Nishimura 1999.

Methods	Design: cross‐over, no washout Randomisation: yes, computer‐generated (correspondence from Dr Koyama, 3 June 2002) Blinding: double‐blind, double‐dummy Withdrawals: stated
Participants	Setting: single‐centre study, Japan, hospital outpatient clinic Number eligible: not stated Number enrolled: 34 Number in treatment group: 34 (cross‐over) Number in control group: 34 (cross‐over) Number of withdrawals (treatment/control): 4 withdrawals Number completing trial (treatment/control): 30 (cross‐over) Age range: > 55 years Sex: 29 M, 1 F (of the 30 who completed the study) Ethnicity: not stated COPD diagnosis: smoking > 20 pack‐years, chest radiographs showing hyperinflation, post‐bronchodilator FEV1/FVC < 0.7, FEV1 < 80% predicted Severity of COPD: mean FEV1 37.4% predicted Inclusion criteria: stable (no acute exacerbation of airflow obstruction within last 3 months) Exclusion criteria: asthma, heart disease, any other significant medical condition, use of inhaled or oral steroids in last 3 weeks Baseline characteristics of treatment/control groups: cross‐over
Interventions	BDP 750 µg, 4 times a day (3000 µg/day) Placebo 4 times a day Metered‐dose inhaler with spacer device 4 weeks each treatment period (cross‐over)
Outcomes	Change from baseline pre‐bronchodilator FEV1 Change from baseline pre‐bronchodilator FVC Change from baseline post‐bronchodilator FEV1 Change from baseline post‐bronchodilator FVC Peak flow (last 14 days of 4‐week period) Symptoms (last 14 days of 4‐week period) Adverse effects Serum osteocalcin Serum cortisol
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomised"
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	Low risk	Withdrawals: 4 (cross‐over)
Selective reporting (reporting bias)	Low risk	All outcomes reported