Godard 2008

Methods	A randomised, double‐blind, 24‐week, multi‐centre study at 124 centres in France; 8‐week open run‐in on SFC (50/250 μg twice daily)
Participants	Population: 308 adults (18+ years) with asthma controlled on ICS (1000 μg CFC beclomethasone equivalent daily) and LABA  Baseline characteristics: mean age 44 years; FEV₁ 90% predicted Concomitant ICS used by 100% of participants   Inclusion criteria: currently receiving ICS at a dose of 1000 μg daily of inhaled BDP or equivalent and LABA. Asthma controlled on a stable dose for at least 4 weeks were entered into run‐in, and then entered into the full study if asthma was well controlled (as defined in GOAL) in last 2 weeks of 8‐week run‐in on fluticasone propionate/salmeterol Exclusion criteria: excluded from entry into the run‐in period if smoking history of ≥ 10 pack‐years, respiratory tract infection during last 4 weeks before initial clinic visit (V1), acute asthma exacerbation requiring emergency room treatment or hospitalisation within 4 weeks before V1, use of oral/parenteral corticosteroids during last 4 weeks before V1 (12 weeks for depot corticosteroids), any change in asthma maintenance treatment in previous 4 weeks
Interventions	• Fluticasone propionate and salmeterol 250/50 μg twice daily • Fluticasone 250 μg twice daily • Fluticasone propionate/salmeterol 100/50 μg twice daily (not analysed in this review) Delivery device Diskus
Outcomes	Primary efficacy endpoint: variation in mean morning PEF over first 12 weeks of the treatment period compared to last 2 weeks of the run‐in period (baseline)
Notes	Sponsored by GSK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	"Double‐blind randomised 24‐week study"
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	Uneven withdrawals (18/159 on fluticasone propionate/salmeterol and 30/159 on fluticasone)
Selective reporting (reporting bias)	Low risk	Full SAE data reported in paper