/fluticasone propionate combination product (1x50/100mcg strength) bd via the Diskus/Accuhaler™ inhaler and with fluticasone propionate (2x 50mcg strength) alone bd via the pressurised metered dose inhaler in adolescents and adults with reversible airways obstruction. http://ctr.gsk.co.uk 2004 (accessed 4 June 2008).
Baumgarten 2002 {published data only}
    1. Baumgarten C, Geldszus R, Behre U, Peslis N, Trautmann M, Viani‐Initial Study Group. Initial treatment of symptomatic mild to moderate bronchial asthma with the salmeterol/fluticasone propionate (50/250 microg) combination product (SAS40023). European Journal of Medical Research 2002;7(1):1‐7. - PubMed
Beckett 2003 {published data only}
    1. Beckett P, Hewitt L, Woodcock A, Smith J, Seghal N, Rice L, et al. Improvement in airway hyper‐responsiveness (AHR) and lung function with salmeterol/fluticasone propionate combination (SFC) in persistent asthma [abstract]. American Thoracic Society 99th International Conference. 2003; Vol. D034 Poster C27.
Beeh 2002 {published data only}
    1. Beeh KM, Beier J, Kornmann O, Wiewrodt R, Buhl R. Efficacy and safety of salmeterol (50 [mu]g) and fluticasone (250 [mu]g) in a single inhaler device (Diskus(R)) in patients with mild to moderate asthma. Pneumologie 2002;56(2):91‐7. - PubMed
Behling 1999 {published data only}
    1. Behling B, Matthys H. Comparison of efficacy and safety of formoterol with terbutaline in children with mild to moderate asthma. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999.
Bennett 2002 {published data only}
    1. Bennett WD. Effect of beta‐adrenergic agonists on mucociliary clearance. Journal of Allergy & Clinical Immunology 2002; Vol. 110, issue Suppl 6:s291‐7. - PubMed
Bensch 2002 {published data only}
    1. Bensch G, Berger WE, Blokhnn M, Socolovshy AL, Thomson MH, Till MD, et al. One year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma. Annals of Allergy Asthma and Immunology 2002;89:180‐90. - PubMed
    1. Berger W, Bensch G, Blokhin BM, Socolovsky AL, Thompson MH, Till D. Addition of formoterol (Foradil®) improves lung function and symptoms in children with persistent asthma not controlled by inhaled corticosteroids. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Berggren 2001 {published data only}
    1. Berggren F, Ekstrom T. A cost‐effectiveness study comparing the as‐needed use of formoterol (Oxis) and terbutaline (Bricanyl) in patients with moderate to severe asthma.. Respiratory Medicine 2001;95(9):753‐8. - PubMed
Berlinski 2001 {published data only}
    1. Berlinski A, Waldrep JC. Metering performance of several metered‐dose inhalers with different spacers/holding chambers. Journal of Aerosol Medicine 2001;14(4):427‐32. - PubMed
Bernstein 2002 {published data only}
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Bijl‐Hofland 2001 {published data only}
    1. Bijl‐Hofland ID, Cloosterman SG, Folgering HT, Elshout FJ, Weel C. van Schayck CP. Inhaled corticosteroids, combined with long‐acting beta(2)‐agonists, improve the perception of bronchoconstriction in asthma. American Journal of Respiratory & Critical Care Medicine 2001;164(5):764‐9. - PubMed
Bjermer 2000 {published data only}
    1. Bjermer L, Bisgaard H, Bousquet J, Fabbri LM, Greening A, Haahtela T, et al. Montelukast or salmeterol combined with an inhaled steroid in adult asthma: design and rationale of a randomized, double‐blind comparative study (the IMPACT Investigation of Montelukast as a Partner Agent for Complementary Therapy‐trial). Respiratory Medicine. 2000;94(6):612‐21. - PubMed
    1. Bjermer L, Greening A, Haahtela T, Bousquet J, Holgate ST, Picado C, Bisgaard H, et al. Addition of montelukast or salmeterol to fluticasone in patients with uncontrolled asthma: results of the IMPACT trial. Chest (conference); San Diego, CA. 2002:434.
Boonsawat 2003 {published data only}
    1. Boonsawat W, Charoenratanakul S, Pothirat C, Sawanyawisuth K, Seearamroongruang T, Bengtsson T, et al. Formoterol (OXIS) Turbuhaler as a rescue therapy compared with salbutamol pMDI plus spacer in patients with acute severe asthma . Respiratory Medicine 2003;97(9):1067‐74. - PubMed
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    1. Booth H, Fishwick K, Harkawat R, Devereux G, Hendrick DJ, Walters EH. Changes in methacholine induced bronchoconstriction with the long acting beta 2 agonist salmeterol in mild to moderate asthmatic patients . Thorax 1993;48(11):1121‐4. - PMC - PubMed
Boulet 1998 {published data only}
    1. Boulet LP, Turcotte H, Cartier A, Milot J, Cote J, Malo JL, et al. Influence of beclomethasone and salmeterol on the perception of methacholine‐induced bronchoconstriction. Chest 1998;114(2):373‐9. - PubMed
Boyd 1995 {published data only}
    1. Boyd G. Salmeterol xinafoate in asthmatic patients under consideration for maintenance oral corticosteroid therapy. European Respiratory Journal 1995;8:1494‐8. - PubMed
Brambilla 1994 {published data only}
    1. Brambilla C, Chastang C, Georges D, Bertin L. Salmeterol compared with slow‐release terbutaline in nocturnal asthma. Allergy 1994;49(6):421‐6. - PubMed
Braunstein 2002 {published data only}
    1. Braunstein G. Optimization of asthma control with fluticasone/salmeterol (Seretide) combination: new clinical data. Revue De Pneumologie Clinique 2002; Vol. 58, issue 3 part 2:s12‐5. - PubMed
Brenner 1988 {published data only}
    1. Brenner M, Berkowitz R, Marshall N, Strunk RC. Need for theophylline in severe steroid‐requiring asthmatics. Clinical Allergy 1988;18(2):143‐50. - PubMed
Britton 1992 {published data only}
    1. Britton MG, Earnshaw JS Palmer JBD. A twelve month comparison of salmeterol with salbutamol in asthmatic patients. European Respiratory Journal 1992;5(9):1062‐7. - PubMed
Britton 1998 {published data only}
    1. Britton MG, Carrillo T, Almeida J, Wixon C. Combined Serevent™ and fluticasone propionate (50/100µg strength) bd via one Diskus™ (accuhaler™) inhaler compared with salmeterol 50µg and fluticasone propionate 100µg bd via two separate Diskus inhalers. American Journal of Respiratory and Critical Care Medicine 1998; Vol. 157, issue Suppl 3:A415.
Brogden 1991 {published data only}
    1. Brogden RN, Faulds D. Salmeterol xinafoate. A review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs 1991;42(5):895‐912. - PubMed
Buchvald 2003 {published data only}
    1. Buchvald F, Bisgaard H. Comparisons of the complementary effect on exhaled nitric oxide of salmeterol vs montelukast in asthmatic children taking regular inhaled budesonide. Annals of Allergy, Asthma, and Immunology 2003;91(3):309‐13. - PubMed
    1. Buchvald FF, Bisgaard H. Comparison of add‐on of leukotriene receptor antagonist versus long‐acting beta2‐agonist on FeNO in asthmatic children on regular inhaled budesonide. European Respiratory Society Annual Congress. 2002:P2736.
Buhl 2003a {published data only}
    1. AstraZeneca (SD 039 0666). Symbicort high dose once daily in mild to moderate asthmatic patients. http://www.astrazenecaclinicaltrials.com 2000 (accessed 30 April 2008).
    1. Buhl R, Creemers JPHM, Vondra V, Martelli NA. Improved and maintained asthma control with once‐daily budesonide/formoterol single inhaler in mild‐to‐moderate persistent asthma. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:21s.
    1. Buhl R, Creemers JPHM, Vondra V, Martelli NA. Once daily Symbicort (budesonide/eformoterol in a single inhaler) is effective in moderate‐persistent asthma. Thorax 2001;56(Suppl 3):iii 62.
    1. Buhl R, Creemers JPHM, Vondra V, Martelli NA. Once‐daily budesonide/formoterol via a single inhaler is effective in mild‐to‐moderate persistent asthma. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:21s.
    1. Buhl R, Creemers JPHM, Vondra V, Martelli NA. Symbicort® (budesonide and formoterol in a single inhaler) administered once daily is effective in mild to moderate asthma. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Buhl 2003b {published data only}
    1. Boushey H, Bateman E, Bousquet J, Busse W, Clark T, Pauwels R, et al. Achieving total control of asthma with salmeterol/fluticasone propionate versus fluticasone propionate alone: GOAL study results. 4th Triennial World Asthma Meeting. 2004.
    1. Brambilla C, Gros V, Bourdeix I. Formoterol 12 mug BID administered via single‐dose dry powder inhaler in adults with asthma suboptimally controlled with salmeterol or on‐demand salbutamol: a multicenter, randomized, open‐label, parallel‐group study. Clinical Therapeutics 2003;25(7):2022‐36. - PubMed
    1. Buchvald F, Bisgaard H. Comparisons of the complementary effect on exhaled nitric oxide of salmeterol vs montelukast in asthmatic children taking regular inhaled budesonide. Annals of Allergy, Asthma, and Immunology 2003;91(3):309‐13. - PubMed
    1. Buchvald FF, Bisgaard H. Comparison of add‐on of leukotriene receptor antagonist vs. long‐acting beta2‐agonist on FeNO in asthmatic children on regular inhaled budesonide. European Respiratory Society Annual Congress. 2002:P2736.
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Buhl 2003c {published data only}
    1. Buhl R. Budesonide/formoterol for the treatment of asthma. Expert Opinion in Pharmacotherapy 2003;4(8):1393‐406. - PubMed
Busse 1999 {published data only}
    1. Busse W, Nelson H, Wolfe J, Kalberg C, Yancey SW, Rickard KA. Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma. Journal of Allergy & Clinical Immunology 1999;103(6):1075‐80. - PubMed
Byrnes 2000 {published data only}
    1. Byrnes C, Shrewsbury S, Barnes PJ, Bush A. Salmeterol in paediatric asthma. Thorax 2000;55(9):780‐4. - PMC - PubMed
Calhoun 2001 {published data only}
    1. Calhoun WJ, Nelson HS, Nathan RA, Pepsin PJ, Kalberg C, Emmett A, et al. Comparison of fluticasone propionate‐salmeterol combination therapy and montelukast in patients who are symptomatic on short‐acting 2‐agonists alone. American Journal of Respiratory and Critical Care Medicine 2001;164(5):759‐63. - PubMed
Calverley 2002 {published data only}
    1. Calverley PMA, Pauwels RA, Vestbo J, Jones PW, Pride NB, Gulsvik A, et al. Salmeterol/fluticasone propionate combination for one year provides greater clinical benefit than its individual components in COPD. American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A226.
Castle 1993 {published data only}
    1. Castle W, Fuller R, Hall J, Palmer J. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ 1993;113(306):1034‐7. - PMC - PubMed
Cazzola 2000 {published data only}
    1. Cazzola M, Lorenzo G, Perna F, Calderaro F, Testi R, Centanni S. Additive effects of salmeterol and fluticasone or theophylline in COPD. Chest 2000;118(6):1576‐81. - PubMed
Chalmers 1999 {published data only}
    1. Chalmers GW, Macleod KJ, Thomson LJ, Little SA, Patel KR, McSharry C, et al. Sputum cellular and cytokine responses to inhaled endothelin‐1 in asthma. Clinical & Experimental Allergy 1999;29(11):1526‐31. - PubMed
Chan 2001 {published data only}
    1. Chan JS, Cowie RL, Lazarenko GC, Little C, Scott S, Ford GT. Comparison of intramuscular betamethasone and oral prednisone in the prevention of relapse of acute asthma. Canadian Respiratory Journal. 2001;8(3):147‐52. - PubMed
Chapman 1999 {published data only}
    1. Chapman KR, Ringdal N, Backer V, Palmqvist M, Saarelainen S, Briggs M. Salmeterol and fluticasone propionate (50/250 mug) administered via combination Diskus inhaler: as effective as when given via separate Diskus inhalers. Canadian Respiratory Journal 1999;6(1):45‐51. - PubMed
Cheer 2003 {published data only}
    1. Cheer SM, Warner GT, Easthope SE. Formoterol delivered by Turnuhaler in paediatric asthma. Paediatric Drugs 2003;5(1):63‐8. - PubMed
Chuchalin 2002 {published data only}
    1. Chuchalin AG, Ovcharenko SI, Goriachkina LA, SIdorenko IV, Tsoi AN. The safety and efficacy of formoterol (Oxis) turbuhaler plus budesonide (Pulmicort) turbuhaler in mild to moderate asthma: a comparison with budesonide turbuhaler alone and current non‐corticosteroid therapy in Russia. International Journal of Clinical Practice 2002;56(1):15‐20. - PubMed
    1. Chuchalin AG, Ovcharenko SI, Goriachkina LA, Sidorenko IV, Tsoi AN. Formoterol (Oxis®) Turbuhaler® plus budesonide turbuhaler® is more effective than current non‐steroid therapy and budesonide alone in mild to moderate asthma in Russia. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
    1. Chuchalin AG, Stahl E, Svensson K, Ovcharenko SI, Goriachkina LA, Sidorenko IV, et al. Formoterol (Oxis®) Turbuhaler® plus budesonide Turbuhaler® and budesonide alone improve health‐related quality of life vs non‐steroid therapy in mild to moderate asthma in Russia. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
    1. Chuchalin AG, Svensson K, Stahl E, Ovcharenko SI, Goriachkina LA, Sidorenko IV, et al. A health‐related quality‐of‐life comparison of formoterol (Oxis(R)) Turbuhaler(R) plus budesonide (Pulmicort(R)) Turbuhaler(R) with budesonide Turbuhaler(R) alone and noncorticosteroid treatment in asthma: a randomized clinical study in Russia. Respiration 2002;69(5):427‐33. - PubMed
    1. Kuna P, Chuchalin A, Ringdal N, Padilla EA, Black P, Lindqvist A, et al. Low‐dose single‐inhaler budesonide/formoterol administered once daily is effective in mild‐persistent asthma. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:158s.
Chuchalin 2008 {unpublished data only}
    1. Chuchalin A, Jacques L, Frith L. Salmeterol/fluticasone propionate via Diskus[TM] once daily versus fluticasone propionate twice daily in patients with mild asthma not previously receiving maintenance corticosteroids. Clinical Drug Investigation 2008;28(3):169‐81. - PubMed
    1. Glaxo Smith Kline (SAS30024). A 52‐week multicentre, randomised, double‐blind, double dummy, placebo‐controlled parallel group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE/VIANI/ADVAIR) 50/100mcg once daily in the morning with fluticasone propionate (FLIXOTIDE/FLOVENT) 100mcg twice daily and placebo twice daily, all via the DISKUS/ACCUHALER as initial maintenance therapy in mild asthmatic subject. http://ctr.gsk.co.uk 2005.
Cloosterman 2001 {published data only}
    1. Cloosterman SG, Bijl‐Hofland ID, Herwaarden CL, Akkermans RP, Elshout FJ, Folgering HT, et al. A placebo‐controlled clinical trial of regular monotherapy with short‐acting and long‐acting beta(2)‐agonists in allergic asthmatic patients. Chest 2001;119(5):1306‐15. - PubMed
Condemi 2001 {published data only}
    1. Condemi JJ. Comparison of the efficacy of formoterol and salmeterol in patients with reversible obstructive airway disease: a multicenter, randomized, open‐label trial. Clinical Therapeutics 2001;23(9):1529‐41. - PubMed
Creticos 1999 {published data only}
    1. Creticos PS, Freidhoff LR, Bernstein DI, Chu T, Khattignavong AP, Pasatiempo AM. Comparison of an inhaled corticosteroid (triamcinolone acetonide) to a long‐acting bronchodilator (salmeterol), the combination, and placebo in mild‐moderate adult asthmatic patients. International Archives of Allergy and Immunology 1999;118:345‐6. - PubMed
Crompton 1999 {published data only}
    1. Crompton G K, Ayres JG, Basran G, Schiraldi G, Brusasco V, Eivindson A, et al. Comparison of oral bambuterol and inhaled salmeterol. American Journal of Respiratory & Critical Care Medicine 1999;159(3):824‐8. - PubMed
Currie 2003a {published data only}
    1. Currie GP, Lee DKC, Haggart K, Bates CE, Lipworth BJ. Effects of montelukast on surrogate inflammatory markers in corticosteroid‐treated patients with asthma. American Journal of Respiratory and Critical Care Medicine 2003;167(9):1232‐8. - PubMed
Currie 2003b {published data only}
    1. Currie GP, Bates CE, Lee DKC, Jackson CM, Lipworth BJ. Effects of fluticasone plus salmeterol versus twice the dose of fluticasone in asthmatic patients. European Journal of Clinical Pharmacology 2003;59(1):11‐5. - PubMed
Currie 2003c {published data only}
    1. Currie GP, Lee DK, Dempsey OJ, Fowler SJ, Cowan LM, Lipworth BJ. A proof of concept study to evaluate putative benefits of montelukast in moderate persistent asthmatics. British Journal of Clinical Pharmacology 2003;55(6):609‐15. - PMC - PubMed
D'Alonzo 1994 {published data only}
    1. D'Alonzo GE, Nathan RA, Henochowicz, Morris RJ, Ratner P, Rennard SI. Salmetrol xinafoate as maintenance therapy compared with albuterol in patients with asthma. JAMA 1994;271:1412‐16. - PubMed
D'Urzo 2001 {published data only}
    1. D'Urzo AD, Chapman KR, Cartier A, Hargreave FE, Fitzgerald M, Tesarowski D. Effectiveness and safety of salmeterol in non‐specialist practice settings. Chest 2001;119:714‐19. - PubMed
Dahl 1989 {published data only}
    1. Dahl R, Pedersen B, Hagglof B. Nocturnal asthma: effect of treatment with oral sustained‐release terbutaline, inhaled budesonide, and the two in combination. Journal of Allergy & Clinical Immunology 1989;83(4):811‐5. - PubMed
Dahl 1991 {published data only}
    1. Dahl R, Earnshaw JS, Palmer JBD. Salmeterol: a four week study of a long‐acting beta‐adrenoceptor agonist for the treatment of reversible airways disease. European Respiratory Journal 1991;4(10):1178‐84. - PubMed
Dal Negro 2001a {published data only}
    1. Dal Negro R, Micheletto C, Tognella S, Trevisan F, Pomari C. Short‐term bronchodilation following salmeterol 50mcg and combined salmeterol + fluticasone p (50/250mcg) via Diskus: a randomized, double blind cross‐over study in reversible airway obstruction . Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Dal Negro 2001b {published data only}
    1. Dal Negro RW, Micheletto C, Pomari C, Trevisan F, Tognella S. The combination salmeterol (S) + fluticasone propionate (F) in mild‐to‐moderate asthma. European Respiratory Journal. 2001; Vol. 18, issue Suppl 33:426s.
Dal Negro 2002 {published data only}
    1. Dal Negro R, Micheletto C, Trevison F, Tognells S, Pomari C, Spencer S. Salmeterol & fluticasone 50µg/250µg bid versus salmeterol 50µg bid and vs placebo in the long‐term treatment of COPD. American Journal of Respiratory and Critical Care Medicine 2002, issue Suppl 8:A228.
Davis 2001 {published data only}
    1. Davis ES, Bowers B, Pepsin P, Kalberg C, Dorinsky P. The impact of fluticasone propionate/salmeterol combination product compared to oral montelukast on asthma related quality of life. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Dekhuijzen 2002 {published data only}
    1. Dekhuijzen PNR, Diamant Z. The role of montelukast, a leukotriene receptor antagonist, in the treatment of asthma. Pharmaceutisch Weekblad 2002;137(1):38‐9.
Del Rio Navarro 2001a {published data only}
    1. Rio Navarro BE, Sienra‐Monge JJL, Alvarez‐Amador M, Reyes‐Ruiz N, Arevalo‐Salas A, Berber A. Serum potassium levels, CPK‐MB and ECG in children suffering asthma treated with beclomethasone or beclomethasone‐salmeterol. Allergologia et Immunopathologia 2001;29(1):16‐21. - PubMed
Del Rio Navarro 2001b {published data only}
    1. Rio BE, Corona L, Fregosa R, Berber A, Magana J, Sienra‐Monge JL. Effect of salmeterol and salmeterol plus beclomethasone on the saliva flow and saliva IgA levels on patients with chronic moderate persistent asthma (CMPA). Journal of Allergy and Clinical Immunology 2001; Vol. 107, issue 2:s11. - PubMed
    1. Rio Navarro BE, Coron‐Hernandez L, Fragoso‐Rios R, Berber A, Torres‐Alcantara S, Cuairan‐Ruidiaz V, et al. Effect of salmeterol and salmeterol plus beclomethasone on saliva flow and IgA in patients with moderate‐persistent chronic asthma. Annals of Allergy, Asthma, and Immunology 2001;87(5):420‐3. - PubMed
Dente 2001 {published data only}
    1. Dente FL, Scuotri L, Bacci E, DeSanctis M, Franco A, Giannini D, et al. Combined treatment with fluticasone plus salmeterol protects against allergen‐induced asthmatic responses better than each drug alone. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:349s.
    1. Dente FL, Scuotri L, Bacci E, Franco A, Giannini D, Taccola M, et al. Effects of combined treatment ‐ fluticasone plus salmeterol ‐ on allergen‐induced asthmatic responses. American Journal of Respiratory and Critical Care Medicine Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001; Vol. 463, issue supp 5:A419.
Di Franco 1999 {published data only}
    1. Franco A, Giannini D, Bacci E, Dente FL, Vagaggini B, Paggiaro PL. Comparison of different long‐term asthma treatments in subjects with mild‐to‐moderate asthma. Monaldi Archives for Chest Disease 1999;54(5):390‐3. - PubMed
Dicpinigaitis 2002 {published data only}
    1. Dicpinigaitis PV, Dobkin JB, Reichel J. Antitussive effect of the leukotriene receptor antagonist zafirlukast in subjects with cough‐variant asthma. Journal of Asthma 2002;39(4):291‐7. - PubMed
Didier 1997 {published data only}
    1. Didier A, Campos Oriola R. A two‐month comparison of salmeterol/beclomethasone and slow‐release terbutaline/budesonide in moderate asthma management. Clinical Drug Investigation 1997;14(1):1‐11.
Dorinsky 2001 {published data only}
    1. Dorinsky P, Kalberg C, Pepsin P, Emmett A, Bowers B, Rickard K. The fluticasone/salmeterol combination product is superior to montelukast as first‐line asthma control. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:263s.
    1. Dorinsky PM, Kalberg C, Pepsin P, Emmett A, Rickard K. Greater onset of improvement in clinical efficacy measures with first line use of the fluticasone/salmeterol combination product compared to montelukast. Annual Thoracic Society 97th International Conference; San Francisco CA May 18‐23. 2001. 2001.
Dorinsky 2002 {published data only}
    1. Dorinsky P, Jones S, Kalberg C, Emmett A, Rickard K. Sustained protection against activity‐induced bronchospasm (AIB) during chronic treatment with the fluticasone propionate/salmeterol combination (FSC). American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A568.
Durham 1999 {published data only}
    1. Durham S. Long acting inhaled beta2‐agonists: anti‐inflammatory effects not evident during treatment of day to day asthma. European Respiratory Journal 1999;14(2):249‐50. - PubMed
Ek 2000 {published data only}
    1. Ek A, Palmberg L, Larsson K. Influence of fluticasone and salmeterol on airway effects of inhaled organic dust;an in vivo and ex vivo study. Clinical & Experimental Immunology 2000;121(1):11‐6. - PMC - PubMed
Eliraz 2001a {published data only}
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Eliraz 2001b {published data only}
    1. Eliraz A, Ramirez‐Rivera A, Ferranti P, Holzer R, Garcia JM, Turcotte C, et al. Similar efficacy following four weeks treatment of asthmatics with formoterol 12 mcg BD delivered by two different dry powder inhalers; differences in inhaler handling. International Journal of Clinical Practice 2001;55(3):164‐70. - PubMed
Eliraz 2002 {published data only}
    1. Eliraz A, Fritscher CC, Perez CMR, Boonsawat W, Nang AN, Bardin P, et al. Symbicort® (budesonide/formoterol) achieves more rapid control of asthma that fluticasone in patients with mild asthma. American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A567.
Ericsson 2001 {published data only}
    1. Ericsson K, Bantje TA, Huber R, Borg S, Andersson F. Symbicort Turbohaler is more effective than fluticasone Diskus in the treatment of asthma. Thorax 2001; Vol. 56, issue Suppl 3:iii 63.
Everden 2002 {published data only}
    1. Everden P, Lloyd A, Hutchinson J, Plumb J. Cost‐effectiveness of eformoterol Turbohaler(R) versus salmeterol Accuhaler(R) in children with symptomatic asthma. Respiratory Medicine 2002;96(4):250‐8. - PubMed
Faurschou 1994 {published data only}
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Faurschou 1996 {published data only}
    1. Faurschou P, Steffensen I, Jacques L. Effect of addition of inhaled salmeterol to the treatment of moderate‐to‐severe asthmatics uncontrolled on high‐dose inhaled steroids. European Respiratory Journal 1996;9(9):1885‐90. - PubMed
Fish 2001 {published data only}
    1. Fish J, Boone R, Emmett A, Yancey S, Knobil K, Rickard K. Salmeterol added to inhaled corticosteroids (ICS) provides greater asthma control compared to montelukast. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue Suppl 3:A203.
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Fitzgerald 1999 {published data only}
    1. Fitzgearld JM, Chapman KR, Della Cioppa G, Stubbing D, Fairbarn MS, Till MD, et al and The Canadian FO/OD1 Study Group. Sustained bronchoprotection, bronchodilatation and symptom control during regular formoterol use in asthma of moderate or greater severity. Journal of Allergy and Clinical Immunology 1999;103(3 Pt 1):427‐35. - PubMed
Fitzpatrick 1990 {published data only}
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Fuglsang 1995 {published data only}
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Garcia‐Marcos 2003 {published data only}
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    1. Gessner C, Stenglein S, Brautigam M, Muller A, Schauer J. Miflonide/Foradil via Aerolizer compared with other anti‐inflammatory and anti‐obstructive therapeutic regimens. Pneumologie 2003;57(3):137‐43. - PubMed
Giannini 1996 {published data only}
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Giannini 1998 {published data only}
    1. Giannini D, Franco A, Bacci E, Conti I, Dente FL, Kotopulos C, et al. Long‐term treatment with salmeterol and inhaled corticosteroids does not induce tolerance to the protective effect of salmeterol on allergen challenge. American Journal of Respiratory and Critical Care Medicine 1998; Vol. 157, issue Suppl 3:A414.
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Giannini 1999 {published data only}
    1. Giannini D, Bacci E, Dente FL, Franco A, Vagaggini B, Testi R, et al. Inhaled beclomethasone dipropionate reverts tolerance to the protective effect of salmeterol on allergen challenge. Chest 1999;115(3):629‐34. - PubMed
Giannini 2000 {published data only}
    1. Giannini D, Franco A, Bacci E, Dente FL, Taccola M, Vagaggini B, et al. The protective effect of salbutamol inhaled using different devices on methacholine bronchoconstriction. Chest 2000;117(5):1319‐23. - PubMed
Giannini 2001 {published data only}
    1. Giannini D, Tonelli M, Franco A, Bacci E, Conti I, Dente FL, et al. Tolerance to the protective effect of salmeterol on allergen challenge in mild untreated asthmatics and in moderate asthmatics on inhaled corticosteroid treatment . European Respiratory Journal 2001; Vol. 18, issue Suppl 33:103s.
Giannini 2002 {published data only}
    1. Giannini D, Tonelli M, Franco A, Bacci E, Conti I, Dente FL, et al. Tolerance to the protective effect of salmeterol + fluticasone combination (50/250 µg) on allergen challenge in mild untreated asthmatics. American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A566.
Gizycki 2000 {published data only}
    1. Gizycki MJ, Venge P, Dahl R, Jeffery PK. Comparison of the effects of six weeks treatment with fluticasone or salmeterol on the late phase response (LPR) in mild asthma ‐ a bronchial biopsy study. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue Suppl 3:A203.
GOAL {published data only}
    1. Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE, GOAL Investigators Group. Can guideline‐defined asthma control be achieved? The Gaining Optimal Asthma ControL study . American Journal of Respiratory & Critical Care Medicine 2004;170(8):836‐44. - PubMed
Gold 2001 {published data only}
    1. Gold M, Jõgi R, Mulder PGH, Akveld MLM. Salmeterol/fluticasone propionate combination 50/100µg bid is more effective than fluticasone propionate 100µg bid plus montelukast 10 mg once daily in reducing exacerbations. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:262s.
Grootendorst 2001 {published data only}
    1. Grootendorst DC, Dahlen SE, Bos JW, Duiverman EJ, Veselic‐Charvat M, Vrijlandt EJ, et al. Benefits of high altitude allergen avoidance in atopic adolescents with moderate to severe asthma, over and above treatment with high dose inhaled steroids. Clinical and Experimental Allergy 2001;31(3):400‐8. - PubMed
Grutters 1999 {published data only}
    1. Grutters J, Brinkman L, Koenderman L, Bosch J, Lammers JW. The effect of treatment of allergic asthmatics with salmeterol (SLM), beclomethasone (BDP) or the combination on lung function and bronchial hyper‐responsiveness (BHR) after allergen challenge. European Respiratory Journal 1997; Vol. 10, issue Suppl 25:474s.
    1. Grutters JC, Brinkman L, Aslander MM, Bosch JMM, Koenderman L, Lammers JMJ. Asthma modulates priming ‐ associated blood eosinophil responsiveness in allergic asthmatics. European Respiratory Journal 1999;14:915‐22. - PubMed
Gustafsson 1994 {published data only}
    1. Gustafsson PM, Von BA, Jenkins MM. Salmeterol 50 mug twice daily in the treatment of mild‐to‐moderate asthma in childhood ‐ a comparison of two inhalation devices. European Journal of Clinical Research 1994;5:63‐73.
Hacki 2001 {published data only}
    1. Hacki M, Knoblauch A, Leuppi J. Asthma treatment. Pharma‐Kritik 2001;23(16):61‐4.
Hasani 2003 {published data only}
    1. Hasani A, Toms N, O'Connor J, Dilworth J P, Agnew JE. Effect of salmeterol xinafoate on lung mucociliary clearance in patients with asthma. Respiratory Medicine 2003;97(6):667‐71. - PubMed
Heyneman 2002 {published data only}
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Hultquist 2000 {unpublished data only}
    1. Hultquist C. Unpublished data. Personal communication 2000.
Ind 2002 {published data only}
    1. Ind PW, Villasante C, Shiner RJ, Pietinalho A, Boszormenyi NG, Soliman S, et al. Safety of formoterol by Turbuhaler as reliever medication compared with terbutaline in moderate asthma. European Respiratory Journal 2002;20(4):859‐66. - PubMed
Isabelle 2001 {published data only}
    1. Isabelle P, Bjamer D, Neuparth N, Desfougeres JL. Efficacy and safety of salmeterol/fluticasone combination 50/100mug bd via two different powder devices in children. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Jarvis 1999 {published data only}
    1. Jarvis B, Faulds D. Inhaled fluticasone propionate. A review of its therapeutic efficacy at dosages <= 500 mug/day in adults and adolescents with mild to moderate asthma. Drugs 1999;57(5):769‐803. - PubMed
Jeffery 2002 {published data only}
    1. Jeffery PK, Venge P, Gizycki MJ, Egerod I, Dahl R, Faurschou P. Effects of salmeterol on mucosal inflammation in asthma: a placebo‐controlled study. European Respiratory Journal 2002;20(6):1378‐85. - PubMed
Jenkins 2002a {published data only}
    1. Jenkins C, Wilson J, Rutherford C, Perry AS, Whitehead PJ. Asthma management costs are lower with combination fluticasone/salmeterol (25/50 mcg BD) in a single inhaler than with budesonide (800 mcg BD) plus eformoterol (12 mcg BD) via separate inhalers. 2002. Respirology 2002; Vol. 7, issue Suppl:A20. [P23]
Jenkins 2002b {published data only}
    1. Jenkins C. Combination therapy with fluticasone and salmeterol for symptomatic asthma produces similar benefits when given by accuhaler in a single or two separate devices over 24 weeks. Respirology 2002; Vol. 7, issue Suppl:A20. [P22]
Johansson 1999 {published data only}
    1. Johansson G, Price MJ, Sondhi S. Cost‐effectiveness analysis of salmeterol/fluticasone propionate 50/100mug versus fluticasone propionate 100mug in adults and adolescents with asthma III. Pharmacoeconomics 1999;16(Suppl 2):15‐21.
Jones 1994 {published data only}
    1. Jones KP. Salmeterol xinafoate in the treatment of mild to moderate asthma in primary care. Thorax 1994;49:971‐5. - PMC - PubMed
Juniper 1995 {published data only}
    1. Juniper EF, Johnston PR, Borkhoff CM, Guyatt GH, Boulet LP, Haukioja A. Quality of life in asthma clinical trials: comparison of salmeterol and salbutamol. American Journal of Respiratory & Critical Care Medicine 1995;151(1):66‐70. - PubMed
Juniper 1999 {published data only}
    1. Juniper EF, Svenson K, O'Byrne PM, Barnes PJ, Bauer C‐A, Lofdahl C‐GA, et al. Asthma quality of life during 1 year of treatment with budesonide with or without formoterol. European Respiratory Journal 1999;14:1038‐43. - PubMed
Kalra 1996 {published data only}
    1. Kalra S, Swystun VA, Bhagat R, Cockcroft DW. Inhaled corticosteroids do not prevent the development of tolerance to the bronchoprotective effect of salmeterol. Chest 1996;109(4):953‐6. - PubMed
Kardos 2001 {published data only}
    1. Kardos P, Bruggenjurgen B, Martin A, Meyer‐Sabellek W, Richter K, Vogelmeier C, et al. Treatment of bronchial asthma using a new adjustable combination treatment plan: Asthma Control Plan (ATACO) [German]. Pneumologie 2001;55(5):253‐7. - PubMed
Kavuru 2000 {published data only}
    1. Edin HM, Payne E, Herrle MR, Schoaf L, Mather DB, Scott CA, et al. Salmeterol/fluticasone propionate combination via HFA MDI improves quality of life in asthma patients. Journal of Allergy and Clinical Immunology 2001; Vol. 107, issue 2:s246.
    1. Edin HM, Prillaman B, Baitinger LA, House K, Shah TP. Improved ability to perform strenuous activities after treatment with fluticasone propionate‐salmeterol combination. American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A112.
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    1. Johansson G, Price MJ, Sondhi S. Cost‐effectiveness analysis of salmeterol/fluticasone propionate 50/100mug vs fluticasone propionate 100mug in adults and adolescents with asthma III: results. Pharmacoeconomics 1999;16(Suppl 2):15‐21.
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Keating 2002 {published data only}
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Keith 2001 {published data only}
    1. Cowie R, Boulet LP, Stepner N, Simms L, Johnson D, Scott C, et al. Fluticasone propionate/salmeterol (FSC) Hfa MDI therapy provides effective control in the long‐term (1 year) management of patients with persistent asthma (PA). American Journal of Respiratory and Critical Care Medicine 2001;163(Suppl 5):A862.
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Kemp 1984 {published data only}
    1. Kemp JP, Chervinsky P, Orgel HA, Meltzer EO, Noyes JH, Mingo TS. Concomitant bitolterol mesylate aerosol and theophylline for asthma therapy, with 24 hr electrocardiographic monitoring. Journal of Allergy & Clinical Immunology 1984;73(1 part 1):32‐43. - PubMed
Kemp 1998 {published data only}
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Ketchell 2002 {published data only}
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Kidney 1995 {published data only}
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Kirby 2000 {published data only}
    1. Kirby S, Falcoz C, Daniel MJ, Milleri S, Squassante L, Ziviani L, et al. Salmeterol and fluticasone propionate given as a combination: lack of systemic pharmacodynamic and pharmacokinetic interactions. European Journal of Clinical Pharmacology 2000;56(11):781‐91. - PubMed
Knobil 2000 {published data only}
    1. Knobil K, Dorinsky P, Yancey S, Emmett A, Rickard K. Salmeterol is superior to montelukast as add‐on therapy to inhaled corticosteroids. European Respiratory Journal 2000; Vol. 16, issue Suppl 31:457s.
Knorr 2001 {published data only}
    1. Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, et al. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001;108(3):E48. - PubMed
Kopp 2002 {published data only}
    1. Kopp M. Antiinflammatory therapy in different age groups. Arztliche Praxis Padiatrie 2002, issue 2:28‐9.
Kraft 2003 {published data only}
    1. Kraft M, Martin RJ, Lazarus SC, Fahy JV, Boushey HA, Lemanske Jr RF, et al. Airway tissue mast cells in persistent asthma: predictor of treatment failure when patients discontinue inhaled corticosteroids. Chest 2003;124(1):42‐50. - PubMed
Kuna 2002 {published data only}
    1. Kuna P, Kuprys I. Symbicort Turbuhaler: a new concept in asthma management . International Journal of Clinical Practice 2002;56(10):797‐803. - PubMed
LaForce 1994 {published data only}
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Lai 1995 {published data only}
    1. Lai CKW, Chan CHS, Ho SS, Hui ACF, Lai KN. Inhaled salmeterol and albuterol in asthmatic patients receiving high‐dose inhaled corticosteroids. Chest 1995;108:36‐40. - PubMed
Lange 2001 {published data only}
    1. Lange ML, House KW, Scott CA, Shah TP, Akveld MLM. The salmeterol/fluticasone propionate combination 50/100µg bid is effective as initial maintenance therapy in mild and moderate asthmatics. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:176s.
Langton Hewer 1995 {published data only}
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Lazarus 2001 {published data only}
    1. Lazarus SC, Boushey HA, Fahy JV, Chinchilli VM, Lemanske RF Jr, Sorkness CA, et al. Long‐acting beta2 agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trial. JAMA 2001;285(20):2583‐93. - PubMed
Leblanc 1996 {published data only}
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Lemanske 2001 {published data only}
    1. Lemanske RF, Sorkness C, Mauger E, Lazarus S, Boushey H, Fahy J, et al. Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: a randomized controlled trial. JAMA 2001;285(20):2594‐603. - PubMed
Lenney 1995 {published data only}
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LHSRG 2000 {published data only}
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Lindqvist 2001 {published data only}
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Lipworth 1998 {published data only}
    1. Lipworth B, Tan S, Devlin M, Aiken T, Baker R, Hendrick D. Effects of treatment with formoterol on broncho‐protection against methacholine. American Journal of Medicine 1998;104(5):431‐8. - PubMed
Lipworth 1999a {published data only}
    1. Lipworth BJ, Hall IP, Aziz I, Tan KS, Wheatley A. Beta2‐adrenoceptor polymorphism and broncho‐protective sensitivity with regular short‐ and long‐acting beta2‐agonist therapy. Clinical Science. 1999;96(3):253‐9. - PubMed
Lipworth 1999b {published data only}
    1. Lipworth BJ, Aziz I. A high dose of albuterol does not overcome broncho‐protective sub‐sensitivity in asthmatic subjects receiving regular salmeterol or formoterol. Journal of Allergy & Clinical Immunology. 1999;103(1 part 1):88‐92. - PubMed
Lipworth 2000 a {published data only}
    1. Lipworth BJ, Dempsey OJ, Aziz I. Functional antagonism with formoterol and salmeterol in asthmatic patients expressing the homozygous glycine‐16 beta(2)‐adrenoceptor polymorphism. Chest 2000;118(2):321‐8. - PubMed
Lipworth 2000 b {published data only}
    1. Lipworth BJ, Dempsey OJ, Aziz I, Wilson AM. Effects of adding a leukotriene antagonist or a long‐acting beta(2)‐agonist in asthmatic patients with the glycine‐16 beta(2)‐adrenoceptor genotype. American Journal of Medicine 2000;109(2):114‐21. - PubMed
Lipworth 2002 {published data only}
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Lockey 1999 {published data only}
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    1. Lowhagen O, Wever AMJ, Lusuardi M, Moscato G, Backer WA, Gandola L, et al. The inflammatory marker serum eosinophil cationic protein (ECP) compared with PEF as a tool to decide inhaled corticosteroid dose in asthmatic patients. Respiratory Medicine 2002;96(2):95‐101. - PubMed
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    1. Lucioni C, Mangrella M, Mazzi S, Negrini C, Vaghi A. Treatment of patients with asthma with a fixed combination of budesonide and formoterol: A pharmacoeconomic evaluation versus some therapeutic alternatives. Pharmacoeconomics ‐ Italian Research Articles 2002;4(1):15‐23.
Lötvall 2002 {published data only}
    1. Lötvall J, Woude HJ, Palmqvist M, Arvidsson P, Beckman O, Boorsma M, et al. More rapid onset of action of budesonide/formoterol (Symbicort®) than salmeterol/fluticasone (Seretide™). American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A567.
Magadle 2001 {published data only}
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Malmqvist‐Granlund 2000 {published data only}
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Malolepszy 2002 {published data only}
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McCarthy 2000 {published data only}
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McCarthy 2002 {published data only}
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Mcivor 1998 {published data only}
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Meier 1997 {published data only}
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Meijer 1995 {published data only}
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Michel 2000 {published data only}
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Miraglia del Giudice {published data only}
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Molimard 2001 {published data only}
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Murray 1998 {published data only}
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Nagel 2002 {published data only}
    1. Nagel MW, Wiersema KJ, Bates S L, Mitchell JP. Performance of large‐ and small‐volume valved holding chambers with a new combination long‐term bronchodilator/anti‐inflammatory formulation delivered by pressurized metered dose inhaler. Journal of Aerosol Medicine 2002;15(4):427‐33. - PubMed
Nathan 1998 {published data only}
    1. Nathan RA, Pinnas JL, Schwartz HJ, Grossman J, Yancey SW, Emmett AH, et al. A six‐month, placebo‐controlled comparison of the safety and efficacy of salmeterol or beclomethasone for persistent asthma. Annals of Allergy, Asthma, and Immunology 1999;82:521‐9. - PubMed
Nathan 2001 {published data only}
    1. Nathan RA, Mitchell D, Condemi J, Heller A, Schoaf L, Herrle M, et al. Cardiovascular and hypothalamic‐pituitary‐adrenal axis safety of fluticasone propionate/salmeterol HFA MDI in adolescent and adult patients with asthma. Annual Thoracic Society 97th International Conference; San Francisco CA , May 18‐23. 2001.
    1. Rooklin A, Elkayam D, Weiler J, Windom H, Schoaf L, Scott C, et al. The fluticasone propionate/salmeterol HFA MDI is significantly more efficacious in treating asthma than placebo HFA MDI, fluticasone propionate CFC MDI or salmeterol CFC MDI. Journal of Allergy and Clinical Immunology 2001; Vol. 107, issue 2:s100.
Nelson 1999 {published data only}
    1. Nelson HS, Berkowitz RB, Tinkelman DA, Emmett AH, Rickard KA, Yancey SW. Lack of subsensitivity to albuterol after treatment with salmeterol in patients with asthma . American Journal of Respiratory and Critical Care Medicine 1999;159(5 part 1):1556‐61. - PubMed
Nelson 2000 {published data only}
    1. Nelson H, Chervinsky P, Greos L, Pelskow W, Baitinger L, Scott C, et al. The salmeterol/fluticasone propionate combination product improves asthma control compared with the individual products in asthmatics treated with prn short‐acting beta2‐agonists alone. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue Suppl 3:A196.
    1. Nelson HS, Baitinger L, Scott C, House K, Payne E, Shah T. Salmeterol/fluticasone propionate (50/100µg dose) non‐CFC metered dose inhaler is safe and effective in in patients with asthma using short‐acting ß²‐agonists alone. European Respiratory Journal 2000; Vol. 16, issue 31:53s.
    1. Nelson HS, Busse WW, Kerwin E, Church N, Emmett A, Rickard K, et al. Fluticasone propionate/salmeterol combination provides more effective asthma control than low‐dose inhaled corticosteroid plus montelukast. Journal of Allergy and Clinical Immunology 2000;106(6):1088‐95. - PubMed
    1. Nelson HS, Chervinsky P, Greos L, Pleskow W, Baitinger L, Scott C, et al. The salmeterol/fluticasone propionate combination product improves asthma control compared with the individual products in asthmatics treated with PRN short‐acting beta2‐agonists alone. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue 3 part 2 (Suppl 1):A196.
Nelson 2001 {published data only}
    1. Nelson HS, Nathan RA, Kalberg C, Yancey SW, Rickard KA. Comparison of inhaled salmeterol and oral zafirlukast in asthmatic patients using concomitant inhaled corticosteroids. Medscape General Medicine 2001; Vol. 3, issue 4:3. - PubMed
Nelson 2003 {published data only}
    1. Nelson HS, Wolfe JD, Gross D, Geos LS, Baitinger L, Scott C, et al. Efficacy and safety of fluticasone propionate 44mcg/salmeterol 21mcg administered in a hydrofluoroalkane metered‐dose inhaler as an initial asthma maintenance treatment. Annals of Allergy, Asthma, and Immunology 2003;91:263‐9. - PubMed
    1. Pyke SD, Frith L, Pritchard J, Johnson M, Theophilus A, Shah T. Synergy with salmeterol and fluticasone propionate after administration from a single inhaler (Seretide™). European Respiratory Journal. 2001; Vol. 18, issue Suppl 33:176s.
Newnham 1995 {published data only}
    1. Newnham DM, Grove A, McDevitt DG, Lipworth BJ. Subsensitivity of bronchodilator and systemic beta 2 adrenoceptor responses after regular twice daily treatment with eformoterol dry powder in asthmatic patients. Thorax 1995;50(5):497‐504. - PMC - PubMed
Nielsen 1999 {published data only}
    1. Nielsen LP, Pedersen B, Faurschou P, Madsen F, Wilcke JTR, Dahl R. Salmeterol reduces the need for inhaled corticosteroids in steroid‐dependent asthmatics. Respiratory Medicine 1999;93:863‐68. - PubMed
Nightingale 2002 {published data only}
    1. Nightingale JA, Rogers DF, Barnes PJ. Comparison of the effects of salmeterol and formoterol in patients with severe asthma. Chest 2002;121(5):1401‐6. - PubMed
Norhaya 1999 {published data only}
    1. Norhaya MR, Yap TM, Zainudin BMZ. Addition of inhaled salmeterol to inhaled corticosteroids in patients with poorly controlled nocturnal asthma. Respirology 1999;4:77‐81. - PubMed
Nsouli 2001 {published data only}
    1. Nsouli SM, McNutt WJ. The additive effects of montelukast and salmeterol in moderate asthmatics who are uncontrolled on a low dose on inhaled corticosteroids. Annals of Allergy, Asthma and Immunology 2001;86:81.
O'Brian 2001 {published data only}
    1. O'Brian J, Carlos‐Palma A, Bogolubov M, Davies P, Payne E. Benefits of fluticasone propionate/salmeterol [fp/s] hfa mdi are apparent on the first day of dosing. Annual Thoracic Society 97th International Conference; San Francisco CA ,May 18‐23. 2001.
O'Connor 2002 {published data only}
    1. O'Connor RD, O'Donnell JC, Pinto LA, Wiener DJ, Legorreta AP. Two‐year retrospective economic evaluation of three dual‐controller therapies used in the treatment of asthma. Chest 2002;121(4):1028‐35. - PubMed
Orsida 2001 {published data only}
    1. Orsida BE, Ward C, Li X, Bish R, Wilson JW, Thien F, et al. Effect of a long‐acting beta(2)‐agonist over three months on airway wall vascular remodelling in asthma. American Journal of Respiratory and Critical Care Medicine 2001;164(1):117‐21. - PubMed
Palmer 1992 {published data only}
    1. Palmer JBD, Stuart AM, Shepherd GL, Viskum K. Inhaled salmeterol in the treatment of patients with moderate to severe reversible obstructive airways disease ‐ a 3 month comparison of the efficacy and safety of twice‐daily salmeterol (100 mcg) with salmeterol (50 mcg). Respiratory Medicine 1992;86:409‐17. - PubMed
Palmqvist 2001 {published data only}
    1. Palmqvist M, Arvidsson P, Beckman O, Peterson S, Lotvall J. Onset of bronchodilation of budesonide/formoterol vs salmeterol/fluticasone in single inhalers. Pulmonary Pharmacology & Therapeutics 2001;14(1):29‐34. - PubMed
Paterson 1999 {published data only}
    1. Paterson MC, Wilson AM, Dempsey OJ, Sims EJ, Lipworth BJ. The effect of combination therapy with salmeterol and montelukast in asthmatic patients receiving inhaled corticosteroids. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999:3490.
Pauwels 1998 {published data only}
    1. Pauwel RA, Yernault JC, Demedts MG, Geusens P. Safety and efficacy of fluticasone and beclomethasone in moderate to severe asthma. American Journal of Respiratory & Critical Care Medicine 1998;157(3 part 1):827‐32. - PubMed
Pearlman 1992 {published data only}
    1. Pearlman DA, Chervinsky P, LaForce C, Seltzer JM, Southern DL, Kemp JP, et al. A comparison of salmeterol with albuterol in the treatment of mild to moderate asthma. NEJM 1992;327:1420‐5. - PubMed
Pearlman 1994 {published data only}
    1. Pearlman DS, Liddle R. Controlling asthma symptoms: salmeterol compared with salbutamol in large‐scale multicentre studies. European Respiratory Review 1994;4(21):301‐5.
Pearlman 2001 {published data only}
    1. Pearlman DS, Kent E, Lanz MJ, Peden D, Baitinger L, Herrle M, et al. Fluticasone propionate/salmeterol HFA MDI has a rapid onset of effect in asthmatics treated with short or long‐acting beta2‐agonists (ba) or inhaled corticosteroids. Annual Thoracic Society 97th International Conference; San Francisco CA , May 18‐23. 2001.
Pearlman 2002 {published data only}
    1. Pearlman DS, White MV, Lieberman AK, Pepsin PJ, Kalberg C, Emmett A, et al. Fluticasone propionate/salmeterol combination compared with montelukast for the treatment of persistent asthma. Annals of Allergy, Asthma, and Immunology 2002;88(2):227‐35. - PubMed
Perez 2000 {published data only}
    1. Perez O. Montelukast treatment in children with asthma. Revista Alergia Mexico 2000;47(1):30‐2. - PubMed
Peters 2000 {published data only}
    1. Peters JI, Shelledy DC, Jones AP Jr, Lawson RW, Davis CP, LeGrand TS. A randomized, placebo‐controlled study to evaluate the role of salmeterol in the in‐hospital management of asthma. Chest 2000;118(2):313‐20. - PubMed
Pifferi 2002 {published data only}
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Pinnas 1998 {published data only}
    1. Pinnas JL, Schwartz H, Yancey SW, Rickard K. Six month comparison of beclomethasone vs. salmeterol or placebo in adults with asthma. American Journal of Respiratory and Critical Care Medicine 1998; Vol. 157, issue Suppl 3:A417.
Pizzichini 1996 {published data only}
    1. Pizzichini MM, Kidney JC, Wong BJ, Morris MM, Efthimiadis A, Dolovich J, et al. Effect of salmeterol compared with beclomethasone on allergen‐induced asthmatic and inflammatory responses. European Respiratory Journal 1996;9(3):449‐55. - PubMed
Pljaskic‐Kamenov 2000 {published data only}
    1. Pljaskic‐Kamenov SS, Filipovic MD, Kamenov BA. Comparison of addition of salmeterol xinafoate to budesonide with budesonide alone on symptoms and quality of life in asthmatic children. European Respiratory Journal 2000; Vol. 16, issue Suppl 31:518s.
Pohl 2006 {published data only}
    1. Pohl W, Vetter N, Zwick H, Hrubbs W. Budesonide/formoterol adjustable maintenance dosing (AMD) improves health related quality of life (HRQL) compared with high dose budesonide (AMD) [Abstract]. European Respiratory Journal 2004;24(Suppl 48):311s.
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Pohunek 2006 {published data only}
    1. Pohunek P, Kuna P, Boeck K. Budesonide/formoterol improves lung function compared with budesonide alone in children with asthma [Abstract]. European Respiratory Journal 2004;24(Suppl 48):379s.
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Price 2002 {published data only}
    1. Price D, Dutchman D, Mawson A, Bodalia B, Duggan S, Todd P. FLOW (Eformoterol in the management of mild asthma‐formoterol Turbohaler with budesonide turbohaler) Research group. Thorax 2002;57:791‐8. - PMC - PubMed
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Pujet 1995 {published data only}
    1. Pujet JC, Evano CI. A randomized double‐blind study comparing inhaled beclomethasone with long‐acting theophylline for the first‐line treatment of moderate asthma. Semaine Des Hopitaux. 1995;71(27‐28):865‐72.
Pyke 2001 {published data only}
    1. Pyke SD, Frith L, Pritchard J, Johnson M, Theophilus A, Shah T. Synergy with salmeterol and fluticasone propionate after administration from a single inhaler (Seretide™). European Respiratory Journal. 2001; Vol. 18, issue Suppl 33:176s.
Rance 2002 {published data only}
    1. Rance L, Musin L. Asthma management costs in Canada are lower with combination fluticasone propionate/salmeterol (250/50mcg BID) in as single inhaler than with budesonide 800mcg BID plus eformoterol 12 mcg BID via separate inhalers. Chest (conference); San Diego, CA. 2002:s6.
Remington 2002 {published data only}
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Rickard 1999 {published data only}
    1. Rickard KA, Yancey S, Emmett AH, Kalberg CJ. Salmeterol compared to zafirlukast when added to inhaled corticosteroid therapy in patients with persistent asthma . European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain . 1999:839.
Rickard 2001 {published data only}
    1. Rickard K, Dorinsky PM, Knobil K, Pepsin P, Akveld MLM. The salmeterol/fluticasone propionate combination 50/100µg bid is more effective than oral montelukast 10mg of as a first line therapy in mild and moderate asthmatics. European Respiratory Journal. 2001; Vol. 18, issue Suppl 33:262s.
Rijssenbeek‐Nouwens {published data only}
    1. Rijssenbeek‐Nouwens LHM, Oosting AJ, Monchy JGR, Bregman I, Postma DS, Bruin‐Weller MS. The effect of anti‐allergic mattress encasings on house dust mite‐induced early‐ and late‐airway reactions in asthmatic patients. A double‐blind, placebo‐controlled study. Clinical & Experimental Allergy 2002;32(1):117‐25. - PubMed
Ringbaek 1996 {published data only}
    1. Ringbaek TJ, Soes‐Petersen U, Christensen M, Iversen ET, Rasmussen FV. Salmeterol improves the control of disease in patients with moderate asthma. A comparative study of inhaled salmeterol 50 mg and salbutamol depot tablets 8 mg, both administered twice daily. Ugeskrift for Laeger 1996;158(27):3940‐43. - PubMed
Ringdal 1997 {published data only}
    1. Ringdal N, Eliraz A, Pruzinec R, Weber HH, Mulder PG, Akveld M, et al. The salmeterol/fluticasone combination is more effective than fluticasone plus oral montelukast in asthma. Respiratory Medicine 2003;97(3):234‐4. - PubMed
Ringdal 2002 {published data only}
    1. Alonso JF, Badiola C, Kielhorn A. Economic evaluation of salmeterol/fluticasone combination versus budesonide plus formoterol in Spain. European Respiratory Journal. 2001;18(Suppl 33):49s.
    1. Ringdal N, Chuchalin A, Chovan L, Tudoric N, Maggi E, Whitehead PJ. Evaluation of different inhaled combination therapies (EDICT): a randomised, double‐blind comparison of Seretide (50/250 microg bd Diskus vs. formoterol (12 microg bd) and budesonide (800 microg bd) given concurrently (both via Turbuhaler) in patients with moderate‐to‐severe asthma. Respiratory Medicine 2002;96(11):851‐61. - PubMed
    1. Ringdal N, Chuchalin AG, Chovan L, Whitehead PJ. A comparison of Advair™/Seretide™ (salmeterol 50 mcg/fluticasone propionate 250 mcg bid) with formoterol 12 mcg + budesonide 800 mcg bid in moderate‐severe asthma. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue 3 part 2 (Supp1):A196.
    1. Ringdal NR, Chovan L, Chuchalin AG, Whitehead PJ. Advair™/Seretide™ (250/50mu‐g bid) shows exacerbation benefit over budesonide plus formoterol bid in moderate‐severe asthma. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
Robert 2002 {published data only}
    1. Robert J, Desfougeres JL. Contribution of salmeterol in ambulatory practice to the improvement of asthma and quality of life in childhood. Allergie et Immunologie 2002;34(8):287‐92. - PubMed
Rocca‐Serra 2002 {published data only}
    1. Rocca‐Serra JP, Vicaut E, Lefrancois G, Umile A. Efficacy and tolerability of a new non‐extrafine formulation of beclomethasone HFA‐134a in patients with asthma: comparison with beclomethasone CFC. Clinical Drug Investigation 2002;22(10):653‐65.
Rosenhall 2002 {published data only}
    1. Rosenhall L, Heinig JH, Lindqvist A, Leegaard J, Stahl E, Bergqvist PB. Budesonide/formoterol (Symbicort) is well tolerated and effective in patients with moderate persistent asthma. International Journal of Clinical Practice. 2002;56(6):427‐33. - PubMed
    1. Rosenhall L, Heinig JH, Lindqvist A, Leegard J, Bergqvist PBF. Symbicort (budesonide/eformoterol in a single inhaler) is safe and effective in the treatment of asthma. Thorax 56; Vol. Suppl 3:iii 63.
Rosenhall 2003 {published data only}
    1. Rosenhall L, Elvstrand A, Tilling B, Vinge I, Jemsby P, Stahl E, et al. One‐year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler ) for the treatment of asthma. Respiratory Medicine 2003;97(6):702‐8. - PubMed
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    1. Rosenhall L, Stahl E, Heinig JH, Lindquist A, Leegard J, Bergqvist PBF. Health‐related quality of life and asthma control in patients using Symbicort® (budesonide and formoterol in a single inhaler). Annual Thoracic Society 97th International Conference; San Francisco CA ,May 18‐23. 2001.
    1. Rosenhall L, Stahl E, Heinig JH, Lindqvist A, Leegard J, Bergqvist PBF. Health‐related quality of life and asthma control in patients treated with budesonide and formoterol in a single inhaler. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:46s.
Rosenthal 1999 {published data only}
    1. Rosenthal RR, Busse WW, Kemp JP, Baker JW, Kalberg C, Emmett A, et al. Effect of long‐term salmeterol therapy compared with as‐needed albuterol use on airway hyper‐responsiveness. Chest 1999;116(3):595‐602. - PubMed
Roth 2002 {published data only}
    1. Roth M, Johnson PR, Rudiger JJ, King GG, Ge Q, Burgess JK, et al. Interaction between glucocorticoids and beta2 agonists on bronchial airway smooth muscle cells through synchronised cellular signalling. Lancet 2002;360(9342):1293‐9. - PubMed
Russell 1995 {published data only}
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Saari 2002 {published data only}
    1. Saari SM, Vidgren MT, Herrala J, Turjanmaa VMH, Koskinen MO, Nieminen MM. Possibilities of formoterol to enhanced the peripheral lung deposition of the inhaled liposome corticosteroids. Respiratory Medicine 2002;96(12):999‐1005. - PubMed
SAM40034 {unpublished data only}
    1. Glaxo Smith Kline (SAM40034). A double‐blind, randomised, parallel group, 12‐week comparison of fluticasone propionate/salmeterol combination Diskus 100/50mcg BID with fluticasone propionate (FP) 250mcg BID as initial maintenance treatment in persistent asthma (Seretide Nordic Jump‐Up Study). http://www.ctr.gsk.co.uk 2004.
    1. Kotaniemi J, Tiling B, Oien T. A double‐blind randomised, parallel group study over 12 weeks comparing Seretide (50/100mcg bd Diskus) versus Flixotide ( 250 mcg bd Diskus) as first line regular treatment for steroid‐naive adult patients. American Journal of Respiratory and Critical Care Medicine. 2003; Vol. 167, issue 7:A893.
    1. Oien T, Tilling B, Kontaniemi J. 12 weeks comparing salmeterol/fluticasone propionate (SFC, 50/100mcg bd diskus) versus fluticasone propionate (FP, 250mcg bd diskus) as first‐line regular asthma treatment. European Respiratory Journal 2003;22(Suppl 22):236s.
SAM40036 {unpublished data only}
    1. Glaxo Smith Kline (SAM40036). A 12‐week multicentre, randomised, double‐blind, double‐dummy, parallel group study to compare the efficacy and tolerability of once daily (QD) salmeterol/fluticasone propionate combination (salm/FP) 50/100mcg at night via the DISKUS/ACCUHALER with QD budesonide (BUD) 400mcg at night via a breath‐actuated dry powder inhaler (BADPI) as initial maintenance therapy in mild‐to‐moderate asthmatic subjects. http://www.ctr.gsk.co.uk 2004.
    1. Pauwels R, Smiltena I, Bagdonas A, Eliraz E, Firth R. Seretide once daily is more effective than budesonide 400mcg once daily in mild asthma. American Journal of Respiratory and Critical Care Medicine 2004;169(7):A86.
SAS30015 {published data only}
    1. McCarthy TP, Greening AP, Holgate SK, Whitehead C, Rice L. The efficacy of salmeterol/fluticasone propionate combination (SFC) metered dose inhaler compared with beclomethasone dipropionate (BDP) in patients not well controlled at step 1 of the British guidelines on asthma management (BGAM). Thorax 2001; Vol. 56, issue Suppl 3:iii 62.
    1. McCarthy TP, Russell D, Baxter LE. A comparison of the efficacy of salmeterol/fluticasone propionate combination (SF) with beclometasone dipropionate (BDP) delivered via metered dose inhaler (MDI) in patients not well controlled on bronchodilators alone. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:53‐4s.
    1. SAS30015. A randomised, double‐blind, double‐dummy, cross‐over, repeat dose study to compare the effects of SERETIDE DISKUS (salmeterol/fluticasone propionate combination; 50/250mcg) with co‐administered salmeterol (50mcg) and fluticasone propionate (250mcg) DISKUS on lung function in Japanese and Caucasian asthmatic subjects. http://ctr.gsk.co.uk 2005.
    1. Tolley K, Martin A, Rice L, McCarthy TP. Salmeterol/fluticasone propionate combination (SFC) demonstrates improved health outcomes and good cost effectiveness compared with beclometasone dipropionate. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A112.
Schreurs 1996 {published data only}
    1. Schreurs AJM, Sinninghe Damste HEJ, Graaff CS, Greefhorst APM. A dose‐response study with formoterol Turbuhaler as maintenance therapy in asthmatic patients. European Respiratory Journal 1996;9:1678‐83. - PubMed
Seares 2003 {published data only}
    1. Seares MR, McIvor A, Becker A, Fitzgearld JM, Boulet LP, Ernsy P, et al. Budesonide/formoterol adjustable maintenance dosing effectively improves asthma symptom severity: a multicentre Canadian study. European Respiratory Society. 2003.
Serrier 2003 {published data only}
    1. Serrier P, Roche N, Pello JY, Larguier JS, Mezzi K. Asthma control achieved with inhaled corticosteroids and long‐acting beta2‐agonists in a free or fixed combination: Results of the ALISE survey. Fre. Presse Medicale 2003;32(11):493‐7. - PubMed
Shapiro 2000 {published data only}
    1. Cook CK, Prillaman BA, House KW, Rickard KA, Shah TP. Concurrent use of salmeterol/fluticasone propionate Diskus powder combination product and fluticasone propionate aqueous nasal spray does not adversely affect HPA‐axis function. Annals of Allergy, Asthma and Immunology 2001;86(1):98.
    1. Edin HM, Payne E, Herrle MR, Schoaf L, Mather DB, Scott CA, et al. Salmeterol/fluticasone propionate combination via HFA MDI improves quality of life in asthma patients. Journal of Allergy and Clinical Immunology 2001; Vol. 107, issue 2:s246.
    1. Edin HM, Prillaman B, Baitinger LA, House K, Shah TP. Improved ability to perform strenuous activities after treatment with fluticasone propionate‐salmeterol combination. American Journal of Respiratory and Critical Care Medicine 2002; Vol. 165, issue Suppl 8:A112.
    1. McCarthy TP, Edin HM, House K, Vandermeer AK. Quality of life and asthma control assessment in patients previously on inhaled corticosteroids (ICS) treated with salmeterol/fluticasone combination (SFC) metered dose inhaler (MDI). Thorax 2001; Vol. 56, issue Suppl 3:iii63.
    1. McCarthy TP, Edin HM, House K, Yan SK, Vandermeer AK. The effects of salmeterol/fluticasone combination (SFC) dry powder inhaler (DPI) on asthma control and quality of life in patients previously treated with inhaled corticosteroids (ICS). Thorax 2001; Vol. 56, issue Suppl 3:iii 63.
Shapiro 2001 {published data only}
    1. Shapiro GG, Mendelson LM, Pearlman DS. Once‐daily budesonide inhalation powder (Pulmicort Turbuhaler) maintains pulmonary function and symptoms of asthmatic children previously receiving inhaled corticosteroids. Annals of Allergy, Asthma, and Immunology 2001;86(6):633‐40. - PubMed
Sheth 2002 {published data only}
    1. Sheth K, Borker R, Emmett A, Rickard K, Dorinsky P. Cost‐effectiveness comparison of salmeterol/fluticasone propionate versus montelukast in the treatment of adults with persistent asthma. Pharmacoeconomics 2002;20(13):909‐18. - PubMed
Sienra‐Monge 2001 {published data only}
    1. Sienra‐Monge JJL, Rio BE, Alvarez ME, Magana AJ. Comparison of quality of life and pulmonary function on moderate asthmatic children treated with beclomethasone and beclomethasone plus salmeterol. Journal of Allergy and Clinical Immunology 2001; Vol. 107, issue 2:s263.
Simons 1997 a {published data only}
    1. Simons FE, Gerstner TV, Cheang MS. Tolerance to the broncho‐protective effect of salmeterol in adolescents with exercise‐induced asthma using concurrent inhaled glucocorticoid treatment. Pediatrics 1997;99(5):655‐9. - PubMed
Simons 1997 b {published data only}
    1. Simons FER. A comparison of beclomethasone, salmeterol and placebo in children with asthma. New England Journal of Medicine 1997;337:1659‐65. - PubMed
Sorkness 2007 {published data only}
    1. Sorkness CA, Lemanske Jr RF, Mauger DT, Boehmer SJ, Chinchilli VM, Martinez FD, et al. Long‐term comparison of 3 controller regimens for mild‐moderate persistent childhood asthma: The Pediatric Asthma Controller Trial. Journal of Allergy & Clinical Immunology 2007;119(1):64‐72. - PubMed
Sovani 2008 {published data only}
    1. Sovani MP, Whale CI, Oborne J, Cooper S, Mortimer K, Ekström T, et al. Poor adherence with inhaled corticosteroids for asthma: can using a single inhaler containing budesonide and formoterol help?. The British Journal of General Practice 2008; Vol. 58, issue 546:37‐43. - PMC - PubMed
Staehr 1995 {published data only}
    1. Staehr P, Vestbo I. Salmeterol improves control in asthmatic patients treated in general practice. A comparative study of salmeterol (Serevent) and salbutamol. Ugeskr‐Laeger 1995;157(1):36‐40. - PubMed
Stanford 2002 {published data only}
    1. Stanford RH, Borker R, Dorinsky P, Pepsin P, Kalberg C, Emmett A, et al. The costs and efficacy of fluticasone propionate/salmeterol combination versus montelukast in the treatment of adults with persistent asthma. Chest (conference); San Diego, CA. 2002:422.
Stelmach 2002a {published data only}
    1. Stelmach I, Grzelewski T, Majak P, Majak J, Bobrowska M, Jerzynska J, et al. The effect of triamcinolone, montelukast and formoterol on serum levels of il‐4, IgE and clinical parameters in children with asthma. Polski Merkuriusz Lekarski 2001;11(63):247‐51. - PubMed
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Stelmach 2002b {published data only}
    1. Stelmach I, Jerzynska J, Kuna P. A randomized, double‐blind trial of the effect of glucocorticoid, anti‐leukotriene and [beta]‐agonist treatment on IL‐10 serum levels in children with asthma. Clinical & Experimental Allergy 2002;32(2):264‐9. - PubMed
Stempel 2002 {published data only}
    1. Stempel DA, O'Donnell JC, Meyer JW. Inhaled corticosteroids plus salmeterol or montelukast: effects on resource utilization and costs. Journal of Allergy & Clinical Immunology 2002;109(3):433‐9. - PubMed
Stoloff 2002 {published data only}
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Strand 2003 {published data only}
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Tal 2003 {published data only}
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Thomson 2003 {published data only}
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Tonelli 2001 {published data only}
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Trautmann 2001 {published data only}
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Turner 1998 {published data only}
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Ullman 1990 {published data only}
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Vagaggini 1999 {published data only}
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Van Asperen 2002 {published data only}
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Van den Berg 2000 {published data only}
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Van der Molen 1997a {published data only}
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Van der Woude 2001 {published data only}
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Van Noord 2001 {published data only}
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    1. Noord JA, Lill H, Carrillo T, Davies P. Clinical equivalence of salmeterol/fluticasone propionate combination 50/500 bid delivered via metered dose inhaler (MDI) or Diskus™ in patients with reversible airways obstruction . American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue Suppl 3:A197.
Verberne 1997 {published data only}
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Vestbo 2000 {published data only}
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Vickers 2000 {unpublished data only}
    1. Vickers M. Assessment of long‐term efficacy of early introduction of inhaled steroids in asthma. National Health Technology Assessment (NCCHTA).
Vilsvik 2001 {published data only}
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Von Berg 1989 {published data only}
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Wallaert 1999 {published data only}
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Wallin 1990 {published data only}
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Wallin 2002 {published data only}
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Warner 2001 {published data only}
    1. Warner JO. The role of leukotriene receptor antagonists in the treatment of chronic asthma in childhood. Allergy 2001;56:22‐9. - PubMed
Weersink 1997 {published data only}
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Weinstein 1998 {published data only}
    1. Weinstein SF, Pearlman DS, Bronsky EA, Byrne A, Arledge T, Liddle R, et al. Efficacy of salmeterol xinafoate powder in children with chronic persistent asthma. Annals of Allergy, Asthma, and Immunology 1998;81:51‐8. - PubMed
Weinstein 2001 {published data only}
    1. Weinstein SF, Pearlman DS, Condemi JJ, Herrle MR, Scott CA, Payne JE, et al. Superior efficacy of the fluticasone propionate/salmeterol (88/42mcg) HFA‐MDI combination product versus the individual components in asthmatics previously treated with either short‐ or long‐acting beta2‐agonists or inhaled corticosteroids. Journal of Allergy and Clinical Immunology 2001;107(2):S102.
Wempe 1992 {published data only}
    1. Wempe JB, Tammeling EP, Koeter GH, Hakansson L, Venge P, Postma DS. Blood eosinophil numbers and activity during 24 hours: effects of treatment with budesonide and bambuterol. Journal of Allergy and Clinical Immunology 1992;90(5):757‐65. - PubMed
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Wilding 1997 {published data only}
    1. Wilding P, Clark M, Thompson Coon J, Lewis S, Rushton L, Bennett J, et al. Effect of long term treatment with salmeterol on asthma control: a double‐blind, randomised crossover study. BMJ 1997;314:1441‐6. - PMC - PubMed
Wilson 2001a {published data only}
    1. Dempsey OJ, Wilson AM, Sims EJ, Lipworth BJ. Additive anti‐inflammatory effects of montelukast but not salmeterol in asthmatics suboptimally controlled on inhaled steroids. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue Suppl 3:A198.
    1. Wilson AM, Dempsey OJ, Sims EJ, Lipworth BJ. A comparison of salmeterol and montelukast as second‐line therapy in asthmatic patients not controlled on inhaled corticosteroids. Thorax 1999; Vol. 54, issue Suppl 3 A66:189.
    1. Wilson AM, Dempsey OJ, Sims EJ, Lipworth BJ. Evaluation of salmeterol or montelukast as second‐line therapy for asthma not controlled with inhaled corticosteroids. Chest 2001;119(4):1021‐6. - PubMed
Wilson 2001b {published data only}
    1. Wilson SJ, Wallin A, Della‐Cioppa G, Sandstrom T, Holgate ST. Effects of budesonide and formoterol on NF‐kappaB, adhesion molecules, and cytokines in asthma . American Journal of Respiratory & Critical Care Medicine 2001;164(6):1047‐52. - PubMed
    1. Wilson SJ, Ward JA, Djukanovic R, Wallin A, Sue‐Chu M, Sandstrom T, et al. Effects of high and low dose inhaled fluticasone propionate (FP) compared to low dose FP combined with salmeterol (SAL) on airway inflammation in asthma. American Journal of Respiratory and Critical Care Medicine 2000; Vol. 161, issue Suppl 3:A196.
Wong 1992 {published data only}
    1. Wong BJ, Dolovich J, Ramsdale EH, O'Byrne P, Gontovnick L, Denburg JA, et al. Formoterol compared with beclomethasone and placebo on allergen‐induced asthmatic responses. American Review of Respiratory Disease 1992;146(5 part 1):1156‐60. - PubMed
Woolcock 1995 {published data only}
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Wooltorton 2003 {published data only}
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Yancey 1997 {published data only}
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Yates 1995 {published data only}
    1. Yates DH, Sussman HS, Shaw MJ, Barnes PJ, Chung KF. Regular formoterol treatment in mild asthma: effect on bronchial responsiveness during and after treatment. American Journal of Respiratory and Critical Care Medicine 1995;152(41):1170‐4. - PubMed
Yates 1996 {published data only}
    1. Yates DH, Kharitonov SA, Barnes PJ. An inhaled glucocorticoid does not prevent tolerance to the bronchoprotective effect of a long‐acting inhaled beta 2‐agonist. American Journal of Respiratory & Critical Care Medicine 1996;154(6 part 1):1603‐7. - PubMed
Youngchaiyud 1995 {published data only}
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Yurdakul 2002 {published data only}
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Zarkovic 1998 {published data only}
    1. Zarkovic J, Gotz MH, Holgate ST, Taak NK. Effect of long‐term regular salmeterol treatment in children with moderate asthma. Clinical Drug Investigation 1998;15(3):169‐75.
Zetterstrom 2001 {published data only}
    1. Zetterstrom O, Buhl R, Mellem H. Efficacy and safety of Symbicort® (budesonide and formoterol in a single inhaler) in adults with asthma. Annual Thoracic Society 97th International Conference; San Francisco CA, May 18‐23. 2001.
    1. Zetterstrom O, Buhl R, Mellem H, Perpina M, Hedman J, O'Neill S, et al. The new single inhaler product containing both budesonide/formoterol improves asthma control in adults. European Respiratory Journal 2000; Vol. 16, issue Suppl 31:455s. - PubMed
    1. Zetterstrom O, Buhl R, Perpina M, Hedman J, O'Neill S, Ekstrom T. Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. European Respiratory Journal 2001;18:262‐8. - PubMed
    1. Zetterström O, Buhl R, Mellem H, Perpiñá M, Hedman J, O'Neill S, et al. Efficacy and safety of a new single inhaler product containing both budesonide and formoterol in adult asthma. European Respiratory Journal 2000; Vol. 16, issue 31:455s.
Zhong 2002 {published and unpublished data}
    1. SAM30008. A multi‐centre, randomized, open‐label, parallel‐group, comparison study of the salmeterol/fluticasone propionate combination product via one Diskus/Accuhaler inhaler with salmeterol via one Diskus/Accuhaler inhaler and fluticasone propionate via another Diskus/Accuhaler inhaler in adults with asthma. http://ctr.gsk.co.uk 2005.
    1. Zhong N. Comparison of the effectiveness and safety in use of salmeterol/fluticasone delivered together in a Seretide Acuhaler or salmeterol and fluticasone delivered separately for patients with moderate or severe asthma. Chinese Journal of Tuberculosis and Respiratory Disease 2002;25(6):371.
Zimmerman 2004 {published data only}
    1. Zimmerman B, D'Urzo A, Berube D. Efficacy and safety of formoterol turbuhaler(R) when added to inhaled corticosteroid treatment in children with asthma. Pediatric Pulmonology 2004;37(2):122‐7. - PubMed
    1. Zimmerman B, D'Urzo A, Berube D. Efficacy and tolerability of formoterol Turbuhaler in 6‐11 year old children with asthma, not adequately controlled with inhaled corticosteroids. European Respiratory Society Annual Congress 2002. 2002:P2734.
    1. Zimmerman B, D'Urzo A, Berube D. Efficacy and tolerability of formoterol turbuhaler(r) compared with placebo, in children (6‐11 yr) with asthma poorly controlled with inhaled corticosteroids. American Journal of Respiratory and Critical Care Medicine 2002;165(8 suppl):A746.

References to studies awaiting assessment

Boskovska 2001 {published data only}
    1. Boskovska MI, Dokic D, Busletic‐Bozinovska K, Arbutina S, Goseva Z. Concomitant use of low‐dose inhaled corticosteroids and a long‐acting bronchodilator vis a vis doubling the dose of inhaled corticosteroid in asthma patients. European Respiratory Journal 2001, issue Suppl 33:98s.
Currie 2002 {published data only}
    1. Currie GP, Stenback S Lipworth BJ. Dissociation in effects of fluticasone but not fluticasone/salmeterol on lung function and airway hyperresponsiveness in mild persistent asthma. European Respiratory Society Annual Congress. 2002:385s.
Djordjevic 1999 {published data only}
    1. Djordjevic D, Zickovic D, Stankovic I, Pejcic T, Ducic J, Rancic M, et al. Comparative study of three months treatment in combination of salmeterol and beclomethasone dipropionate (bdp) with doubling the dose of bdp in mild asthma. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999:849.
Ozkaya 1999 {published data only}
    1. Ozkaya O, Turktas I, Cengizlier R. Low dose budesonide plus formoterol versus high dose budesonide in children with bronchial asthma. European Respiratory Society; 1999 Oct 9‐13; Madrid, Spain. 1999:P365.
Stankovic 2000 {published data only}
    1. Stankovic IJ, Djordjevic DV, Pejcic TA, Zivkovic DS, Rancic MR, Ristic LM, et al. Formoterol and beclomethasone dipropionate versus higher dose beclomethasone dipropionate in asthma patients. European Respiratory Journal 2000;16(Suppl 31):455s.
Stojkovic‐Andjelkovi 2001 {published data only}
    1. Stojkovic‐Andjelkovic AK, Pajovic DM, Protrka OJ, Ugrinovic BS, Obradovic SM, Pavicevic MD. Effect of combination fluticasone propionate and salmeterol diskhaler in treatment of moderate to severe asthma: comparison of initial high dose, constant medium dose and placebo. European Respiratory Journal 2001; Vol. 18, issue Suppl 33:123s.
VIAPAED 102318 {unpublished data only}
    1. GlaxoSmithKline (VIAPAED 102318). Steroid‐sparing with the salmeterol/fluticasone propionate 50/100 mcg b.i.d. combination compared to fluticasone propionate 200mcg b.i.d. alone in the management of children and adolescents with moderate persistent asthma. http://www.gsk‐clinicalstudyregister.com (accessed 29 October 2008) 2008.
Zharov 2004 {published data only}
    1. Zaharov T, Kamenov SS, Kamenov BA. Improvements in FEV and PEF were greater with salmeterol/fluticasone (S/F) than with beclomethasone dipropionate (BDP). European Respiratory Journal 2004;24(Suppl 48):380s.
    1. Zhaharov TV, Kamenov SS, Kamenov BA. Improvements in FEV and PEF were greater with salmeterol/fluticasone (S/F) than with beclomethasone dipropionate (BDP). European Respiratory Journal 2004;24(Suppl 48):379s.

References to ongoing studies

Aziz {published data only}
    1. Aziz I. Comparison of anti inflammatory effect of once daily inhaled formoterol and once daily inhaled budesonide on inflammatory markers in asthmatic patients . Clinical Pharmacology, Ninewells Hospital and Medical School, University of Dundee, DUNDEE, DD1 9SY, Scotland UK.
Barnes a {published data only}
    1. Barnes NC. A randomized parallel 3 arm study to assess asthma control, lung function, costs and quality of life in patients with asthma treated with formoterol twice daily and either budesonide once or twice daily from a novel multidisc dry powder inhaler. Respiratory Medicine, London Chest Hospital, Bonner Road, London, E2 9JX, United Kingdom.
Barnes b {published data only}
    1. Barnes PJ. Effect of low dose formoterol and budesonide on exhaled breath in asthma. Royal Brompton and Harefield NHS Trust.
Bush {published data only}
    1. Bush A. Efficacy and safety of budesonide/formoterol Turbuhaler , compared to budesonide turbuhaler metered dose, in steroid using asthmatic adolescent patients, double blind, double dummy parallel group, Phase III, multicentre study. Department of Paediatrics, Imperial College School of Medicine, Brompton Campus, Dovehouse Street, London, SW3 6LY, United Kingdom). Royal Brompton and Harefield NHS Trust.
Currie {published data only}
    1. Currie GP. Are there additional anti‐inflammatory effects of leukotriene receptor antagonists in persistent asthmatics receiving inhaled steroid alone and combined inhaled steroid/long acting B2‐agonists?. Academic Publications.
Goves {published data only}
    1. Goves JR. Eformoterol in the management of mild asthma ‐ eformoterol Turbohaler R with budesonide Turbohaler R. Department of Paediatrics, Level 4 John Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU.
Hill {published data only}
    1. Hill J. The ASSURE Study ‐ the effectiveness and safety of an individualised Symbicort Turbohaler maintenance dosing regimen (Symbicort Asthma Control Plan) versus Symbicort Turbohaler given as standard regular twice daily therapy.
Kharitonov {published data only}
    1. Kharitonov SA. Effect of inhaled corticosteroids (budesonide 100 micrograms/400 micrograms vs placebo) and formoterol on localisation of glucocorticoid receptor and exhaled markers in asthma. Royal Brompton and Harefield NHS Trust.
Lipworth 2001 {unpublished data only}
    1. Lipworth BJ. Relative lung bioavailability with fluticasone via dry powder inhaler versus: (a) fluticasone/salmeterol combination vis dry powder inhaler; (b) fluticasone/salmeterol combination via HFA‐pMDI plus spacer, in patients with moderate persistent asthma. Academic publications 2001; Vol. June.
Millar {published data only}
    1. Millar AB. A randomised double‐blind multi‐centre study to evaluate the effect of adding alternative agents to inhaled steroids in adult asthmatics. (Telephone: 0117 9595348). South West Regional Office, North Bristol NHS Trust. Lung Research Unit, Southmead Hospital, Southmead Road, Westbury‐on‐Trym, Bristol, BS10 5NB, UK.
Ruggins {published data only}
    1. Ruggins N. Pragmatic trial of add‐on therapy in paediatric asthma. Southern Derbyshire Acute Hospitals NHS Trust.
Thomson {published data only}
    1. Thomson NC. Budesonide/formoterol fixed combination in adults with asthma. Respiratory Medicine, Gartnavel General Hospital, Great Western Road, Glasgow, G12 0YN, Scotland.
Young {published data only}
    1. Young KM. St Mary's Surgery, 37 St Mary's Street, Ely, Cambs, CB7 4HF.

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