SAM40008

Methods	A multi‐centre, randomised, double‐blind, parallel‐group comparison of the efficacy of SERETIDE* twice daily and fluticasone propionate twice daily (both via Diskus*/ACCUHALER*, Inhaler) when tapering the inhaled corticosteroid dose in asthmatic adults Carried out over 26 weeks from May 2000 to July 2001, at 34 centres in 10 countries (Australia, Estonia, Finland, France, Germany, Israel, Latvia, New Zealand, Spain, United Kingdom)
Participants	Population: 186 adults (18+ years) with persistent asthma  Baseline characteristics: mean age 50 years; FEV₁ unknown % predicted Concomitant ICS used by 100% of participants  Inclusion criteria: 18 years of age or older with documented evidence of asthma within previous 2 years who were receiving 1500 to 2000 μg/d of BUD or equivalent ICS, excluding fluticasone propionate, for at least 3 months before the start of baseline  Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 500/50 μg twice daily • Fluticasone propionate 500 μg twice daily Delivery as DPI
Outcomes	Primary efficacy endpoint: minimum acceptable daily dose of ICS
Notes	Sponsored by GSK. High dropout rate. Only 8% completed the study
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	High risk	Only 14/186 (8%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website