Schermer 2009.

Methods	Design: randomised, double blind, double dummy, placebo‐controlled phase IV trial Duration: 3 years (preceded by an optional smoking cessation stage, 3 month washout period and 14 day pre‐treatment phase) Location: 44 general practices in the Netherlands
Participants	Population: 190 participants were randomised to fluticasone (94) and placebo (96) Baseline characteristics Age (mean years): flut 58.4, pbo 59.6 % Male: flut 73, pbo 68 % FEV1 predicted: flut 63.2, pbo 65.7 Pack‐years (mean): flut 30.2, pbo 26.5 Inclusion criteria: Age 35‐75 years; current or former smoker; chronic dyspnoea, sputum production and cough for at least three consecutive months per year during the previous two years; post‐bronchodilator forced expiratory volume in one second (FEV1) <90% of the predicted value, and/or post‐bronchodilator FEV1/FVC (forced vital capacity) of the predicted value <88% for men and <89% for women. Exclusion criteria: Post‐bronchodilator FEV1 <40% of predicted and/or a history of asthma, allergic rhinitis, or allergic eczema
Interventions	1. Fluticasone 500 bid (ICS) 2. Placebo (PBO) Inhaler device: Diskus dry powder inhaler. Unclear from trial report whether the placebo was administered to match the fluticasone inhaler or the other active treatment which was delivered as effervescent tablets dissolved in a glass of tap Allowed co‐medications: not reported
Outcomes	Rate of exacerbations and quality life as measured with the interviewer‐administered version of the Chronic Respiratory Questionnaire (CRQ)
Notes	Funding: Dutch Council for Health Insurances, with complementary funding by the Netherlands Asthma Foundation (authors had received various GSK and other pharmaceutical research grants) Identifier(s): unknown
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An independent statistician generated a randomisation list based on a block size of three for treatment allocation to balance the three treatment arms by study centre.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Neither investigators nor patients were aware of the group assignment. Placebo described as ‘matching’
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Neither investigators nor patients were aware of the group assignment [presuming the investigators were those doing the outcome assessments]
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropout was high in both groups. The primary analyses were done on an intention‐to‐treat basis. Additional per protocol analyses were done on patients with a trial medication compliance rate >80%. Unclear how data were imputed or who was included in the ITT population
Selective reporting (reporting bias)	High risk	All outcomes stated in the protocol were reported but some key expected outcomes were missing (serious adverse events and pneumonia). No reply from author by time of publication.