SFA103153

Methods	A randomised, double‐blind, multi‐centre, parallel‐group study for 52 weeks from November 2004 to April 2007, at 59 centres in the United States. Run‐in 4 weeks
Participants	Population: 475 adolescents and adults (12 to 65 years) of African descent with persistent asthma  Baseline characteristics: mean age 32 years; FEV₁ 78% predicted Concomitant ICS used by 100% of participants   Inclusion criteria: patients were of African descent, 12 to 65 years of age, with persistent asthma, and were symptomatic while taking an ICS Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 100/50 μg twice daily • Fluticasone propionate 100 μg twice daily Delivery was Diskus device
Outcomes	Primary efficacy endpoint: asthma exacerbation rate per patient per year
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
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	320/475 (67%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website