SAM40031

Methods	A 1‐year, randomised, double‐blind, parallel‐group comparison of the efficacy of Seretide (fluticasone propionate/salmeterol combination Accuhaler) and Flixotide (fluticasone propionate Accuhaler) when ICS dose is down‐titrated in adults with asthma who have previously received Seretide 500/50 μg twice daily for at least 4 weeks Study conducted over 52 weeks from March 2002 to February 2006, at 3 centres in Australia
Participants	Population: 82 adolescents and adults (18 to 80 years) with asthma  Baseline characteristics: mean age 47 years; FEV₁ unknown % predicted Concomitant ICS used by 100% of participants  Inclusion criteria: between 18 and 80 years of age with clinical diagnosis of asthma according to ATS criteria for at least 6 months before enrolment; currently receiving fluticasone propionate/salmeterol via dry powder inhaler or metered dose inhaler (with or without spacer) at a dose of 500/50 μg twice daily or 250/25 μg 2 inhalations twice daily for a minimum of 4 weeks before enrolment  Exclusion criteria: not reported
Interventions	• Fluticasone propionate and salmeterol 500/50, 250/50, or 100/50 μg twice daily (reduced incrementally) • Fluticasone propionate 500, 250, or 100 μg twice daily (reduced incrementally) Delivery was DPI
Outcomes	Primary efficacy endpoint: average daily fluticasone propionate dose (μg/d) from week 0 to completion/withdrawal, including study medication and exacerbation medication
Notes	SAE data included run‐in
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	60/82 (73%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website