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) |
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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 |