SAS30022

Methods	A randomised, double‐blind, placebo‐controlled, parallel‐group study for 12 weeks from November 2001 to June 2003, at 121 centres (US (103), Canada (18)) A trial evaluating the efficacy and safety of the fluticasone propionate/salmeterol Diskus combination product 250/50 μg once daily vs fluticasone propionate/salmeterol Diskus combination product 100/50 μg twice daily vs fluticasone propionate Diskus 250 μg once daily vs placebo in symptomatic adolescent and adult patients with asthma that is not controlled on short‐acting beta₂‐agonists alone
Participants	Population: 844 adolescents and adults (12+ years) with asthma that was not controlled on SABA alone  Baseline characteristics: mean age 33 years; FEV₁ not reported % predicted Concomitant ICS used by 0% of participants Inclusion criteria: 12 years of age or older with diagnosis of asthma for at least 3 months and treated with short‐acting beta₂‐agonists only for at least 1 month before screening; FEV₁ % predicted between 50% and 85%; bronchodilator reversibility by an increase of at least 15% in FEV₁ over baseline within 30 minutes following 2 puffs of albuterol at screening. At the randomisation visit, participants were required to demonstrate FEV₁ reproducibility of ±15% of the screening visit pre‐ventolin FEV₁, to demonstrate a PM PEF 50% to 90% of predicted normal, and to have an asthma symptom score ≥ 2 on ≥ 4 days in the week before randomisation or to have used ventolin on ≥ 4 days in the week before randomisation  Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 250/50 μg once daily • Fluticasone propionate and salmeterol 100/50 μg twice daily • Fluticasone propionate 250 μg once daily (second arm not used in this review)
Outcomes	Primary outcome/efficacy variable: change from baseline in % predicted PM PEF over weeks 1 to 12
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	Unclear risk	698/844 (83%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website