Ozol 2005.

Methods	Design: parallel‐group Randomisation: yes, computer‐generated Blinding: double‐blind Withdrawals: stated
Participants	Setting: single‐centre study, Turkey Number eligible: not stated Number enrolled: 26 Number in treatment group: 13 Number in control group: 13 Number of withdrawals (treatment/control): 1/3 Number completing trial (treatment/control): 12/10 Age range: mean 65 years Sex: 18 M, 4 F Ethnicity: not stated COPD diagnosis: stable mild to moderate COPD (GOLD criteria) (mild = > 80% predicted FEV1; moderate = 50% to 80% predicted FEV1) Severity of COPD: FEV1 61.1% predicted (BUD); FEV1 57.3% predicted (placebo) Inclusion criteria: FEV1/FVC < 70%, FEV1 > 50% predicted; reversibility of < 200 mL with inhaled salbutamol or less than 12% predicted FEV1; stable COPD; no other systemic or pulmonary disease; no therapy with inhaled or systemic corticosteroids within 3 months; no history asthma or atopy Exclusion criteria: not stated Baseline characteristics of treatment/control groups: comparable
Interventions	BUD 400 µg, 2 times a day (800 µg/day) Placebo
Outcomes	Spirometry BAL cell counts and via bronchoscopy IL8 count Weekly diary ‐ change in cough, dyspnoea, sputum production noted
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomised by computer‐generated, blinded randomisation list"
Allocation concealment (selection bias)	Low risk	Quote: "treatment randomly assigned"
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "double‐blinded"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Withdrawals: 1 BUD, 2 placebo
Selective reporting (reporting bias)	Low risk	All outcomes reported