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Meta-Analysis
. 2007 Jan 24;2007(1):CD001385.
doi: 10.1002/14651858.CD001385.pub2.

Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid

E H Walters  1 , P G Gibson, T J Lasserson, J A E Walters
Affiliations
Meta-Analysis

Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid

E H Walters et al. Cochrane Database Syst Rev. .

Abstract

Background: Asthma is a common respiratory disease among both adults and children and short acting inhaled beta-2 agonists are used widely for 'reliever' bronchodilator therapy. Long acting beta-2 agonists (LABA) were introduced as prospective 'symptom controllers' in addition to inhaled corticosteroid 'preventer' therapy (ICS). In this updated review we have included studies in which patients were either not on ICS as a group, or in which some patients, but not all, were on ICS to complement previous systematic reviews of studies where LABA was given in patients uniformly receiving ICS. We have focussed particularly on serious adverse events, given previous concerns about potential risks, especially of death, from regular beta-2 agonist use.

Objectives: This review aimed to determine the benefit or detriment on the primary outcome of asthma control with the regular use of LABA compared with placebo, in mixed populations in which only some were taking ICS and in populations not using ICS therapy.

Search strategy: We carried out searches using the Cochrane Airways Group trial register, most recently in October 2005. We searched bibliographies of identified RCTs for additional relevant RCTs and contacted authors of identified RCTs for other published and unpublished studies.

Selection criteria: All randomised studies of at least four weeks duration, comparing a LABA given twice daily with a placebo, in chronic asthma. Selection criteria to this updated review have been altered to accommodate recently published Cochrane reviews on combination and addition of LABA to ICS therapy. Studies in which all individuals were uniformly taking ICS were excluded from this review.

Data collection and analysis: Two reviewers performed data extraction and study quality assessment independently. We contacted authors of studies for missing data.

Main results: Sixty-seven studies (representing 68 experimental comparisons) randomising 42,333 participants met the inclusion criteria. Salmeterol was used as long-acting agent in 50 studies and formoterol fumarate in 17. The treatment period was four to nine weeks in 29 studies, and 12 to 52 weeks in 38 studies. Twenty-four studies did not permit the use of ICS, and forty permitted either inhaled corticosteroid or cromones (in three studies this was unclear). In these studies between 22% and 92% were taking ICS, with a median of 62%. There were significant advantages to LABA treatment compared to placebo for a variety of measurements of airway calibre including morning peak expiratory flow (PEF), evening PEF and FEV1. They were associated with significantly fewer symptoms, less use of rescue medication and higher quality of life scores. This was true whether patients were taking LABA in combination with ICS or not. Findings from SMART (a recently published surveillance study) indicated significant increases in asthma related deaths, respiratory related deaths and combined asthma related deaths and life threatening experiences. The absolute increase in asthma-related mortality was consistent with an increase of around one per 1250 patients treated with LABA for six months, but the confidence intervals are wide (from 700 to 10,000). Post-hoc exploratory subgroups suggested that African-Americans and those not on inhaled corticosteroids were at particular risk for the primary end-point of death or life-threatening asthma event. There was also a suggestion of an increase in exacerbation rate in children. Pharmacologically predicted side effects such as headache, throat irritation, tremor and nervousness were more frequent with LABA treatment.

Authors' conclusions: LABA are effective in the control of chronic asthma in the "real-life" subject groups included. However there are potential safety issues which call into question the safety of LABA, particularly in those asthmatics who are not taking ICS, and it is not clear why African-Americans were found to have significant differences in comparison to Caucasians for combined respiratory-related death and life threatening experiences, but not for asthma-related death.

PubMed Disclaimer

Conflict of interest statement

E H Walters has taken part in collaborative clinical pharmacology studies with a number of pharmaceutical companies including GSK, Astra Zeneca, Pfizer, Boehringer, Schering Plough, SKB, and Novartis. He has, in the past, held consultancies with GSK, Pfizer and Zeneca. He has had sponsorship to meetings from a number of the companies listed over the past 15 years. PG Gibson has taken part in collaborative clinical studies with a number of pharmaceutical companies including GSK, AstraZeneca, Boerhinger Ingelheim, and Aventis. He has attended meetings sponsored by a number of companies.

Figures

1.1
1.1. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 1 Peak expiratory flow: morning.
1.2
1.2. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 2 Peak expiratory flow: evening.
1.3
1.3. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 3 Change in PEF morning.
1.4
1.4. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 4 Change in PEF morning (%).
1.5
1.5. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 5 Change in PEF evening.
1.6
1.6. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 6 N with >/=15% increase in FEV1.
1.7
1.7. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 7 Change in PEF morning ‐percent predicted.
1.8
1.8. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 8 Change in PEF evening‐percent predicted.
1.9
1.9. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 9 Amplitude PEF: diurnal variation (l/min or %).
1.10
1.10. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 10 N with >/=15% increase in PEF.
1.11
1.11. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 11 Change in peak expiratory flow: % predicted.
1.12
1.12. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 12 Peak expiratory flow: % predicted.
1.13
1.13. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 13 AUC‐ mean area under 12 hr serial PEF curve (% predicted).
1.14
1.14. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 14 Change in Amplitude PEF: diurnal variation (l/min or %).
1.15
1.15. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 15 FEV1.
1.16
1.16. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 16 FEV1 predicted.
1.17
1.17. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 17 Change in FEV (litres).
1.18
1.18. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 18 N with >/=15% increase in FEV1.
1.19
1.19. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 19 AUC‐ mean area under 12 hr serial FEV1 curve.
1.20
1.20. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 20 Change in FEV1 %predicted.
1.21
1.21. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 21 AUC‐ mean area under 12 hr serial FEV1 curve (% predicted).
1.22
1.22. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 22 AUC‐ mean change area under 12 hr serial FEV1 curve (L‐h).
1.23
1.23. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 23 Fall in FEV1 post exercise (12 hrs post study drug) %.
1.24
1.24. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 24 Fall in FEV1 post exercise (pre‐medication with formoterol) %.
1.25
1.25. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 25 FEV1 12hr post dose.
1.26
1.26. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 26 Change in FEV1 12hr post dose.
1.27
1.27. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 27 Forced Vital Capacity (litres).
1.28
1.28. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 28 Change in Forced Vital Capacity (litres).
1.29
1.29. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 29 FEF25‐75 (litres/sec).
1.30
1.30. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 30 Symptom score ‐ whole day.
1.31
1.31. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 31 Symptom score ‐ day time.
1.32
1.32. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 32 Symptom score ‐ night time.
1.33
1.33. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 33 Change in symptom score: whole day.
1.34
1.34. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 34 Change in symptom score: day time.
1.35
1.35. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 35 Change in symptom score: night time.
1.36
1.36. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 36 Change in total symptom score.
1.37
1.37. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 37 % days without rescue medication.
1.38
1.38. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 38 N with <50% days free from rescue medication.
1.39
1.39. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 39 % days without asthma symptoms.
1.40
1.40. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 40 N with <50% symptom free days.
1.41
1.41. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 41 % nighttime awakenings requiring no SABA.
1.42
1.42. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 42 Change in nighttime awakenings.
1.43
1.43. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 43 N with <50% symptom free nights.
1.44
1.44. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 44 Change in % no nighttime awakenings.
1.45
1.45. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 45 % nights without asthma awakenings.
1.46
1.46. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 46 Change in % nighttime awakenings requiring no SABA.
1.47
1.47. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 47 N with <50% nights free from rescue medication.
1.48
1.48. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 48 Change in % days without asthma symptoms.
1.49
1.49. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 49 Change in % nights without asthma symptoms.
1.50
1.50. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 50 Rescue bronchodilator use: whole day.
1.51
1.51. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 51 Rescue bronchodilator use: day time.
1.52
1.52. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 52 Rescue bronchodilator use: night time.
1.53
1.53. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 53 Change in use of rescue bronchodilator/day.
1.54
1.54. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 54 Change in use of rescue bronchodilator/night.
1.55
1.55. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 55 Change in use of rescue bronchodilator/ whole day.
1.56
1.56. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 56 Change in % days without rescue medication.
1.57
1.57. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 57 AQOL‐ Change in Quality of life score: global.
1.58
1.58. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 58 Change in Quality of life score‐ symptoms.
1.59
1.59. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 59 Change in Quality of life score: emotions.
1.60
1.60. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 60 Change in Quality of life score: exposure to environmental stimuli.
1.61
1.61. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 61 Change in Quality of life score: activity limitations.
1.62
1.62. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 62 Mini AQLQ (Total).
1.63
1.63. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 63 Mini AQLQ (Symptoms).
1.64
1.64. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 64 Mini AQLQ (Activity limitation).
1.65
1.65. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 65 Mini AQLQ (Emotional function).
1.66
1.66. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 66 Mini AQLQ (Environmental stimuli).
1.67
1.67. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 67 Quality of life score: COMBINED ALL SCALES.
1.68
1.68. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 68 Bronchial hyperreactivity‐ log PD20/PC20 methacholine or histamine.
1.69
1.69. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 69 Bronchial hyperreactivity‐ log PD20/PC20 methacholine or histamine.
1.70
1.70. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 70 Change in BHR (end treatment vs. baseline)‐ doubling doses (DD).
1.71
1.71. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 71 Bronchoprotection to methacholine challenge(protection ratio end treatment vs. baseline)‐ doubling doses (DD).
1.72
1.72. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 72 Bronchoprotection to methacholine challenge (protection ratio first dose treatment vs. baseline)‐ double dose.
1.73
1.73. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 73 Exacerbations asthma ‐ >1 major.
1.74
1.74. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 74 Exacerbations asthma ‐ >1 major(sub‐group by use of inhaled corticosteroid).
1.75
1.75. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 75 Weaned from at least 1 non steroidal asthma medication.
1.76
1.76. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 76 Global assessment of efficacy by patient‐ very good/good.
1.77
1.77. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 77 Global assessment of efficacy by investigator‐ very good/good.
1.78
1.78. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 78 Global assessment of efficacy by patient ‐ improved.
1.79
1.79. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 79 Global assessment of efficacy by patient ‐ not improved.
1.80
1.80. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 80 Global assessment of efficacy by investigator ‐ improved.
1.81
1.81. Analysis
Comparison 1 Studies with parallel group design: efficacy outcomes, Outcome 81 Global assessment of efficacy by investigator ‐ not improved.
2.1
2.1. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 1 Death (asthma related) subgrouped by ICS at baseline.
2.2
2.2. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 2 Death (asthma related) subgrouped Caucasians and African Americans.
2.3
2.3. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 3 Death (respiratory related).
2.4
2.4. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 4 Death (all cause) ‐ SMART non‐ICS subgroup.
2.5
2.5. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 5 Death (all cause) ‐ SMART all participants.
2.6
2.6. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 6 SMART primary endpoint subgroups (Caucasians and African Americans).
2.7
2.7. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 7 Serious adverse event ‐ life threatening adverse events.
2.8
2.8. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 8 Serious adverse event ‐ asthma related.
2.9
2.9. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 9 Serious adverse event related to study drug ‐ total.
2.10
2.10. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 10 Withdrawals (all reasons).
2.11
2.11. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 11 Withdrawals (adverse events).
2.12
2.12. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 12 Withdrawals (asthma‐related adverse events).
2.13
2.13. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 13 Withdrawals (abnormal cadiovascular test).
2.14
2.14. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 14 Withdrawals (lack of efficacy).
2.15
2.15. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 15 Withdrawals (exacerbation of asthma).
2.16
2.16. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 16 Adverse events ‐ total.
2.17
2.17. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 17 Adverse events ‐ any drug related.
2.18
2.18. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 18 Adverse events ‐ asthma related.
2.19
2.19. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 19 Adverse events ‐ pharyngitis.
2.20
2.20. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 20 Adverse events ‐ cough.
2.21
2.21. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 21 Adverse events ‐ nasopharyngitis.
2.22
2.22. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 22 Adverse events ‐ throat irritation.
2.23
2.23. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 23 Adverse events ‐ upper respiratory tract infection.
2.24
2.24. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 24 Adverse events ‐ dyspnea.
2.25
2.25. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 25 Adverse events ‐ exacerbation of asthma.
2.26
2.26. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 26 Adverse events ‐ otitis media.
2.27
2.27. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 27 Adverse events ‐ sinus headache.
2.28
2.28. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 28 Adverse events ‐ pyrexia.
2.29
2.29. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 29 Adverse events ‐ chest pain.
2.30
2.30. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 30 Adverse events ‐ abnormal cardiovascular test.
2.31
2.31. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 31 Adverse events ‐ palpitations.
2.32
2.32. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 32 Adverse events ‐ insomnia.
2.33
2.33. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 33 Adverse events ‐ tremor.
2.34
2.34. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 34 Adverse events ‐ headache.
2.35
2.35. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 35 Adverse events ‐ cramps.
2.36
2.36. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 36 Adverse events ‐ anxiety.
2.37
2.37. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 37 Adverse events ‐ nervousness.
2.38
2.38. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 38 Adverse events ‐ nausea.
2.39
2.39. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 39 Adverse events ‐ myalgia/fatigue.
2.40
2.40. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 40 Adverse events ‐ pain in limb.
2.41
2.41. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 41 Adverse events ‐ musculoskeletal pain.
2.42
2.42. Analysis
Comparison 2 Studies with parallel group design: withdrawal & safety outcomes, Outcome 42 Serious adverse event ‐ respiratory.
3.1
3.1. Analysis
Comparison 3 Studies by severity of asthma, Outcome 1 Peak expiratory flow: morning.
3.2
3.2. Analysis
Comparison 3 Studies by severity of asthma, Outcome 2 Peak expiratory flow: evening.
3.3
3.3. Analysis
Comparison 3 Studies by severity of asthma, Outcome 3 Change in PEF morning.
3.4
3.4. Analysis
Comparison 3 Studies by severity of asthma, Outcome 4 Change in PEF evening.
3.5
3.5. Analysis
Comparison 3 Studies by severity of asthma, Outcome 5 Amplitude PEF: diurnal variation (l/min or %).
3.6
3.6. Analysis
Comparison 3 Studies by severity of asthma, Outcome 6 Change in Amplitude PEF: diurnal variation (l/min or %).
3.7
3.7. Analysis
Comparison 3 Studies by severity of asthma, Outcome 7 FEV1.
3.8
3.8. Analysis
Comparison 3 Studies by severity of asthma, Outcome 8 FEV1 predicted.
3.9
3.9. Analysis
Comparison 3 Studies by severity of asthma, Outcome 9 Change in FEV (litres).
3.10
3.10. Analysis
Comparison 3 Studies by severity of asthma, Outcome 10 Change in FEV %predicted.
3.11
3.11. Analysis
Comparison 3 Studies by severity of asthma, Outcome 11 Forced Vital Capacity (litres).
3.12
3.12. Analysis
Comparison 3 Studies by severity of asthma, Outcome 12 Change in Forced Vital Capacity (litres).
3.13
3.13. Analysis
Comparison 3 Studies by severity of asthma, Outcome 13 FEF25‐75 (litres/sec).
3.14
3.14. Analysis
Comparison 3 Studies by severity of asthma, Outcome 14 Symptom score‐ whole day.
3.15
3.15. Analysis
Comparison 3 Studies by severity of asthma, Outcome 15 Symptom score ‐ day time.
3.16
3.16. Analysis
Comparison 3 Studies by severity of asthma, Outcome 16 Symptom score ‐ night time.
3.17
3.17. Analysis
Comparison 3 Studies by severity of asthma, Outcome 17 Change in symptom score ‐ day time.
3.18
3.18. Analysis
Comparison 3 Studies by severity of asthma, Outcome 18 Change in symptom score ‐ night time.
3.19
3.19. Analysis
Comparison 3 Studies by severity of asthma, Outcome 19 %days without asthma symptoms.
3.20
3.20. Analysis
Comparison 3 Studies by severity of asthma, Outcome 20 % nights without asthma awakenings.
3.21
3.21. Analysis
Comparison 3 Studies by severity of asthma, Outcome 21 Change in %days without asthma symptoms.
3.22
3.22. Analysis
Comparison 3 Studies by severity of asthma, Outcome 22 Change in % nights without asthma symptoms.
3.23
3.23. Analysis
Comparison 3 Studies by severity of asthma, Outcome 23 Rescue bronchodilator use: whole day.
3.24
3.24. Analysis
Comparison 3 Studies by severity of asthma, Outcome 24 Rescue bronchodilator use: day time.
3.25
3.25. Analysis
Comparison 3 Studies by severity of asthma, Outcome 25 Rescue bronchodilator use: night time.
3.26
3.26. Analysis
Comparison 3 Studies by severity of asthma, Outcome 26 Change in use of rescue bronchodilator/day.
3.27
3.27. Analysis
Comparison 3 Studies by severity of asthma, Outcome 27 Change in use of rescue bronchodilator/night.
3.28
3.28. Analysis
Comparison 3 Studies by severity of asthma, Outcome 28 Change in use of rescue bronchodilator/ whole day.
3.29
3.29. Analysis
Comparison 3 Studies by severity of asthma, Outcome 29 AQOL‐ Change in Quality of life score: global.
3.30
3.30. Analysis
Comparison 3 Studies by severity of asthma, Outcome 30 Change in Quality of life score‐ symptoms.
3.31
3.31. Analysis
Comparison 3 Studies by severity of asthma, Outcome 31 Change in Quality of life score: emotions.
3.32
3.32. Analysis
Comparison 3 Studies by severity of asthma, Outcome 32 Change in Quality of life score: exposure to environmental stimuli.
3.33
3.33. Analysis
Comparison 3 Studies by severity of asthma, Outcome 33 Change in Quality of life score: activity limitations.
3.34
3.34. Analysis
Comparison 3 Studies by severity of asthma, Outcome 34 Bronchial hyperreactivity‐ log PD20/PC20 methacholine or histamine.
3.36
3.36. Analysis
Comparison 3 Studies by severity of asthma, Outcome 36 Exacerbations asthma (all)‐ >1 major.
3.37
3.37. Analysis
Comparison 3 Studies by severity of asthma, Outcome 37 Global assessment of efficacy by patient‐ very good/good.
4.1
4.1. Analysis
Comparison 4 Studies with crossover design, Outcome 1 Peak expiratory flow: morning.
4.2
4.2. Analysis
Comparison 4 Studies with crossover design, Outcome 2 Peak expiratory flow: evening.
4.3
4.3. Analysis
Comparison 4 Studies with crossover design, Outcome 3 Change in PEF morning predicted.
4.4
4.4. Analysis
Comparison 4 Studies with crossover design, Outcome 4 Change in PEF evening predicted.
4.5
4.5. Analysis
Comparison 4 Studies with crossover design, Outcome 5 Change in PEF morning.
4.6
4.6. Analysis
Comparison 4 Studies with crossover design, Outcome 6 Change in PEF evening.
4.7
4.7. Analysis
Comparison 4 Studies with crossover design, Outcome 7 Amplitude PEF: diurnal variation (l/min or %).
4.9
4.9. Analysis
Comparison 4 Studies with crossover design, Outcome 9 FEV1.
4.10
4.10. Analysis
Comparison 4 Studies with crossover design, Outcome 10 Predicted FEV1.
4.11
4.11. Analysis
Comparison 4 Studies with crossover design, Outcome 11 PD20 treatment ratio.
4.12
4.12. Analysis
Comparison 4 Studies with crossover design, Outcome 12 Forced Vital Capacity (litres).
4.13
4.13. Analysis
Comparison 4 Studies with crossover design, Outcome 13 Change in symptom score‐ day time.
4.14
4.14. Analysis
Comparison 4 Studies with crossover design, Outcome 14 Change in symptom score‐ night time.
4.15
4.15. Analysis
Comparison 4 Studies with crossover design, Outcome 15 Days without asthma symptoms.
4.16
4.16. Analysis
Comparison 4 Studies with crossover design, Outcome 16 Nights without asthma awakenings.
4.17
4.17. Analysis
Comparison 4 Studies with crossover design, Outcome 17 Rescue bronchodilator use: whole day.
4.18
4.18. Analysis
Comparison 4 Studies with crossover design, Outcome 18 Change in use of rescue bronchodilator/day.
4.19
4.19. Analysis
Comparison 4 Studies with crossover design, Outcome 19 Change in use of rescue bronchodilator/night.
4.20
4.20. Analysis
Comparison 4 Studies with crossover design, Outcome 20 Bronchial hyperreactivity‐ log PD20/PC20 methacholine or histamine.
4.21
4.21. Analysis
Comparison 4 Studies with crossover design, Outcome 21 Change in BHR (end treatment vs. baseline)‐ doubling doses (DD).
4.22
4.22. Analysis
Comparison 4 Studies with crossover design, Outcome 22 Bronchoprotection to methacholine challenge(protection ratio end treatment vs. baseline)‐ doubling doses (DD).
4.23
4.23. Analysis
Comparison 4 Studies with crossover design, Outcome 23 Bronchoprotection to methacholine challenge(protection ratio first dose treatment vs. baseline)‐ DD.
4.24
4.24. Analysis
Comparison 4 Studies with crossover design, Outcome 24 Bronchodilator response to eformoterol (delta peak FEV1).
4.25
4.25. Analysis
Comparison 4 Studies with crossover design, Outcome 25 Adverse events‐ total adverse events.
4.26
4.26. Analysis
Comparison 4 Studies with crossover design, Outcome 26 Days with no rescue medication usage.
4.27
4.27. Analysis
Comparison 4 Studies with crossover design, Outcome 27 Adverse events‐ headache.
4.28
4.28. Analysis
Comparison 4 Studies with crossover design, Outcome 28 Adverse events‐ tremor.
4.29
4.29. Analysis
Comparison 4 Studies with crossover design, Outcome 29 Adverse events‐ cough.
4.30
4.30. Analysis
Comparison 4 Studies with crossover design, Outcome 30 Exacerbations asthma‐ >1 major(sub‐group by use of inhaled corticosteroid).
4.31
4.31. Analysis
Comparison 4 Studies with crossover design, Outcome 31 Rate of exacerbations asthma (number/patient/year).
4.32
4.32. Analysis
Comparison 4 Studies with crossover design, Outcome 32 Adverse events ‐ upper respiratory tract infection.
4.33
4.33. Analysis
Comparison 4 Studies with crossover design, Outcome 33 Adverse events ‐ musculoskeletal pain.
4.34
4.34. Analysis
Comparison 4 Studies with crossover design, Outcome 34 Global assessment of efficacy by patient‐ very good/good.
4.35
4.35. Analysis
Comparison 4 Studies with crossover design, Outcome 35 Global assessment of efficacy by investigator‐ very good/good.
4.36
4.36. Analysis
Comparison 4 Studies with crossover design, Outcome 36 Adverse events ‐ throat irritation.
4.37
4.37. Analysis
Comparison 4 Studies with crossover design, Outcome 37 Rescue medication usage (blisters).
4.38
4.38. Analysis
Comparison 4 Studies with crossover design, Outcome 38 Fall in FEV1post exercise(6‐9 hrs post study drug) % or % predicted.
4.39
4.39. Analysis
Comparison 4 Studies with crossover design, Outcome 39 Nights without symptoms.
4.40
4.40. Analysis
Comparison 4 Studies with crossover design, Outcome 40 Change from baseline PD15.
5.1
5.1. Analysis
Comparison 5 Imputed standard deviations, Outcome 1 Change in PEF morning.
5.2
5.2. Analysis
Comparison 5 Imputed standard deviations, Outcome 2 Peak expiratory flow: morning.
5.3
5.3. Analysis
Comparison 5 Imputed standard deviations, Outcome 3 FEV1.
5.4
5.4. Analysis
Comparison 5 Imputed standard deviations, Outcome 4 Change in PEF evening.
5.5
5.5. Analysis
Comparison 5 Imputed standard deviations, Outcome 5 Change in FEV (litres).
5.6
5.6. Analysis
Comparison 5 Imputed standard deviations, Outcome 6 Change in FEV %predicted.
5.7
5.7. Analysis
Comparison 5 Imputed standard deviations, Outcome 7 Change in % days without asthma symptoms.
5.8
5.8. Analysis
Comparison 5 Imputed standard deviations, Outcome 8 Change in % nights without asthma symptoms.
5.9
5.9. Analysis
Comparison 5 Imputed standard deviations, Outcome 9 Change in use of rescue bronchodilator/day.
5.10
5.10. Analysis
Comparison 5 Imputed standard deviations, Outcome 10 Peak expiratory flow: evening l/min.
5.11
5.11. Analysis
Comparison 5 Imputed standard deviations, Outcome 11 Rescue bronchodilator use: whole day.
5.12
5.12. Analysis
Comparison 5 Imputed standard deviations, Outcome 12 Change in use of rescue bronchodilator/night.
5.13
5.13. Analysis
Comparison 5 Imputed standard deviations, Outcome 13 Change in use of rescue bronchodilator/ whole day.
5.14
5.14. Analysis
Comparison 5 Imputed standard deviations, Outcome 14 FEV1 predicted.
5.15
5.15. Analysis
Comparison 5 Imputed standard deviations, Outcome 15 Peak expiratory flow: evening.
5.16
5.16. Analysis
Comparison 5 Imputed standard deviations, Outcome 16 AQOL‐ Change in Quality of life score: global.
5.17
5.17. Analysis
Comparison 5 Imputed standard deviations, Outcome 17 % nights without asthma awakenings.
6.1
6.1. Analysis
Comparison 6 WMD archive, Outcome 1 Peak expiratory flow: morning l/min.
6.2
6.2. Analysis
Comparison 6 WMD archive, Outcome 2 FEV1 (litres).
6.3
6.3. Analysis
Comparison 6 WMD archive, Outcome 3 Peak expiratory flow: evening l/min.
6.4
6.4. Analysis
Comparison 6 WMD archive, Outcome 4 Bronchial hyperreactivity‐ log PD20/PC20 methacholine or histamine.
6.5
6.5. Analysis
Comparison 6 WMD archive, Outcome 5 % Predicted FEV1.
6.6
6.6. Analysis
Comparison 6 WMD archive, Outcome 6 Change in PEF morning (l/min).
6.7
6.7. Analysis
Comparison 6 WMD archive, Outcome 7 Change in PEF evening (l/min).
6.8
6.8. Analysis
Comparison 6 WMD archive, Outcome 8 Peak expiratory flow: morning l/min (crossover studies).
6.9
6.9. Analysis
Comparison 6 WMD archive, Outcome 9 Peak expiratory flow: evening l/min (crossover studies).
6.10
6.10. Analysis
Comparison 6 WMD archive, Outcome 10 FEV1 (litres; crossover studies).
6.11
6.11. Analysis
Comparison 6 WMD archive, Outcome 11 AUC‐ mean area under 12 hr serial FEV1 curve (L‐h).
6.12
6.12. Analysis
Comparison 6 WMD archive, Outcome 12 Mini‐AQLQ (total score).
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References

References to studies included in this review

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D'Alonzo 1994 {published data only}
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Dahl 1991a {published data only}
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Dahl 1991b {published data only}
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Ekstrom 1998a {published data only}
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Ekstrom 1998b {published data only}
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Garcia 2001 {published data only}
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Hyland 1994 {published data only}
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Jones 1994 {published data only}
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Kavuru 2000a {published data only}
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Kemp 1998a {published data only}
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Kemp 1999 {published data only}
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Kraft 1997 {published data only}
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Lindqvist 2003 {published and unpublished data}
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Nathan 1999 {published data only}
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Nelson 1998 {published data only}
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Nelson 1999b {published data only}
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Newnham 1994 {published data only}
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Pearlman 1992 {published data only}
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    1. Pearlman DS. Long‐acting beta 2‐agonist salmeterol compared with albuterol in maintenance asthma therapy. Annals of Allergy Asthma & Immunology 1995;75(2):180‐4. - PubMed
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Pearlman 1999a {published data only}
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Pleskow 2003 {published data only}
    1. FORNDA 20831_41. A twelve week, double‐blind, parallel group trial comparing the safety, tolerability and efficacy of formoterol dry powder capsules for inhalation delivered by a single‐dose inhaler versus albuterol metered dose inhaler device versus placebo in patients with mild to moderate asthma. www.fda.gov 2001.
    1. Mann M, Chowdhury B, Sullivan E, Nicklas R, Anthracite R, Meyer RJ. Serious asthma exacerbations in asthmatics treated with high‐dose formoterol. Chest 2003;124(1):70‐4. - PubMed
    1. Pleskow W, LaForce C, Yegen Ü, Matos D, Della Cioppa G. Formoterol Delivered via the Dry Powder Aerolizer® Inhaler Versus Albuterol MDI and Placebo in Mild‐to‐Moderate Asthma: A Randomized, Double‐Blind, Double‐Dummy Trial. Journal of Asthma 2003;40(5):505‐14. - PubMed
Prieto 2002 {published data only}
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Ramage 1994 {published data only}
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    1. Ramage L, Lipworth BJ, Ingram CG, et al. Reduced protection against exercise induced bronchoconstriction after chronic dosing with salmeterol. Respiratory Medicine 1994;88(5):363‐8. - PubMed
Roberts 1999 {published data only}
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Rosenthal 1999 {published data only}
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SAS30003 {unpublished data only}
    1. SAS30003. A stratified, randomized, double‐blind, placebo‐controlled, parallel‐group, 12‐week trial evaluating the safety and efficacy of the salmeterol/fluticasone propionate combination in HFA 134a MDI, 42/88mcg BID, and salmeterol in propellant 11/12 MDI, 42mcg BID, fluticasone propionate in propellant 11/12 MDI, 88mcg BID, and placebo propellant HFA 134a MDI in adult and adolescent subjects with asthma. www.ctr.gsk.co.uk.
SAS30004 {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. Journal of Allergy & Clinical Immunology 2001;107(2):S246.
    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. American Journal for Respiratory and Critical Care Medicine 2001;163(5):A863.
    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 beta‐agonists (BA) or inhaled corticosteroids (ICS). Amercian Journal of Respiratory and Critical Care Medicine 2001;163(5):A865.
    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 Clinicial Immunology 2001;107(2):100s.
    1. SAS30004. A randomized, double‐blind, placebo‐controlled, parallel‐group 12‐week trial evaluating the safety and efficacy of the salmeterol/fluticasone propionate combination in GR106642X MDI, 50/250mcg BID, and salmeterol in propellant 11/12 MDI, 50mcg BID, fluticasone propionate in propellant 11/12 MDI, 250mcg BID, and placebo propellant GR106642X MDI in adult and adolescent subjects with asthma. www.ctr.gsk.co.uk 2004.
Schreurs 1996 {published data only}
    1. Schreurs A, Sinninghe Damste H, Graaff C, Greefhorst A. A dose‐response study with formoterol Turbuhaler as maintenance therapy in asthmatic patients. European Respiratory Journal 1996;9(8):1678‐83. - PubMed
Shapiro 2000b {published data only}
    1. Aggarwal SK, Frith LJ, Ho M, Weeks T, Ho SY. Fluticasone propionate/salmeterol delivered from a single inhaler demonstrates synergistic benefits in asthma. Amercian Journal of Respiratory and Critical Care Medicine 2003;167(7):A890.
    1. Bateman ED, Frith L, Braunstein GL. Achieving guideline‐based asthma control ‐ does the patient benefit?. European Respiratory Journal 2002;20(3):588‐95. - PubMed
    1. Bateman ED, Frith L, Ho M. Guideline‐based asthma control reduces maximally the impact of upon patient‐assessed quality of life. Amercian Journal of Respiratory and Critical Care Medicine 2002;165(8):A44.
    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. Dorinsky P, Yancey S, Kral K, Emmett A, House K, Prillaman B, et al. Asthma control with salmeterol/fluticasone propionate (50/250mcg) dry powder combination Diskus has a faster onset of effect compared with salmeterol or fluticasone propionate in patients with asthma. Journal Allergy & Clinical Immunology 2000;161(Suppl 1):A195.
Simons 1997a {published data only}
    1. Malozowski S, Stadel BV, Pian LP. Comparison of beclomethasone, salmeterol, and placebo in children with asthma. New England Journal of Medicine 1998; Vol. 339, issue 10:704‐5. - PubMed
    1. Simons FER. A comparison of Beclomethasone, salmeterol and placebo in children with asthma. New England Journal of Medicine 1997;337(23):1659‐65. - PubMed
    1. Simons FER, et al. A one year placebo controlled study of the efficacy and safety of beclomethasone DP versus salmeterol in glucocorticoid naive children with asthma. Journal of Allergy & Clinical Immunology 1997;99:S402.
SLGA2004 {unpublished data only}
    1. SLGA2004. A randomized, double‐blind, double‐dummy, placebo‐controlled, comparative clinical trial of salmeterol xinafoate via multi‐dose powder inhaler versus salmeterol xinafoate via Diskhaler for four weeks in adolescent and adult subjects with mild‐to‐moderate asthma.. http://ctr.gsk.co.uk 2006.
SLGA3014 1994 {unpublished data only}
    1. SLGA3014. www.fda.gov 2001.
SLGL82 {published data only}
    1. SLGL82. A double‐blind parallel group study of inhaled salmeterol in asthmatic patients. www.ctr.gsk.co.uk 2006.
SLMP03 {unpublished data only}
    1. SLMP03. A single centre, randomised, double‐blind, parallel group, placebo controlled study, to evaluate the effect of inhaled salmeterol xinafoate (50micrograms bd from a Diskhaler) on variations in bronchoconstriction induced by methacholine, in paediatric patients with mild to moderate asthma. www.ctr.gsk.co.uk 2006.
SMART {published data only}
    1. Knobil K, Yancey S, Kral K, Rickard K. Salmeterol Multicentre Asthma Research Trial (SMART): Results from an interim analysis. Chest 2003;124:335s.
    1. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, the SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol. Chest 2006;129(1):15‐26. - PubMed
    1. SLGA5011 SMART. SMART: a double‐blind, randomized, placebo‐controlled surveillance study of asthma event outcomes in subjects receiving either usual pharmacotherapy of asthma or usual pharmacotherapy plus salmeterol 42mcg twice daily. http://www.ctr.gsk.co.uk 2006.
SMS40221 {unpublished data only}
    1. SMS40221. Comparing the efficacy and safety of inhaled salmeterol 50mcg BID and placebo via diskus in patients with reversible airways obstruction. www.ctr.gsk.co.uk 2005.
Starke 1996 {published data only}
    1. Starke I, Luce P. The efficacy and safety of inhaled salmeterol 50 microg bd in older patients with reversible airflow obstruction. Age & Ageing 1996;25(1):67‐71. - PubMed
Steffensen 1995 {published data only}
    1. Steffensen I, Faurschou P. Formoterol as inhalation powder in the treatment of patients with reversible obstructive lung diseases. A 3‐month placebo‐controlled comparison of the effects of formoterol and salbutamol, followed by a 12‐month period with formoterol alone. Ugeskrift for Laeger 1996;158(49):7092‐6. - PubMed
    1. Steffensen I, Faurschou P, Riska H, Rostrup J, Wegener T. Inhaled formoterol dry powder in the treatment of patients with reversible obstructive airway disease. A 3‐month, placebo‐controlled comparison of the efficacy and safety of formoterol and salbutamol, followed by a 12‐month trial with formoterol. Allergy 1995;50(8):657‐63. - PubMed
Stelmach 2002 {published data only}
    1. Stelmach I, Gorski P, Jerzynska J, Stelmach W, Majak P, Kuna P. A randomized, double‐blind trial of the effect of treatment with formoterol on clinical and inflammatory parameters of asthma in children. Annals of Allergy, Asthma, & Immunology 2002;89(1):67‐73. - PubMed
Sussman 1995 {published data only}
    1. Sussman HS. Continuous eformoterol and beta 2‐receptor responsiveness. British Journal of Clinical Practice 1995;81 Suppl:16‐7. - PubMed
Taylor 1998 {published data only}
    1. Taylor DR, Drazen JM, Herbison GP, Yandava CN, Hancox RJ, Town GI. Asthma exacerbations during long term beta agonist use: influence of beta(2) adrenoceptor polymorphism. Thorax 2000;55(9):762‐7. - PMC - PubMed
    1. Taylor DR, Town GI, Herbison GP, Boothman‐Burrell D, et al. Asthma control during long‐term treatment with regular inhaled salbutamol and salmeterol. Thorax 1998;53(9):744‐52. - PMC - PubMed
von Berg 1998 {published data only}
    1. Berg A, Blic J, Rosa M, et al. A comparison of regular salmeterol vs 'as required' salbutamol therapy in asthmatic children. Respiratory Medicine 1998;92(2):292‐9. - PubMed
    1. Berg A, Blic J, Rosa M, et al. Regular salbutamol xinafoate compared with salbutamol as required in children with moderate asthma. American Journal of Respiratory & Critical Care Medicine 1996;4:A76.
von Berg 2003 {published data only}
    1. Berg A, Papageorgiou Saxoni F, Wille S, Carrillo T, Kattamis C, Helms PJ. Efficacy and tolerability of formoterol Turbuhaler in children. International Journal of Clinical Practice 2003;57(10):852‐6. - PubMed
Wallin 1999 {published data only}
    1. Wallin A, Sandstrom T, Soderberg M, Howarth P, Lundback B, Della‐Cioppa G, et al. The effects of regular inhaled formoterol, budesonide, and placebo on mucosal inflammation and clinical indices in mild asthma. American Journal of Respiratory & Critical Care Medicine 1999;159(1):79‐86. - PubMed
Weinstein 1998 {published data only}
    1. Pearlman DS, Bronsky E, Chervinsky P, et al. Inhaled salmeterol powder compared with placebo administered over 12 weeks to children with mild to moderate asthma. American Journal of Respiratory & Critical Care Medicine 1996;153(4):A76.
    1. SLD390. www.fda.gov 2001.
    1. Weinstein S, Pearlman D, Bronsky E, Byrne A, Arledge T, Liddle R, et al. Efficacy of salmeterol xinafoate powder in children with chronic persistent asthma. Annals of Allergy, Asthma, & Immunology 1998;81(1):51‐8. - PubMed
Wolfe 2000a {published and unpublished data}
    1. SLGA3010. A randomized, double‐blind, double‐dummy, comparative clinical trial of salmeterol 50mcg via the Diskus and salmeterol 50mcg via the metered‐dose inhaler versus placebo for 12 weeks in adolescent and adult subjects with mild‐to‐moderate asthma. www.ctr.gsk.co.uk.
    1. Wolfe J, Kreitzer S, Chervinsky P, Lawrence M, Wang Y, Reilly D, et al. Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. Annals of Allergy 2000;84(3):334‐40. - PubMed
Wolfe 2000b {published and unpublished data}
    1. SLGA3011. A randomized, double‐blind, double‐dummy, comparative clinical trial of salmeterol 50mcg via the Diskus and salmeterol 50mcg via the metered‐dose inhaler versus placebo for twelve weeks in adolescent and adult subjects with mild‐to‐moderate asthma.. www.ctr.gsk.co.uk.
    1. Wolfe J, Kreitzer S, Chervinsky P, Lawrence M, Wang Y, Reilly D, et al. Comparison of powder and aerosol formulations of salmeterol in the treatment of asthma. Annals of Allergy 2000;84(3):334‐40. - PubMed
Wolfe 2006 {published data only}
    1. FOR258D2307. www.fda.gov 2004.
    1. Lapidus RJ, Wolfe J, Greos LS, Friedman, Orevillo C, Ziehmer B, et al. Formoterol 24 mcg provides effective bronchodilation and is well tolerated in patients with persistent stable asthma [Abstract]. Journal of Allergy & Clinical Immunology 2005;115(2 Suppl):S150.
    1. Wolfe J, Laforce C, Friedman B, Sokol W, Till D, Della Cioppa G, et al. Formoterol, 24 microg bid, and serious asthma exacerbations: similar rates compared with formoterol, 12 microg bid, with and without extra doses taken on demand, and placebo. Chest 2006;129(1):27‐38. - PubMed
Wronska 1998 {published data only}
    1. Wronska J, Chazan R, Mazurek J, Droszcz W. Treatment with salmeterol and quality of life in patients with asthma. Pneumonologia i Alergologia Polska 1998;66(3‐4):193‐7. - PubMed
Zarkovic 1998 {published data only}
    1. Gotz MH, Taak NK. The efficacy and safety of inhaled salmeterol (50mcg bd) compared with salbutamol (200mcg prn) in children with asthma. European Respiratory Journal 1995;8 Suppl 19:517s.
    1. SMS30013. A multicentre, randomised, double‐blind, crossover study to investigate the efficacy and safety of inhaled salmeterol xinafoate (50µg twice daily from the Diskhaler) compared with placebo (from the Diskhaler) with salbutamol (200µg to use ‘as required’ from the Diskhaler) in children with asthma.. www.ctr.gsk.co.uk.
    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.

References to studies excluded from this review

Akpinarli 1999 {published data only}
    1. Akpinarli A, Tuncer A, Saraclar Y, Sekerel B, 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(1):45‐8. - PMC - PubMed
Arvidsson 1989 {published data only}
    1. Arvidsson P, Larsson S, Lofdahl CG, Melander B, Wahlander L, Svedmyr N. Formoterol, a new long acting bronchodilator for inhalation. European Respiratory Journal 1989;2(4):325‐30. - 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. European Respiratory Journal 1991;4(10):1168‐73. - PubMed
Aziz 1998 {published data only}
    1. Aziz I, Hall IP, McFarlane LC, Lipworth BJ. Beta 2‐adrenceptor 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 1998a {published data only}
    1. Aziz I, Tan KS, Hall IP, Devlin MM, Lipworth BJ. Subsensitivity to bronchoprotection against adenosine monophosphate challenge following regular once‐daily formoterol. European Respiratory Journal 1998;12(3):580‐4. - PubMed
Aziz 1999 {published data only}
    1. Aziz I, Lipworth BJ. A bolus of inhaled budesonide rapidly reverses airway sub‐sensitivity and beta2‐adrenoceptor down‐regulation after regular inhaled formoterol. Chest 1999;115(3):623‐8. - PubMed
Baki 1998 {published data only}
    1. Baki A, Karaguzel G. Short‐term effects of budesonide, nedocromil sodium and salmeterol on bronchial hyperresponsiveness in childhood asthma. Acta Paediatrica Japan 1998;40(3):247‐51. - PubMed
Baumgarten 2002 {published data only}
    1. Baumgarten C, Geldszus R, Behre U, Peslis N, Trautmann M. Initial treatment of symptomatic mild to moderate bronchial asthma with the salmeterol/fluticasone propionate (50/250 microg) combination product (SAS 40023). European Journal of Medical Research 2002;7(1):1‐7. - PubMed
Beach 1993 {published data only}
    1. Beach JR, Young CL, Harkawat R, Gardiner PV, Avery AJ, Coward GA, et al. Effect on airway responsiveness of six weeks treatment with salmeterol. Pulmonary Pharmacology 1993;6(2):155‐7. - PubMed
Becker 1989 {published data only}
    1. Becker AB, Simons F. Formoterol, a new long‐acting selective beta 2‐adrenergic receptor agonist: double‐blind comparison with salbutamol and placebo in children with asthma. Journal of Allergy & Clinical Immunology 1989;84(6):891‐5. - PubMed
Becker 1993 {published data only}
    1. Becker AB, Simons FER. Formoterol, a new beta2 agonist, improves chronic airway hyperresponsiveness in children with asthma. Immunology and Allergy practice 1993;14(7):18‐9.
Bhagat 1995 {published data only}
    1. Bhagat R, Kalra S, Swystun VA, Cockcroft DW. Rapid onset of tolerance to the bronchoprotective effect of salmeterol. Chest 1995;108(5):1235‐9. - PubMed
Bishop 1994 {published data only}
    1. Bishop AL, Chervinsky P, Liddle R, et al. Salmeterol for treatment of reversible obstructive airways disease in children. Journal of Allergy & Clinical Immunology 1994;93:248.
Blake 1992 {published data only}
    1. Blake K, Pearlman D, Scott C, Wang Y, Stahl E, Arledge T. Prevention of exercise‐induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol. Annals of Allergy, Asthma, & Immunology 1999;82(2):205‐11. - PubMed
Boner 1992 {published data only}
    1. Boner A. Salmeterol: long term studies in children. European Respiratory Journal 1992;5:318s.
Booth 1996 {published data only}
    1. Booth H, Bish R, Walters J, Whitehead F, Walters EH. Salmeterol tachyphylaxis in steroid treated asthmatic subjects. Thorax 1996;51(11):1100‐4. - PMC - PubMed
Boulet 1998a {published data only}
    1. Boulet L, Cartier A, Milot J, Cote J, Malo JL, Laviolette M. Tolerance to the protective effects of salmeterol on methacholine‐induced bronchoconstriction‐ influence of inhaled corticosteroids. European Respiratory Journal 1998;11(5):1091‐7. - PubMed
Boulet 2001 {published data only}
    1. Boulet LP, Chakir J, Milot J, Boutet M, Laviolette M. Effect of salmeterol on allergen‐induced airway inflammation in mild allergic asthma. Clinical & Experimental Allergy 2001;31(3):430‐7. - PubMed
Boulet Laviol 1997 {published data only}
    1. Boulet LP, Laviolette M, Boucher S, et al. A twelve‐ week comparison of salmeterol and salbutamol in the treatment of mild‐to‐moderate asthma: a Canadian multicentre study. Journal of Allergy & Clinical Immunology 1997;99(1 Pt 1):13‐21. - PubMed
Bowers 1997 {published data only}
    1. Bowers BW, Cox FM, Kalberg C, et al. The impact of salmeterol on asthma specific quality of life in patients reporting nocturnal asthma awakenings due to asthma. Annals of Allergy, Asthma, & Immunology 1997;78:110.
Boyd 1995 {published data only}
    1. Boyd G. Salmeterol xinafoate in asthmatic patients under consideration for maintenance oral corticosteroid therapy‐ UK Study Group. European Respiratory Journal 1995;8(9):1494‐8. - PubMed
Brambilla 1994 {published data only}
    1. Brambilla C, Chastang C, Georges D, et al. Salmeterol compared with slow release terbutaline in nocturnal asthma: a multi center randomised double blind double dummy sequential clinical trial. Allergy 1994;49(6):421‐6. - PubMed
Brambilla 2003 {published data only}
    1. Brambilla C, Gros V, Bourdeix I. Formoterol 12 microg 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
Britton 1992 {published data only}
    1. Britton MC, Earnshaw JS, Palmer JBD. A twelve month comparison of salmeterol with salbutamol in asthmatic patients. European Respiratory Journal 1992;5(9):1062‐7. - PubMed
Byrnes 1996 {published data only}
    1. Byrnes CA, Weber EA, Moorat A, et al. A Comparison of salmeterol 50mcg bd and 100mcg bd with salbutamol 200mcg qds in paediatric asthma. American Journal of Respiratory & Critical Care Medicine 1996;153(4):A408.
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
Campbell 1999 {published data only}
    1. Campbell LM, Anderson TJ, Parashchak MR, Burke CM, Watson SA, Turbitt ML. A comparison of the efficacy of long‐acting beta 2‐agonists: eformoterol via Turbohaler and salmeterol via pressurized metered dose inhaler or Accuhaler, in mild to moderate asthmatics. Respiratory Medicine 1999;93(7):236‐44. - PubMed
Campbell 2000 {published data only}
    1. Campbell LM, Berggren F, Emmas C. The cost effectiveness of eformoterol via Turbohaler(TM) and salmeterol via pressurised metered dose inhaler and metered dose powder inhaler in mild to moderate asthma. Journal of Medical Economics 2000;3:49‐60.
Carlsen 1995 {published data only}
    1. Carlsen K, Roksund O, Olsholt K, Nja F, Leegaard J, Bratten G. Overnight protection by inhaled salmeterol on exercise‐induced asthma in children. European Respiratory Journal 1995;8(11):1852‐5. - PubMed
Castle 1993 {published data only}
    1. Castle W, Fuller R, Hall J. Serevent nationwide surveillance study:comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. British Medical Journal 1993;306(6884):1034‐7. - PMC - PubMed
Charpin 1992 {published data only}
    1. Charpin D, Vervloet D. Quality of life in moderate chronic asthma: salmeterol versus current treatments. Allergy 1992;47(12 Suppl):230.
Chuchalin 2002 {published data only}
    1. Chuchalin A, Svensson K, Stahl E, Ovcharenko SI, Goriachkina LA, Sidorenko IV, et al. A health‐related quality‐of‐life comparison of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone and noncorticosteroid treatment in asthma: a randomized clinical study in Russia. Respiration 2002;69(5):427‐33. - PubMed
    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
Clark 1993 {published data only}
    1. Clark CE, Ferguson AD, Siddorn J. Respiratory arrests in young asthmatics on salmeterol. Respiratory Medicine 1993;87(3):227‐8. - PubMed
Clauzel 1998 {published data only}
    1. Clauzel AM, Molimard M, Gros V, Lepere E, Febvre N, Michel FB. Use of formoterol dry powder administered for three months via a single dose inhaler in 1,380 asthmatic patients. Journal of Investigational Allergology & Clinical Immunology 1998;8(5):265‐70. - PubMed
Cockcroft 1997 {published data only}
    1. Cockcroft DW, Swystun VA, Bhagat R. Salmeterol and airway response to allergen. Canadian Respiratory Journal 1997;4:37‐40.
Cox 1996 {published data only}
    1. Cox F, Goodwin B, Wenzel S, Rickard K, Kalberg C, Emmett A. Asthma specific quality of life in patients treated with salmeterol or albuterol. Journal of Allergy & Clinical Immunology 1996;97:256.
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(3):714‐9. - PubMed
D5125C00344 {unpublished data only}
    1. D5125C00344. A 3‐month, multi‐centre, double‐blind, double‐dummy, randomised, parallel group, phase III study to investigate the efficacy and safety of formoterol HFA pMDI compared with placebo and Oxis Turbuhaler in subjects with asthma. www.astrazeneca.com 2005.
De Carli 1995 {published data only}
    1. Carli G, Arpinelli F, Irvine SH, Bamfi F, Ravinetto R, Recchia G. Change of quality of life induced by salmeterol and salbutamol in adult asthmatic patients. Therapie 1995;50 Suppl:N118.
De Oliveira 1998 {published data only}
    1. Oliveira M, Jardim J, Faresin S, Lucas S, Nery L. Efficacy of and tolerance to salmeterol compared to salbutamol in patients with bronchial asthma. Revista da Associacao Medica Brasileira 1998;44(3):169‐75. - PubMed
Derom 1992 {published data only}
    1. Derom EY, Pauwels RA, Straten MEF. The effect of inhaled salmeterol on methacholine responsiveness in subjects with asthma up to 12 hours. Journal of Allergy & Clinical Immunology 1992;89(4):811‐5. - PubMed
Di Lorenzo 1995 {published data only}
    1. Di‐Lorenzo G, Morici G, Norrito F, Mansueto P, Melluso M, Purello‐D'Ambrosio F, et al. Comparison of the effects of salmeterol and salbutamol on clinical activity and eosinophil cationic protein serum levels during the pollen season in atopic asthmatics. Clinical & Experimental Allergy 1995;25(10):951‐6. - PubMed
Droszcz 1999 {published data only}
    1. Droszcz P, Droszcz W. Results of 30 days and 12 months treatment with salmeterol in patients with asthma and COPD. Polski Merkuriusz Lekarski 1999;6:266‐7. - PubMed
Faurschou 1992 {published data only}
    1. Faurschou P. Salmeterol and Salbutamol: long term efficacy and safety. European Respiratory Journal 1992;5:317‐8.
Faurschou 1994a {published data only}
    1. Faurschou P, Engel AM, Haanaes OC. Salmeterol in two different doses in the treatment of nocturnal bronchial asthma poorly controlled by other therapies. Allergy 1994;10(827‐32). - PubMed
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
Faurschou 1997 {published data only}
    1. Faurschou P, Dahl R, Jeffery P, et al. Comparison of the anti‐inflammatory effects of fluticasone and salmeterol in asthma‐ A placebo controlled, DB CO with bronchoscopy, bronchial methacholine provocation and lavage [abstract]. European Respiratory Journal 1997;10:243s.
FitzGerald 1999 {published data only}
    1. FitzGerald J, Chapman K, Della Cioppa G, Stubbing D, Fairbarn M, Till M, et al. Sustained bronchoprotection, bronchodilatation, and symptom control during regular formoterol use in asthma of moderate or greater severity. Journal of Allergy & Clinical Immunology 1999;103(31):427‐35. - PubMed
Fitzpatrick 1990 {published data only}
    1. Fitzpatrick MF, MacKay T, Driver H, Douglas H. Salmeterol in nocturnal asthma‐a double blind , placebo controlled trial of a long acting inhaled beta agonist. British Medical Journal 1990;301(6765):1365‐8. - PMC - PubMed
Fuglsang 1998 {published data only}
    1. Fuglsang G, Vikre‐Jorgensen J, Agertoft L, Pedersen S. Effect of salmeterol treatment on nitric oxide level in exhaled air and dose‐response to terbutaline in children with mild asthma. Pediatric Pulmonology 1998;25(5):314‐21. - PubMed
Fuller 1993 {published data only}
    1. Fuller R, Castle W, Palmer J, Hull J. Bronchodilator treatment in asthma. British Medical Journal 1993;306(6892):1611.
Gardiner 1994 {published data only}
    1. Gardiner PV, Ward C, Booth H, et al. Effect of eight weeks treatment with salmeterol on bronchoalveolar lavage inflammatory indices in asthmatics. American Journal of Respiratory & Critical Care Medicine 1994;150(4):1006‐11. - PubMed
Giannini 1995 {published data only}
    1. Giannini D, Carletti A, Dente FL, et al. Tolerance to salbutamol in allergen induced bronchoconstriction. American Journal of Respiratory & Critical Care Medicine 1995;151:A39.
Giannini 1999 {published data only}
    1. Giannini D, Bacci E, Dente FL, Franco A, Vagagginin 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
Gong 1996 {published data only}
    1. Gong H, Linn WS, Shamou DA, et al. Effect of inhaled salmeterol on sulphur dioxide induced bronchoconstriction in asthmatic subjects. Chest 1996;110(5):1229‐35. - PubMed
Goodwin 1996 {published data only}
    1. Goodwin R, Cox F, Lumry W, et al. The impact of salmeterol versus albuterol on disease specific quality of life in mild to moderate asthmatics. Journal of Allergy & Clinical Immunology 1996;97(3):256.
Green 1002 {published data only}
    1. Green C, Price J. Prevention of exercise induced asthma by inhaled salmeterol xinafoate. Archives of Disease in Childhood 1992;67(8):1014‐7. - PMC - PubMed
Greening 1994 {published data only}
    1. Greening AP, Ind PW, Northfield M, Shaw G. Added salmeterol versus higher dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid. Lancet 1994;344(8917):219‐24. - PubMed
Grove 1995 {published data only}
    1. Grove A, Lipworth BJ. Bronchodilator sub‐sensitivity to salbutamol after twice daily salmeterol in asthmatic patients. Lancet 1995;346(8969):201‐6. - PubMed
Grove 1996 {published data only}
    1. Grove A, Lipworth BJ. Effects of prior treatment with salmeterol and formoterol on airway and systemic beta 2 responses to formoterol. Thorax 1996;51(6):585‐9. - PMC - PubMed
Hacki 1993 {published data only}
    1. Hacki M, Ritter A, Medici T. Formoterol: three years therapy in asthma. European Respiratory Journal 1993;6 Suppl 17:529s.
Hekking 1990 {published data only}
    1. Hekking P, Maesen F, Greefhorst A, et al. Long term efficacy of formoterol compared with salbutamol. Lung 1990;168 Suppl:76‐82. - PubMed
Hermansson 1995 {published data only}
    1. Hermansson B, Jenkins R. A 4‐week comparison of salmeterol and terbutaline in adult asthma. Allergy 1995;50(7):551‐8. - PubMed
Jartti 1998 {published data only}
    1. Jartti TT, Kaila TJ, Tahvanainen KU, Kuusela TA, Vanto TT, Valimaki IA. Altered cardiovascular autonomic regulation after salmeterol treatment in asthmatic children. Clinical Physiology 1998;18(4):345‐53. - PubMed
Jenkins 1991 {published data only}
    1. Jenkins M, Hilton C, Kock J, Palmer J. Exacerbations of asthma in patients on salmeterol. Lancet 1991;337(8746):913‐4. - PubMed
Kalra 1996 {published data only}
    1. Kalra S, Swystun V, 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
Kavuru 2000b {published data only}
    1. Kavuru M, Melamed J, Gross G, LaForce C, House K, Prillaman B, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma ‐ a randomized, double‐blind, placebo‐controlled trial. Journal of Allergy & Clinical Immunology 2000;105(6):1108‐16. - PubMed
Kemp 1993 {published data only}
    1. Kemp J, Bukstein D, Busse W. Effective salmeterol, salbutamol and placebo in the prevention of exercise induced bronchospasm. Chest 1993;104 Suppl:10s.
Kemp 1994 {published data only}
    1. Kemp JP, Dockhorn RJ, Busse WW, et al. Prolonged effect of inhaled salmeterol against exercise induced bronchoconstriction after chronic dosing with salmeterol. American Journal of Respiratory & Critical Care Medicine 1994;150(6 Pt 1):1612‐5. - PubMed
Kemp 1998b {published data only}
    1. Kemp J, Cook D, Incaudo G, Corren J, Kalberg C, Emmett A, et al. Salmeterol improves quality of life in patients with asthma requiring inhaled corticosteroids‐ Salmeterol Quality of Life Study Group. Journal of Allergy & Clinical Immunology 1998;101(2 Pt 1):188‐95. - PubMed
Kesten 1991 {published data only}
    1. Kesten S, Chapman KR, Broder I, et al. A three month comparison of inhaled formoterol versus four times daily inhaled albuterol in the management of stable asthma. American Review of Respiratory Disease 1991;144(3 Pt 1):622‐5. - PubMed
Kesten 1992 {published data only}
    1. Kesten S, Chapman KR, Broder I, Cartier A, Hyland RH, Knight A, et al. Sustained improvement in asthma with long‐term use of formoterol fumarate. Annals of Allergy 1992;69(5):415‐20. - PubMed
Kozlik‐Feldmann 1996 {published data only}
    1. Kozlik‐Feldmann R, Berg A, Berdel D, Reinhardt D. Long‐term effects of formoterol and salbutamol on bronchial hyperreactivity and beta‐adrenoceptor density on lymphocytes in children with bronchial asthma. European Journal of Medical Research 1996;1(10):465‐70. - PubMed
Lai 1995 {published data only}
    1. Lai C, Chan C, Ho S, Hui A, Lai K. Inhaled salmeterol and albuterol in asthmatic patients receiving high‐dose inhaled corticosteroids. Chest 1995;108(1):36‐40. - PubMed
Langley 1998 {published data only}
    1. Langley SJ, Masterson CM, Batty EP, Woodcock A. Bronchodilator response to salbutamol after chronic dosing with salmeterol or placebo. European Respiratory Journal 1998;11(5):1081‐5. - PubMed
Langton Hewer 1995 {published data only}
    1. Langton Hewer S, Hobbs J, French D, Lenney W. Pilgrim's progress: the effect of salmeterol in older children with chronic severe asthma. Respiratory Medicine 1995;89(6):435‐40. - PubMed
Lenney 1995 {published data only}
    1. Lenney W, Pedersen S, Boner AL, Ebbutt A, Jenkins M. Efficacy and safety of salmeterol in childhood asthma. European Journal of Pediatrics 1995;154(12):983‐90. - PubMed
Li 1999 {published data only}
    1. Li X, Bamford T, Ward C, et al. Influence of salmeterol on eosinophil inflammation in bronchial biopsies from asthmatics on inhaled steroid. European Respiratory Journal 1998;12 Suppl 28:155s.
    1. Li X, Ward C, Thien F, Bish R, Bamford T, Bao X, et al. An antiinflammatory effect of salmeterol, a long‐acting beta2 agonist, assessed in airway biopsies and bronchoalveolar lavage in asthma. American Journal of Respiratory & Critical Care Medicine 1999;160(5 Pt 1):1493‐9. - PubMed
Lipworth 1998 {published data only}
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Malo 1992 {published data only}
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Mann 1996 {published data only}
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Martin 1999 {published data only}
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McIvor 1998 {published data only}
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Midgren 1992 {published data only}
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Molimard 2001 {published data only}
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Nelson 1999a {published data only}
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Newnham 1993 {published data only}
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Nichol 1990 {published data only}
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Nielsen 1999 {published data only}
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Nix 1990 {published data only}
    1. Nix A, Nichol G, Robson A, Barnes P, Chung K. Effect of formoterol, a long‐lasting beta2‐adrenoceptor agonist, against methacholine‐induced bronchoconstriction. British Journal of Clinical Pharmacology 1990;29(3):321‐4. - PMC - PubMed
Norhaya 1999 {published data only}
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Nowak 1992 {published data only}
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O'Byrne 2001 {published data only}
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Palmer 1992 {published data only}
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Pauwels 1997 {published data only}
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Pearlman 1999 {published data only}
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Ramsdale 1991 {published data only}
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Rhee 1997 {published data only}
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Ringbaek 1996 {published data only}
    1. Ringbaek TJ, Soes‐Petersen U, Christensen M, Iversen ET, Rasmussen FV. Salmeterol compared with salbutamol controlled release in patients with moderate bronchial asthma. Ugeskrift for Laeger 1996;158(27):3940‐3. - PubMed
Rosenhall 1990 {published data only}
    1. Rosenhall L, Sandstrom T, Wallin A. Formoterol, a long acting inhaled b2 agonist, twice daily for 1 year in asthmatic patients. American Review of Respiratory Disease 1990;141:A 210.
Russell 1995 {published data only}
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Ruttenvan Molken1995 {published data only}
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Schaaning 1996 {published data only}
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Self 1998 {published data only}
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Shapiro 2000a {published data only}
    1. Shapiro G, Lumry W, Wolfe J, Given J, White M, Woodring A, et al. Combined salmeterol 50 mug and fluticasone propionate 250 in the diskus device for the treatment of asthma. American Journal of Respiratory & Critical Care Medicine 2000;161(2 Pt 1):527‐34. - PubMed
Shepherd 1991 {published data only}
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Sichletidis 1993 {published data only}
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Siergiejko 1998 {published data only}
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Simons 1992 {published data only}
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SLGA2016 {unpublished data only}
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SLGB4011R {unpublished data only}
    1. SLGB4011R. www.ctr.gsk.co.uk 2005.
SMO30003 {unpublished data only}
    1. SMO30003. A single‐centre, randomised, placebo‐controlled, double‐blind, 3‐way crossover proof‐of‐concept study to evaluate the effect of reduced fine particle mass (FPM) from the salmeterol 50mg GR106642X metered dose inhaler compared with salmeterol 50mg P11/12 metered dose inhaler on the peak bronchodilatory effect and bronchoprotection against methacholine‐induced bronchoconstriction. www.ctr.gsk.co.uk 2005.
SMS30035 {published data only}
    1. SMS30035. A double‐blind, three‐way crossover study comparing GR33343G (Salmeterol) 25µg bd, salmeterol 50µg bd and placebo in the treatment of childhood asthma.. www.ctr.gsk.co.uk 2006.
Smyth 1993 {published data only}
    1. Smyth ET, Pavord ID, Wong C, Wisniewiski ASZ, Williams J, Tattersfield AE. Interaction and dose equivalence of salbutamol and salmeterol in patients with asthma. British Medical Journal 1993;306(6877):543‐5. - PMC - PubMed
Sprogoe‐Jakobsen1992 {published data only}
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Staehr 1995 {published data only}
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Steffensen 1996 {published data only}
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Tan 1997 {published data only}
    1. Tan KS, Grove A, McLean A, Gnosspelius Y, Hall IP, Lipworth BJ. Systemic corticosteroid rapidly reverses bronchodilator sub‐sensitivity induced by formoterol in asthmatic patients. American Journal of Respiratory & Critical Care Medicine 1997;156(1):28‐35. - PubMed
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Tattersfield 2001 {published data only}
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Taylor 1992 {published data only}
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Taylor Jensen 1997 {published data only}
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Twentyman 1990 {published data only}
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Ullman 1988 {published data only}
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Van der Molen 1996 {published data only}
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van der Woude 2001 {published data only}
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Venables 1992 {published data only}
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Verberne 1991 {published data only}
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Verberne 1996 {published data only}
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Weinstein 1997 {published data only}
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    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 & Critical Care Medicine 1995;152(4 Pt 1):1170‐4. - PubMed
Yates 1997 {published data only}
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Zellweger 1994 {published data only}
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