Verhoeven 2002.

Methods	Design: Randomised, double‐blind, placebo‐controlled study Duration: 6 months (+ 2 week run‐in) Location: single centre in the Netherlands
Participants	Population: 23 participants were randomised to fluticasone (10) and placebo (13) Baseline characteristics Age (mean years): flut 54, pbo 56 % Male: flut 80, pbo 84.6 % FEV1 predicted: flut 66, pbo 61 Pack‐years (mean): flut 25, pbo 26 Inclusion criteria: Chronic productive cough, FEV1 <70% of predicted normal value, FEV1 reversibility of <10% predicted after 750 mg terbutaline administered by metered dose inhalation, negative serological examination (Phadiatop test), and negative skin prick tests for standard inhaled allergens).22 Patients with an FEV1/inspiratory vital capacity (IVC) ratio of <0.70 were also included, provided their total lung capacity (TLC) was greater than the predicted value + 1.64SD. Reference values were obtained from ECGS standards.23 Participants had to be current and persistent smokers aged 40–70 years. Exclusion criteria: History of asthma characterised by attacks of dyspnoea, chest tightness or wheezing, respiratory tract infection in the 4 weeks preceding the first visit, or were suffering from serious or unstable concomitant disease
Interventions	1. Fluticasone 500 BID (ICS) 2. Placebo (PBO) Inhaler device: Diskhaler Allowed co‐medications: Eligible patients using anti‐inflammatory treatment including non‐steroidal anti‐inflammatory drugs were asked to refrain from oral prescriptions for at least 3 months and from inhaled corticosteroids, sodium cromoglycate, or nedocromil sodium for at least 6 weeks before the start of the study. Long acting b2 agonists, xanthine derivatives, and antihistamine drugs also had to be stopped at least 6 weeks before the start of the study.
Outcomes	Use of secondary medication, compliance, FEV1, PC20, FEV1/FVC, cortisol levels and inflammatory markers
Notes	Funding: GlaxoWellcome Identifier(s): FLIL44/FMS40060
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly allocated [no details, but industry funded]
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	No dropouts in either group
Selective reporting (reporting bias)	Low risk	Adverse event data not adequately reported but information supplied by the author.