| Methods | A randomised, double‐blind, parallel‐group study over 12 weeks. Run‐in 2 to 4 weeks | |
| Participants |
Population: 56 patients, previously not well controlled on
ICS Baseline characteristics: mean age 42 years; FEV₁ 88% predicted Concomitant ICS used by 100% of participants Inclusion criteria: asthma symptoms on ≥ 6 days or ≥ 4 nights; need for rescue salbutamol on ≥ 6 days or ≥ 4 nights; > 20% variation between AM and PM PEF on ≥ 4 days; pulmonary function, ≥ 1 of the following: ≥ 15% increase in FEV₁ 15 minutes after inhalation of 400 to 800 μg salbutamol, ≥ 15% increase in PEF 15 minutes after inhalation of 400 to 800 μg salbutamol compared to mean AM PEF values in the preceding week, > 20% variation between AM and PM PEF on ≥ 4 consecutive days, PC20 methacholine < 4 mg/mL Exclusion criteria: not reported as such |
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| Interventions | • Fluticasone propionate 200 + salmeterol 50 μg twice daily • Fluticasone propionate 200 μg twice daily • Fluticasone propionate 500 μg twice daily (not used in this review) Delivery was Diskus device |
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| Outcomes |
Primary endpoints: submucosal eosinophil and mast cell counts No information in the paper, but no SAEs reported on the GSK website |
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| Notes | Sponsored by GSK | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |
| Independent Assessment of causation (detection bias) Asthma‐related events | High risk | Causation of SAEs not independently assessed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 46/56 (82%) completed the study |
| Selective reporting (reporting bias) | Low risk | SAE data on GSK website |
ACQ: Asthma Control Questionnaire; AE: adverse event; ATS: American Thoracic Society; AUC: area under the curve; BDP: beclomethasone dipropionate; BHR: bronchial hyperresponsiveness; BUD: budesonide; CFC: chlorofluorocarbon; DPI: dry powder inhaler; DRC: daily record card; ECG: electrocardiogram; ECP: eosinophil cationic protein; FEV₁: forced expiratory volume in one second; GSK: GlaxoSmithKline; HFA: hydrofluoroalkane; ICS: inhaled corticosteroid; LABA: long‐acting beta₂‐agonist; LTRA: leukotriene receptor antagonist; MAD: minimum acceptable dose; MDI: metered dose inhaler; NCT: National Clinical Trial; OCS: oral corticosteroid; PC20: concentration needed to produce a 20% fall in FEV₁; PEF: peak expiratory flow; SABA: short‐acting beta₂‐agonist; SAE: serious adverse event.