SCO100470

Methods	RCT, parallel group design. Trial duration: 24 weeks. Baseline characteristics: comparable. Intention‐to‐treat analysis: stated.
Participants	Setting: 135 centres in Europe and Asia Pacific. Participants randomised: 1050 (two groups: FPS combination: 518; salmeterol: 532). Baseline characteristics: Mean age: 64 years; FEV1: 1.67L; am PEF: 274; SGRQ: 48. Inclusion criteria: M/F 40‐80 years of age; diagnosis of COPD (according to GOLD criteria); ≥ 2 on MRC dyspnoea scale; poor reversibility of < 10% predicted normal (and < 200 mL); FEV1/FVC ratio < 70% predicted; ≥10 pack year smoking history. Exclusion criteria: Not described.
Interventions	salmeterol 50 mcg bid. FPS 500/50 mcg bid. Inhaler device: DPI.
Outcomes	Withdrawals; FEV1; morning PEF; quality of life (SQRG); symptoms (TDI) adverse events.
Notes	Unpublished study downloaded from ctr.gsk.co.uk
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomised; other information not available.
Allocation concealment (selection bias)	Unclear risk	Information not available.
Blinding (performance bias and detection bias) All outcomes	Low risk	Identical inhaler devices.
Incomplete outcome data (attrition bias) Mortality	Unclear risk	14% withdrew on salmeterol and 11% on FPS.
Incomplete outcome data (attrition bias) All other outcomes	Unclear risk	14% withdrew on salmeterol and 11% on FPS.
Selective reporting (reporting bias)	High risk	Does not contribute data to analysis of exacerbations as rate ratio, dichotomous data or hospitalisations.