SAS40037

Methods	A randomised, double‐blind, double‐dummy, multi‐centre, parallel‐group study for 16 weeks from October 2001 to May 2003, at 87 centres in the United States. Run‐in 2 weeks
Participants	Population: 331 adolescents and adults (15+ years) with persistent asthma Baseline characteristics: mean age 41 years; FEV₁ not reported (% predicted) Concomitant ICS used by 100% of participants   Inclusion criteria: 15 years of age or older with diagnosis of asthma, as defined by the ATS, for at least 6 months before visit 1; must have been treated with an allowed ICS at a fixed dosing regimen (within an allowed total daily dose) for at least 4 weeks before the screening visit; FEV₁ % predicted between 40% and 85%; bronchodilator reversibility by an increase of ≥ 12% in FEV₁ over baseline within 30 minutes following 2 to 4 puffs of albuterol inhalation aerosol at the screening visit. Documentation of historical reversibility within 24 months was allowed  Exclusion criteria: diagnosis of life‐threatening asthma, hospitalised for asthma within previous 6 months, concurrent respiratory disease or intermittent or seasonal asthma alone, respiratory tract infection or used antibiotics for treatment of a suspected or diagnosed respiratory tract infection within 14 days of visit 1
Interventions	• Fluticasone propionate and salmeterol 100/50 μg twice daily • Fluticasone propionate 100 μg twice daily Delivery was Diskus device (other arms of trial not considered for this review)
Outcomes	Primary efficacy endpoint: mean change from baseline at endpoint in morning PEF
Notes	Sponsored by GSK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind, double‐dummy
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	230/322 (71%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website