Weir 1999.
| Methods | Design: parallel group Randomisation: yes, method not stated Blinding: double blind, double dummy Withdrawals: stated |
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| Participants | Setting: multicentre study, UK, hospital outpatient clinic Number eligible: not stated Number enrolled: 98 Number in treatment group: 49 Number in control group: 49 Number of withdrawals (treatment/control): 39 total Number completing trial (treatment/control): 59 total Age range: adult (mean 65.5 yr in intervention group, 67.6 yr in control group Sex: 73M, 15F Ethnicity: not stated COPD diagnosis: clinical diagnosis of COPD, adult onset airflow obstruction , FEV1 <70% predicted, FEV1/FVC <65% Severity of COPD: Mean pre‐bronchodilator FEV1 39.7% in intervention group, 41.4% in control group Inclusion criteria: as for COPD diagnosis Exclusion criteria: clinical diagnosis of asthma (including clinical significant bronchodilator reversibility, acute attacks of breathlessness with recovery between attacks), significant improvement with steroid treatment in the past, steroid treatment clinically indicated, use of steroids >3 month in last 1 yr or during last 4 wk Baseline characteristics of treatment/control groups: more females in the intervention group |
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| Interventions | BDP 750 µg, 2 times a day (1500 µg/d) for weight <50 kg, BDP 1000 µg, 2 times a day (2000 µg/d) for weight >50 kg Placebo 2 times a day Metered dose inhaler (identical) via spacer device 2 years |
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| Outcomes | Change in pre‐bronchodilator FEV1 Change in pre‐bronchodilator FVC Change in post‐bronchodilator FEV1 Change in post‐bronchodilator FVC PC20 histamine Exacerbations Dyspnoea index CRQ (subgroup) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised". Method not stated |
| 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 | Information not available |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |