Hattotuwa 2002.

Methods	Design: parallel‐group Randomisation: yes, random number table Blinding: double‐blind Withdrawals: stated
Participants	Setting: hospital outpatient clinic Number eligible: not stated Number enrolled: 37 Number in treatment group: 17 Number in control group: 19 Number of withdrawals (treatment/control): 1/5 + 1 insufficient biopsy Number completing trial (treatment/control): 16/14 Age range: 40 to 75 years Sex: 26 M, 4 F Ethnicity: not stated COPD diagnosis: FEV1 25% to 80% of predicted Severity of COPD: mean FEV1 % predicted FP 46.2%, placebo 45.5% Inclusion criteria: current or ex‐smokers > 20 pack‐years Exclusion criteria: atopy, acute bronchodilator reversibility, severe concurrent medical problems, chest infection within 8 weeks before study Baseline characteristics of treatment/control groups: comparable
Interventions	FP 500 µg, 2 times a day (1,000 µg/d) Placebo Multidose dry powder inhaler (Accuhaler) 3 months
Outcomes	Peak flow Symptom score Spirometry Exhaled carbon monoxide Bronchoscopy Exacerbations
Notes	Run‐in 8 weeks Had steroid trial (prednisolone 30 mg, 2 weeks) after cessation of FP for 1 month
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "random number table"
Allocation concealment (selection bias)	Unclear risk	Information not available
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "double blind"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Withdrawals: 1 FP, 5 placebo
Selective reporting (reporting bias)	Low risk	All outcomes reported