SAM30007

Methods	A randomised, double‐blind, multi‐centre, parallel‐group study over 30 weeks from September 2000 to May 2002, at 5 centres in Denmark. Run‐in 2 weeks A comparative investigation of the corticosteroid‐saving potential of the combination therapy fluticasone propionate and salmeterol (SERETIDE) vs fluticasone propionate alone, given to adults with asthma, when the ICS dose was reduced from an initially high level of 500 μg twice daily
Participants	Population: 61 adults (18+ years) with stable asthma   Baseline characteristics: mean age 37 years; FEV₁ not reported % predicted Concomitant ICS used by 100% of participants   Inclusion criteria: at least 18 years old with a clinical diagnosis of stable asthma; treated with 1500 to 2000 μg of budesonide, beclomethasone dipropionate, or flunisolide, or 750 to 1000 μg of fluticasone propionate, for at least 10 weeks before the study; FEV₁ % predicted ≥ 60%; had to be able to use the data capture method (electronic diary, AM‐2) correctly  Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 500/50, 250/50, or 100/50 μg twice daily • Fluticasone propionate 500, 250, or 100 μg twice daily
Outcomes	Primary efficacy endpoint: minimum dose at which the participant’s asthma remained controlled ‐ the minimum acceptable dose (MAD)
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	55/61 (90%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website