SCO30002.

Methods	Design: Multicentre, Randomised, Double‐Blind, Parallel Group, Placebo‐Controlled Study Duration: 12 months (+ 2 week run‐in) Location: 49 centres in Italy and 7 in Poland
Participants	Population: 387 participants were randomised to fluticasone (131), fluticasone/salmeterol combination (131), and placebo (125) Baseline characteristics Age (mean years): flut 64.6, flut/salm 63.9, pbo 65.7 % Male: flut 83.2, flut/salm 84.0, pbo 80.0 % FEV1 predicted: not reported Pack‐years (mean): not reported Inclusion criteria: Male or female subjects aged > 40 years with an established clinical history of COPD; subjects who demonstrated at Visit 1 a pre‐bronchodilator baseline FEV1/VC <88% for men and <89% for women of predicted normal values and FEV1 ≤70% of predicted normal value, but >800mL; subjects who demonstrated at Visit 1, poor reversibility of airflow obstruction, defined as an increase of FEV1 <10% of the normal predicted FEV1 value (or <200 ml from baseline), 30 minutes after inhalation of 400 μg salbutamol via MDI;. current or ex‐smokers with a smoking history of at least 10 pack‐years Exclusion criteria: As above
Interventions	1. Fluticasone 500 bid (ICS) 2. Salmeterol/fluticasone 50/500 bid (LABA/ICS) 3. Placebo (PBO) Inhaler device: metered dose Allowed co‐medications: not reported
Outcomes	COPD exacerbations, clinic FEV1, VC, FEV1/VC, daily record card symptoms, PEFR, distance walked in the six minute walk test (SWT), perceived breathlessness before and after SWT, quality of life (SGRQ), use of relief medication, adverse events, SAEs on therapy
Notes	Funding: GlaxoSmithKline Identifier(s): GSK SCO30002
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised to treatment. No details given but assumed to adhere to GSK methodology
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Described as double‐blind [presumed participants and personnel/investigators]
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropout high at 26% and 32% for ICS and placebo respectively but even. The Safety population/Intent‐to‐treat (ITT) population consisted of all randomised patients who took study medication (all of those randomised).
Selective reporting (reporting bias)	Low risk	All outcomes stated in the GSK summary were reported in detail