Cilomilast 110.

Study characteristics
Methods	Study design: parallel‐group study Randomisation: randomised, double‐blind, placebo‐controlled trial Trial duration: 12 weeks Analysis was done on per‐protocol population
Participants	Setting: 10 centres in the USA Participants: 65 (15 mg cilomilast: 31, placebo: 34) Baseline characteristics: mean age 64.4 years placebo and 66.1 years cilomilast, 67% male placebo and 84% male cilomilast, mean FEV₁ % predicted not available Inclusion criteria: aged 40 to 80 years, FEV₁/FVC ≤ 0.7 with smoking history > 10 pack‐years, post‐salbutamol reversibility ≤ 15% or 200 mL, post‐salbutamol FEV₁ ≥ 1.0 L and between 30% and 70% predicted Exclusion criteria: not stated Total numbers of participant withdrawals: 1 (3%) and 1 (3%) from treatment and control groups, respectively
Interventions	Run‐in: not stated Cilomilast 15 mg twice daily Placebo twice daily Concomitant medication Short‐acting anticholingeric: no information available SABA: no information available Corticosteroid: no information available LABA: no information available
Outcomes	Primary outcome: change from baseline at endpoint in neutrophils as a percentage of total cells in induced sputum Secondary outcomes: FVC at trough; sputum macrophages, eosinophils, and lymphocytes as a percentage of total cells in induced sputum; total cell counts in induced sputum
Notes	Funded by GlaxoSmithKline
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Assumed that trialists used a robust method to carry out the randomisation process because of pharmaceutical sponsorship
Allocation concealment (selection bias)	Low risk	Assumed that trialists used a robust method to carry out the randomisation process because of pharmaceutical sponsorship
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The trial was double‐blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assumed that this would be low risk; however, no available information
Incomplete outcome data (attrition bias) All outcomes	Low risk	Total numbers of participants withdrawn 1 (3%) placebo, 1 (3%) cilomilast
Selective reporting (reporting bias)	Low risk	Outcomes were reported as planned. Trial information was reported on the GSK website only
Other bias	Unclear risk	No information on baseline anticholinergic, beta₂‐agonist, or corticosteroid use