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. 2012 Jul 11;2012(7):CD002991. doi: 10.1002/14651858.CD002991.pub3

Robertson 1986.

Methods Design: cross‐over, 2 weeks washout
 Randomisation: yes, method not stated (correspondence from Professor Burge ‐ 15 October 2002: double‐blind, allocation concealment used)
 Blinding: double‐blind, double‐dummy
 Withdrawals: stated
Participants Setting: single‐centre study, hospital outpatient clinic
 Number eligible: 83
 Number enrolled: 83
 Number in treatment group: 83 (cross‐over)
 Number in control group: 83 (cross‐over)
 Number of withdrawals (treatment/control): not stated
 Number completing trial (treatment/control): not stated
 Age range: mean 61 years (SD 10)
 Sex: 66 M, 17 F
 Ethnicity: no stated
 COPD diagnosis: FEV1 < 70% predicted
 Severity of COPD: mean FEV1 44% predicted
 Inclusion criteria: COPD of at least 5 years duration, chronic bronchitis on MRC questionnaire, 92% were current or ex‐smokers
 Exclusion criteria: asthma, steroid therapy in previous 6 months
 Baseline characteristics of treatment/control groups: comparable (cross‐over)
Interventions BDP 500 µg, 3 times a day (1500 µg/day)
Placebo 3 times a day
Metered‐dose inhaler
2 weeks each treatment period (cross‐over)
Outcomes FEV1 in treatment period compared to baseline or placebo
 FVC in treatment period compared to baseline or placebo
 PEFR in treatment period compared to baseline or placebo
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Correspondence from Professor Burge ‐ double‐blind, allocation concealment used
Comment: probably done
Allocation concealment (selection bias) Low risk Correspondence from Professor Burge ‐ double‐blind, allocation concealment used
Blinding (performance bias and detection bias) 
 All outcomes Low risk Correspondence from Professor Burge ‐ double‐blind, allocation concealment used
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants completed the study
Selective reporting (reporting bias) Low risk Outcomes all reported