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Meta-Analysis
. 2013 Aug 30;2013(8):CD006826.
doi: 10.1002/14651858.CD006826.pub2.

Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus inhaled corticosteroids alone for chronic obstructive pulmonary disease

Luis Javier Nannini  1 , Phillippa Poole, Stephen J Milan, Annabel Kesterton
Affiliations
Meta-Analysis

Combined corticosteroid and long-acting beta(2)-agonist in one inhaler versus inhaled corticosteroids alone for chronic obstructive pulmonary disease

Luis Javier Nannini et al. Cochrane Database Syst Rev. .

Abstract

Background: Both long-acting beta(2)-agonists and inhaled corticosteroids have been recommended in guidelines for the treatment of chronic obstructive pulmonary disease (COPD). Their co-administration in a combined inhaler is intended to facilitate adherence to medication regimens and to improve efficacy. Three preparations are currently available: fluticasone propionate/salmeterol (FPS). budesonide/formoterol (BDF) and mometasone furoate/formoterol (MF/F).

Objectives: To assess the efficacy and safety of combined long-acting beta2-agonist and inhaled corticosteroid (LABA/ICS) preparations, as measured by clinical endpoints and pulmonary function testing, compared with inhaled corticosteroids (ICS) alone, in the treatment of adults with chronic obstructive pulmonary disease (COPD).

Search methods: We searched the Cochrane Airways Group Specialised Register of trials, which is compiled from systematic searches of multiple literature databases. The search was conducted in June 2013. In addition, we checked the reference lists of included studies and contacted the relevant manufacturers.

Selection criteria: Studies were included if they were randomised and double-blind. Compared studies combined LABA/ICS with the ICS component.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. The primary outcomes were exacerbations, mortality and pneumonia. Health-related quality of life (as measured by validated scales), lung function and side effects were secondary outcomes. Dichotomous data were analysed as fixed-effect odds ratios with 95% confidence intervals (CIs), and continuous data as mean differences or rate ratios and 95% CIs.

Main results: A total of 15 studies of good methodological quality met the inclusion criteria by randomly assigning 7814 participants with predominantly poorly reversible, severe COPD. Data were most plentiful for the FPS combination. Exacerbation rates were significantly reduced with combination therapies (rate ratio 0.87, 95% CI 0.80 to 0.94, 6 studies, N = 5601) compared with ICS alone. The mean exacerbation rate in the control (ICS) arms of the six included studies was 1.21 exacerbations per participant per year (range 0.88 to 1.60), and we would expect this to be reduced to a rate of 1.05 (95% CI 0.97 to 1.14) among those given combination therapy. Mortality was also lower with the combination (odds ratio (OR) 0.78, 95% CI 0.64 to 0.94, 12 studies, N = 7518) than with ICS alone, but this was heavily weighted by a three-year study of FPS. When this study was removed, no significant mortality difference was noted. The reduction in exacerbations did not translate into significantly reduced rates of hospitalisation due to COPD exacerbation (OR 0.93, 95% CI 0.80 to 1.07, 10 studies, N = 7060). Lung function data favoured combination treatment in the FPS, BDF and MF/F trials, but the improvement was small. Small improvements in health-related quality of life were measured on the St George's Respiratory Questionnaire (SGRQ) with FPS or BDF compared with ICS, but this was well below the minimum clinically important difference. Adverse event profiles were similar between the two treatments arms, and rates of pneumonia when it was diagnosed by chest x-ray (CXR) were lower than those reported in earlier trials.

Authors' conclusions: Combination ICS and LABA offer some clinical benefits in COPD compared with ICS alone, especially for reduction in exacerbations. This review does not support the use of ICS alone when LABAs are available. Adverse events were not significantly different between treatments. Further long-term assessments using practical outcomes of current and new 24-hour LABAs will help determine their efficacy and safety. For robust comparisons as to their relative effects, long-term head-to-head comparisons are needed.

PubMed Disclaimer

Conflict of interest statement

The review authors who have been involved in this review have done so with no known conflicts of interest. None of the authors is considered a paid consultant by any pharmaceutical company that produces agents discussed in this review.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 All Combined Inhalers－Primary Outcomes, outcome: 1.1 Exacerbation rates (exacerbations requiring oral corticosteroids).
4
4
Forest plot of comparison: 1 All Combined Inhalers－Primary Outcomes, outcome: 1.2 Number of participants with one or more exacerbation.
5
5
Forest plot of comparison: 1 All Combined Inhalers－Primary Outcomes, outcome: 1.3 Hospitalisations due to COPD exacerbations.
6
6
Forest plot of comparison: 1 All Combined Inhalers－Primary Outcomes, outcome: 1.4 Mortality.
7
7
Forest plot of comparison: 1 All Combined Inhalers－Primary Outcomes, outcome: 1.5 Pneumonia.
8
8
Funnel plot of comparison: 1 All Combined Inhalers－Primary Outcomes, outcome: 1.4 Mortality.
1.1
1.1. Analysis
Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 1 Exacerbation rates (exacerbations requiring oral corticosteroids).
1.2
1.2. Analysis
Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 2 Number of participants with one or more exacerbation.
1.3
1.3. Analysis
Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 3 Hospitalisations due to COPD exacerbations.
1.4
1.4. Analysis
Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 4 Mortality.
1.5
1.5. Analysis
Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 5 Pneumonia.
2.1
2.1. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 1 Exacerbation rates.
2.2
2.2. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 2 Number of participants with one or more exacerbation.
2.3
2.3. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 3 End of treatment mean number of exacerbations per participant.
2.4
2.4. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 4 Number of participants with one or more exacerbations by type.
2.5
2.5. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 5 Exacerbations by type.
2.6
2.6. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 6 Mortality.
2.7
2.7. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 7 Mortality－cause specific.
2.8
2.8. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 8 Change from baseline in St George's Respiratory Questionnaire (total score).
2.9
2.9. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 9 Change from baseline in Transitional Dyspnoea Index (TDI).
2.10
2.10. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 10 Change from baseline in Chronic Respiratory Disease Questionnaire scores.
2.11
2.11. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 11 Change from baseline in predose FEV1.
2.12
2.12. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 12 Change from baseline in post‐dose FEV1.
2.13
2.13. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 13 End of treatment am PEF (L/min).
2.14
2.14. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 14 Absolute shuttle walk test.
2.15
2.15. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 15 Change from baseline in rescue medication usage (puffs/d).
2.16
2.16. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 16 Withdrawals.
2.17
2.17. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 17 Withdrawal due to lack of efficacy/exacerbation.
2.18
2.18. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 18 Withdrawals due to adverse events.
2.19
2.19. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 19 Adverse events－any event.
2.20
2.20. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 20 Adverse events－serious.
2.21
2.21. Analysis
Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 21 Adverse events (specific adverse events).
3.1
3.1. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 1 Exacerbations.
3.2
3.2. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 2 Mean exacerbation rates per participant per year.
3.3
3.3. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 3 Mortality.
3.4
3.4. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 4 Quality of life－SGRQ total (change scores).
3.5
3.5. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 5 Symptoms (change scores).
3.6
3.6. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 6 Breathlessness, cough and sputum score (BCSS) change from baseline－average over treatment period.
3.7
3.7. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 7 Awakening‐free nights, percentage change from baseline.
3.8
3.8. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 8 Mean FEV1 (% increase from baseline).
3.9
3.9. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 9 Pre‐dose FEV1 [L] change from baseline to the average over the randomised treatment period.
3.10
3.10. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 10 1‐Hour post‐dose FEV1 [L] change from baseline to the average over the randomised treatment period.
3.11
3.11. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 11 Morning PEFR change from baseline, average over treatment period (L/min).
3.12
3.12. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 12 Evening PEFR mean change from baseline, average over treatment period (L/min).
3.13
3.13. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 13 Rescue medication use.
3.14
3.14. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 14 Sleep score (0 to 4)－change from baseline.
3.15
3.15. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 15 Dyspnoea score (0 to 4)－change from baseline.
3.16
3.16. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 16 Cough score (0 to 4)－change from baseline.
3.17
3.17. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 17 Sputum score (0 to 4)－change from baseline.
3.18
3.18. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 18 Withdrawals due to worsening COPD symptoms.
3.19
3.19. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 19 Withdrawals due to adverse events.
3.20
3.20. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 20 Adverse event－any (one or more).
3.21
3.21. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 21 Adverse events－serious events.
3.22
3.22. Analysis
Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 22 Adverse events (specific adverse events).
4.1
4.1. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 1 Patients with one or more exacerbation.
4.2
4.2. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 2 Mortality.
4.3
4.3. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 3 Change from baseline in SGRQ (total score).
4.4
4.4. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 4 Change from baseline in FEV1 AUC0‐12 h (mL) week 26.
4.5
4.5. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 5 Change from baseline in FEV1 AUC0‐12 h (mL) week 13.
4.6
4.6. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 6 Mean change from baseline AM pre‐dose FEV1 at 13 weeks (mL).
4.7
4.7. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 7 Withdrawals－total.
4.8
4.8. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 8 Withdrawals due to adverse event.
4.9
4.9. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 9 Withdrawal due to treatment failure.
4.10
4.10. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 10 Adverse event－any.
4.11
4.11. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 11 Adverse event－serious.
4.12
4.12. Analysis
Comparison 4 Mometasone/formoterol (MF/F) versus Mometasone (MF), Outcome 12 Adverse events (specific adverse events).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Bourbeau 2007 {published data only}
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    1. Borgstrom L, Asking L, Olsson H, Peterson S. Lack of interaction between disease severity and therapeutic response with budesonide/formoterol in a single inhaler [Abstract]. American Thoracic Society 100th International Conference; May 21‐26; 2004, Orlando, Florida. C22 [Poster 505].
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Doherty 2012 {published data only}
    1. Doherty DE, Kerwin E, Tashkin DP, Matiz‐Bueno CE, Shekar T, Banerjee S, et al. Combined mometasone furoate and formoterol in patients with moderate to very severe chronic obstructive pulmonary disease (COPD): phase 3 efficacy and safety study [Abstract]. Journal of Allergy and Clinical Immunology 2012; Vol. 129, issue 2 Suppl:AB75 [283].
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Hanania 2003 {published and unpublished data}
    1. Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, et al. The efficacy and safety of fluticasone propionate (250 micro g)/salmeterol (50 micro g) combined in the diskus inhaler for the treatment of COPD. Chest 2003;124(3):834‐43. - PubMed
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    1. Horstman D, Darken P, Davis S, Lee B. Improvements in FEV1 and symptoms in poorly reversible COPD patients following treatment with salmeterol 50mcg/fluticasone propionate 250mcg combination [Abstract]. European Respiratory Journal 2003;22 Suppl 45:P434.
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Lapperre 2009 {published data only}
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Mahler 2002 {published and unpublished data}
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    1. SFCA3006. A randomized, double‐blind, placebo‐controlled, parallel‐group trial evaluating the safety and efficacy of the DISKUS formulations of salmeterol (SAL) 50mcg BID and fluticasone propionate (FP) 500mcg BID individually and in combination as salmeterol 50mcg/fluticasone propionate 500mcg BID (SFC 50/500) compared to placebo in COPD subjects. GlaxoSmithKline Clinical Trials Register (http:ctr.gsk.co.uk) 2005.
    1. Spencer M, Wire P, Lee B, Chang CN, Darken P, Horstman D. Patients with COPD using salmeterol/fluticasone propionate combination therapy experience improved quality of life. European Respiratory Journal 2003;22 Suppl 45:51s.
    1. Spencer MD, Anderson JA. Salmeterol/fluticasone combination produces clinically important benefits in dyspnea and fatigue [Abstract]. American Thoracic Society 2005 International Conference; May 20‐25, 2005; San Diego, California. B93 [Poster 308].
NCT00358358 {published data only}
    1. NCT00358358. Trial SCO104925. See detailed description, 2006. http://clinicaltrials.gov/show/NCT00358358. []
SFCT01 {unpublished data only}
    1. SFCT01. A Multicentre, Randomised, Double‐Blind, Parallel Group, Placebo‐Controlled Study to Compare the Efficacy and Safety of Inhaled Salmeterol/Fluticasone Propionate Combination Product 25/250 µg Two Puffs Bd and Fluticasone Propionate 250µg Two Puffs Bd Alone, All Administered Via Metered Dose Inhalers (MDI), in the Treatment of Subjects with Chronic Obstructive Pulmonary Disease (COPD) for 52 Weeks. GlaxoSmithKline Clinical Trials Register (http:ctr.gsk.co.uk) 2005.
Sin 2008 {published data only}
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Szafranski 2003 {published and unpublished data}
    1. Anderson P. Budesonide/formoterol in a single inhaler (Symbicort) provides early and sustained improvement in lung function in moderate to severe COPD [Abstract]. Thorax 2002;57(Suppl III):iii43.
    1. AstraZeneca SD. A placebo‐controlled 12 month efficacy study of the fixed combination budesonide/formoterol compared with budesonide and formoterol as monotherapies in patients with chronic obstructive pulmonary disease (COPD). AstraZeneca Clinical Trials 2001.
    1. Borgstrom L, Asking L, Olsson H, Peterson S. Lack of interaction between disease severity and therapeutic response with budesonide/formoterol in a single inhaler [Abstract]. American Thoracic Society 100th International Conference; May 21‐26, 2004; Orlando, Florida. C22 [Poster 505].
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Tashkin 2008 {published data only}
    1. Astrazeneca (D5899C00002). A 6‐month double‐blind, double‐dummy, randomized, parallel group, multicenter efficacy & safety study of Symbicort® pMDI 2 × 160/4.5mg & 80/4.5mg bid compared to Formoterol TBH, Budesonide pMDI (& the combination) & placebo in COPD patients. www.astrazenecaclinicaltrials.com (accessed 8 April 2008).
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    1. NCT00383435. A Randomized, 26‐Week, Placebo‐Controlled Efficacy and Safety Study With a 26‐Week Long‐Term Safety Extension, of High‐ and Medium‐Dose Inhaled Mometasone Furoate/Formoterol Fixed‐Dose Combination Formulation Compared With Formoterol and High‐Dose Inhaled Mometasone Furoate Monotherapy in Subjects With Moderate to Severe COPD, 2006. http://clinicaltrials.gov/show/NCT00383435. []
    1. Tashkin DP, Doherty DE, Kerwin E, Matiz‐Bueno CE, Knorr B, Shekar T, et al. Efficacy and safety of a fixed‐dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52‐week Phase III trial. International Journal of Chronic Obstructive Pulmonary Disease 2012; Vol. 7, issue 1178‐2005 (Electronic). 1176‐9106 (Linking):43‐55. - PMC - PubMed
TORCH {published and unpublished data}
    1. Briggs AH, Glick HA, Lozano‐Ortega G, Spencer M, Calverley PM, Jones PW, et al. Is treatment with ICS and LABA cost‐effective for COPD? Multinational economic analysis of the TORCH study. European Respiratory Journal 2010; Vol. 35, issue 3:532‐9. - PubMed
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TRISTAN {published and unpublished data}
    1. Calverley P, Pauwels R, Vestbo J, Jones P, Pride N, Gulsvik A, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003;361(9356):449‐56. - PubMed
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    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. Proceedings of the 98th International American Thoracic Society Conference http://www.abstracts‐on‐line.com/abstracts/ATS; May 17‐22, 2002; Atlanta, Georgia. A98 [Poster 306].
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    1. Hunjan MK, Chandler F. Numbers needed to treat (NNT) to avoid an exacerbation in patients with chronic obstructive pulmonary disease (COPD) using salmeterol/fluticasone propionate combination (SFC) and associated costs [Abstract]. American Thoracic Society 100th International Conference; May 21‐26, 2004; Orlando, Florida. D22 [Poster 503].
Zhong 2012 {published data only}
    1. Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, et al. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Current Medical Research and Opinion 2012; Vol. 28, issue 2:257‐65. - PubMed
    1. Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, et al. Efficacy and safety of inhalation of budesonide/formoterol via turbuhaler in Chinese patients with chronic obstructive pulmonary disease [Abstract]. Chest 2011; Vol. 140, issue 4:5225A.

References to studies excluded from this review

Aaron 2007 {published data only}
    1. Aaron SD, Vandemheen KL, Fergusson D, Maltais F, Bourbeau J, Goldstein R, et al. Tiotropium in combination with placebo, salmeterol, or fluticasone‐salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial.[see comment]. Annals of Internal Medicine 2007; Vol. 146, issue 8:545‐55. - PubMed
Bathoorn 2008 {published data only}
    1. Bathoorn E, Liesker JJ, Postma DS, Boorsma M, Bondesson E, Koëter GH, et al. Anti‐inflammatory effects of combined budesonide/formoterol in COPD exacerbations. COPD 2008; Vol. 5, issue 5:282‐90. - PubMed
Bleecker 2011 {published data only}
    1. Bleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, et al. Effect of β2‐adrenergic receptor gene polymorphism Gly16Arg on response to budesonide/formoterol pressurized metered‐dose inhaler In chronic obstructive pulmonary disease [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011; Vol. 183, issue Meeting Abstracts:A4086.
Calverley 2005 {published data only}
    1. Calverley PM, Szafranski W, Andersson A. Budesonide/formoterol is a well‐tolerated long term maintenance therapy for COPD [Abstract]. European Respiratory Journal 2005; Vol. 26 Suppl 49:Abstract No. 1917.
Cukier 2007 {published data only}
    1. Cukier A, Ferreira CAS, Stelmach R, Ribeiro M, Cortopassi F, Calverley PMA. The effect of bronchodilators and oxygen alone and in combination on self‐paced exercise performance in stable COPD. Respiratory Medicine 2007;101(4):743‐53. - PubMed
D5899C00001 {published data only}
    1. A 12‐Month Double‐blind, Double‐dummy, Randomized, Parallel‐group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 × 160/4.5 mcg bid and 2 × 80/4.5mcg bid Compared to Formoterol TBH 2 × 4.5 mcg bid and Placebo in Patients with COPD. AstraZeneca 2008.
De Backer 2011 {published data only}
    1. Backer L, Backer J, Vos W, Holsbeke C, Vinchurkar S, Backer W. Double blind, placebo controlled crossover study in COPD patients to assess the acute effect of budesonide/formoterol using HRCT and lung function tests [Abstract]. European Respiratory Society Annual Congress; September 24‐28, 2011; Amsterdam, The Netherlands Vol. 38, issue 55:600s [P3362].
Ferguson 2006 {published data only}
    1. Ferguson GT. Cardiovascular safety of simultaneous therapy with Advair and Combivent in the treatment of COPD [Abstract]. Proceedings of the American Thoracic Society; June 15, 2006; San Diego, California A109 [Poster J2].
GlaxoSmithKline 2004 {published data only}
    1. GlaxoSmithKline SAS40007. A Randomised, Double‐Blind, Double‐Dummy, Parallel‐Group Comparison of SERETIDE DISKUS/ACCUHALER (50/100 µg Strength) twice daily (bid) with Budesonide 400 µg bid in Adolescents and Adults with Reversible Airways Obstruction. http://ctr.gsk.co.uk/Summary/fluticasone_salmeterol/IV_SAS40007.pdf. GlaxoSmithKline Clinical Trial Register, 2004.
GlaxoSmithKline 2004a {published data only}
    1. GlaxoSmithKline SAS40006. A Randomised, Double‐Blind, Double‐Dummy, Parallel‐Group Comparison of Seretide DISKUS/ACCUHALER (50/250g Strength) b.i.d. with Budesonide 800g b.i.d. in Adolescents and Adults with Reversible Airways Obstruction. http://ctr.gsk.co.uk/Summary/fluticasone_salmeterol/IV_SAS40006.pdf. GlaxoSmithKline Clinical Trial Register, 2004.
GlaxoSmithKline 2006 {published data only}
    1. GlaxoSmithKline SCO30005. A 13‐Week, Double‐Blind, Parallel‐Group, Multicentre Study to Compare the Bronchial Anti‐inflammatory Activity of the Combination of Salmeterol/ Fluticasone Propionate (SERETIDE™/ADVAIR™/VIANI™) 50/500 mcg Twice Daily Compared With Placebo Twice Daily in Patients With Chronic Obstructive Pulmonary Disease. GlaxoSmithKline Clinical Trial Register, 2006.
Golabi 2006 {published data only}
    1. Golabi P, Topaloglu N, Karakurt S, Celikel T. Effects of tiotropium and salmeterol/fluticasone combination on lung hyperinflation dyspnea and exercise tolerance in COPD [Abstract]. European Respiratory Journal 2006;28(Suppl 50):33s.
Haque 2006 {published data only}
    1. Haque RA, Torrego A, Essilfie‐Quaye S, Kharitonov SA, Johnson M, Adcock IM, et al. Effect of salmeterol and fluticasone on glucocorticoid receptor translocation in sputum macrophages and peripheral blood mononuclear cells from patients with chronic obstructive pulmonary disease. Proceedings of the American Thoracic Society; May 23‐26, 2006; San Diego, California. A848.
INSPIRE {published data only}
    1. GlaxoSmithKline (SCO40036). Multicentre, randomised, double‐blind, double‐dummy, parallel group, 104‐week study to compare the effect of the salmeterol/fluticasone propionate combination product (SERETIDE*) 50/500mcg delivered twice daily via the DISKUS*/ACCUHALER* inhaler with tiotropium bromide 18 mcg delivered once daily via the HandiHaler inhalation device on the rate of health care utilisation exacerbations in subjects with severe chronic obstructive pulmonary disease (COPD). http://ctr.gsk.co.uk (accessed 8 April 2008).
    1. Seemungal T, Stockley R, Calverley P, Hagan G, Wedzicha JA. Investigating new standards for prophylaxis in reduction of exacerbations－the INSPIRE study methodology. Journal of Chronic Obstructive Pulmonary Disease 2007;4(3):177‐83. - PubMed
    1. Wedzicha J, Stockley R, Seemungal T, Hagan G, Calverley P. The INSPIRE study: effect of salmeterol/fluticasone propionate versus tiotropium bromide on COPD exacerbations. Respirology 2007;12(Suppl 4):A112.
Jiang 2011 {published data only}
    1. Jiang YP, Zhao YF, Yang Y. Effect of seretide on quality of life in COPD: measured with COPD assessment test [Abstract]. Respirology (Carlton, Vic.) 2011; Vol. 16, issue Suppl 2:100 [344].
Jung 2012 {published data only}
    1. Jung KS, Park HY, Park SY, Kim SK, Kim YK, Shim JJ, et al. Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study. Respiratory Medicine 2012; Vol. 106, issue 3:382‐9. - PubMed
Laties 2010 {published data only}
    1. Laties A, Rennard SI, Tashkin DP, Suchower LJ, Martin UJ. Effect of budesonide/formoterol pressurized metered‐dose inhaler (bud/fm pmdi) on ophthalmologic assessments in moderate to very severe chronic obstructive pulmonary disease (COPD) patients: results from a 1‐year, randomized, controlled clinical trial [Abstract]. Chest 2010; Vol. 138, issue 4:468A.
Lindberg 2007 {published data only}
    1. Lindberg A, Szalai Z, Pullerits T, Radeczky E. Fast onset of effect of budesonide/formoterol versus salmeterol/fluticasone and salbutamol in patients with chronic obstructive pulmonary disease and reversible airway obstruction. Respirology (Carlton, Vic.) 2007; Vol. 12, issue 5:732‐9. - PubMed
Mittmann 2010 {published data only}
    1. Mittmann N, Hernandez P, Mellsträm C, Brannman L, Welte T, Mellström C, et al. Cost‐effectiveness of budesonide/formoterol added to tiotropium in COPD patients in Canada, Australia and Sweden [Abstract]. European Respiratory Society Annual Congress; September 18‐22, 2010; Barcelona, Spain [5183].
Mittmann 2011 {published data only}
    1. Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. PharmacoEconomics 2011; Vol. 29, issue 5:403‐14. - PubMed
NCT00269126 {published data only}
    1. NCT00269126. See detailed description, 2005. http://clinicaltrials.gov/show/NCT00269126. []
NCT00476099 {published data only}
    1. NCT00476099. A 48‐Week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3‐Arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA‐134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD), 2006. http://clinicaltrials.gov/show/NCT00476099. []
NCT00549146 {published data only}
    1. NCT00549146. Trial: SCO40055, 2003. http://clinicaltrials.gov/show/NCT00549146. []
Rennard 2008 {published data only}
    1. Rennard SI, Tashkin DP, McElhattan J, Goldman M, Silkoff PE. Long‐term tolerability of budesonide and formoterol administered in one pressurized metered‐dose inhaler in patients with moderate to very severe chronic obstructive pulmonary disease [Abstract]. Chest 2008; Vol. 134, issue 4:103003s.
Rennard 2009 {published data only}
    1. Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered‐dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1‐year randomized controlled clinical trial. Drugs. Adis Data Information BV., 2009; Vol. 69, issue 0012‐6667:549‐65. - PMC - PubMed
Rennard 2009a {published data only}
    1. Rennard SI, Tashkin DP, McElhattan J, Goldman M, Ramachandran S, Martin UJ, et al. Efficacy and tolerability of budesonide/formoterol in one hydrofluoroalkane pressurized metered‐dose inhaler in patients with chronic obstructive pulmonary disease: results from a 1‐year randomized controlled clinical trial. Drugs 2009;69:549‐65. - PMC - PubMed
Rennard 2010 {published data only}
    1. Rennard SI, Tashkin DP, Suchower LJ, Martin UJ. Effect of budesonide/formoterol pressurized metered‐dose inhaler (BUD/FM pMDI) on bone mineral density (BMD) in moderate to very severe chronic obstructive pulmonary disease (COPD) patients: results from a 1‐year, randomized, controlled clinical trial [Abstract]. Chest 2010; Vol. 138, issue 4:863A.
Sagcan 2007 {published data only}
    1. Sagcan G, Memis U, Cuhadaroglu C, Sen C, Duygu E. The effects of formoterol/budesonide on sleep quality of COPD patients [Abstract]. European Respiratory Journal 2007; Vol. 30, issue Suppl 51:507s [E3049].
Schermer 2007 {published data only}
    1. Schermer TR, Albers JM, Verblackt HW, Costongs RJ, Westers P. Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. Family Practice 2007; Vol. 24, issue 2:181‐8. - PubMed
SCO100250 {unpublished data only}
    1. GlaxoSmithKline (SCO100250). A randomized, double‐blind, parallel‐group, 52‐week study to compare the effect of fluticasone propionate/salmeterol DISKUS 250/50mcg bid with salmeterol DISKUS 50mcg bid on the annual rate of moderate/severe exacerbations in subjects with chronic obstructive pulmonary disease (COPD). http://ctr.gsk.co.uk (accessed 8 April 2008).
SCO40043 {unpublished data only}
    1. SCO40043. A randomized, double‐blind, parallel‐group, 52‐week study to compare the effect of fluticasone propionate/salmeterol DISKUS® 250/50mcg bid with salmeterol DISKUS® 50mcg bid on the annual rate of moderate/severe exacerbations in subjects with chronic obstructive pulmonary disease (COPD). http://ctr.gsk.co.uk (accessed 8 April 2008).
Sethi 2006 {published data only}
    1. Sethi S, Grove L, Wrona C, Maloney J. Prevalence of bacterial colonization in COPD is not altered by fluticasone/salmeterol. Proceedings of the American Thoracic Society; May 23‐26. 2006; San Diego, California. A115.
Shaker 2009 {published data only}
    1. Shaker SB, Dirksen A, Ulrik CS, Hestad M, Stavngaard T, Laursen LC, et al. The effect of inhaled corticosteroids on the development of emphysema in smokers assessed by annual computed tomography. COPD 2009; Vol. 6, issue 2:104‐11. - PubMed
Sharafkhaneh 2011 {published data only}
    1. Sharafkhaneh A, Southard J, Goldman M, Uryniak T, Martin UJ. Long‐term effect of budesonide/formoterol pressurized metered‐dose inhaler on exacerbations and pulmonary function in patients with chronic obstructive pulmonary disease [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011; Vol. 183, issue Meeting Abstracts:A1599.
Southard 2011 {published data only}
    1. Southard JG, Sharafkhaneh A, Goldman M, Uryniak T, Martin UJ. Long‐term tolerability of budesonide/formoterol pressurized metered‐dose inhaler In patients with chronic obstructive pulmonary disease and a history of exacerbations [Abstract]. American Journal of Respiratory and Critical Care Medicine 2011; Vol. 183, issue Meeting Abstracts:A1597.
Stallberg 2008 {published data only}
    1. Stallberg B, Andersson EBC, Ekstrom T, Selroos O, Vogelmeier C, Larsson K. Budesonide /formoterol for the treatment of COPD exacerbations in the primary healthcare setting [Abstract]. European Respiratory Society Annual Congress; October 4‐8, 2008; Berlin, Germany [P3610].
Sutherland 2006 {published data only}
    1. Sutherland ER, Moss TA, Stevens AD, Pak J, Martin RJ. Modulation of sputum gene expression in COPD by fluticasone /salmeterol. European Respiratory Journal 2006;28(Suppl 50):662s.
Trofimenko 2006 {published data only}
    1. Trofimenko IN, Chernyak BA. The efficacy of salmeterol/fluticasone (SF) for 6 month's therapy at severe COPD patients. European Respiratory Journal 2006;28(Suppl 50):30s.
Welte 2009 {published data only}
    1. Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 2009; Vol. 180, issue 8:741‐50. - PubMed
Welte 2009a {published data only}
    1. Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Addition of budesonide/formoterol to tiotropium reduces the number of exacerbation days compared with tiotropium alone [Abstract]. Chest 2009; Vol. 136, issue 4:26S‐f.
Welte 2009b {published data only}
    1. Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, et al. Budesonide/formoterol added to tiotropium provides rapid improvements in lung function and ability to undertake morning activities [Abstract]. Chest 2009; Vol. 136, issue 4:24S‐g.
Welte 2009c {published data only}
    1. Welte T, Hartman L, Polanowski T, Hernandez P, Miravitlles M, Peterson S, et al. Budesonide/formoterol added to tiotropium is well tolerated and reduces risk of severe exacerbations in COPD patients [Abstract]. American Thoracic Society International Conference; May 15‐20, 2009; San Diego, California A6188 [Poster #215].
Welte 2009d {published data only}
    1. Welte T, Miravitlles M, Hernandez P, Peterson S, Polanowski T, Kessler R, et al. Budesonide/formoterol added to tiotropium improves exacerbations and exacerbation‐related antibiotic use in patients with COPD [Abstract]. European Respiratory Society Annual Congress; September 12‐16, 2009; Vienna, Austria [P2012].
Wilson 2007 {published data only}
    1. Wilson DS, Gillion MS, Rees PJ. Use of dry powder inhalers in COPD. International Journal of Clinical Practice 2007; Vol. 61, issue 12:2005‐8. - PubMed
Worth 2009 {published data only}
    1. Worth H, Foerster K, Peterson S, Nihlen U, Magnussen H, et al. Budesonide/formoterol improves exercise tolerance compared with placebo and formoterol in COPD patients [Abstract]. European Respiratory Society Annual Congress; September 12‐16, 2009; Vienna, Austria [201].
Worth 2009a {published data only}
    1. Worth H, Peterson S, Nihlen U, Magnussen H. Improved exercise tolerance with budesonide/formoterol vs placebo and formoterol in COPD patients [Abstract]. American Thoracic Society International Conference; May 15‐20, 2009; San Diego, California A6193 [Poster #220].
Worth 2010 {published data only}
    1. Worth H, Förster K, Eriksson G, Nihlén U, Peterson S, Magnussen H. Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD. Respiratory Medicine 2010; Vol. 104, issue 10:1450‐9. - PubMed
Zheng 2006 {published data only}
    1. Zheng J, Zhong N, Yang L, Wu Y, Chen P, Wen Z, et al. The efficacy and safety of fluticasone propionate 500 mg/salmeterol 50 mg combined via diskus/accuhaler in Chinese patients with chronic obstructive pulmonary disease (COPD). Chest 2006;130(4):182s.
    1. Zhong N, Zheng J, Yang L, Wu Y, Chen P, Wen Z, et al. The efficacy and safety of salmeterol 50µg/fluticasone propionate 500µg combined via accuhaler in Chinese patients with chronic obstructive pulmonary disease [Abstract]. Respirology 2006;11(Suppl 5):A150.

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References to other published versions of this review

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