Sin 2008.

Methods	Design: parallel‐group with run‐in period Randomisation: yes, method not stated Blinding: double‐blind Withdrawals: stated
Participants	Setting: multicentre (11 centres) Number eligible: 356 Number enrolled: 289 Number in groups: 45 placebo, 87 FP 500 bd, 92 FP/salmeterol 500 bd Number of withdrawals: 77 Number completing trial: 212 Age range: mean 69.3 +/‐ 9.3yrs Sex: 63% male Ethnicity: not stated COPD diagnosis: GOLD criteria Severity of COPD: FEV1 47.4 +/‐ 15.9% pred, FVC 74.4 +/‐ 16.3% pred Inclusion criteria: not specified Exclusion criteria: not specified Baseline characteristics of treatment/control groups: comparable
Interventions	Run‐in phase of FP 500mg bd for 4 weeks, followed by a medication withdrawal phase wherein ICS, LABAs, and theophylline products were withdrawn for 4 weeks. All other medications, including short‐acting b2‐adrenoceptor agonists, anticholinergics, and tiotropium, were permitted during all phases of the study. Participants were then randomly assigned to one of three arms: placebo, inhaled FP 500 mg bd or inhaled FP/salmeterol combination 500/50 mg bd.
Outcomes	Primary endpoint ‐ C‐reactive protein (CRP) level. Secondary endpoints ‐ IL‐6, surfactant protein D (SP‐D), SGRQ, FEV1 % predicted, FVC % predicted
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method not stated
Allocation concealment (selection bias)	Unclear risk	Method not stated
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Similar withdrawal rates between arms
Selective reporting (reporting bias)	Low risk	All outcomes reported