| Methods |
Design: parallel‐group
Randomisation: yes, method not stated
Blinding: double‐blind
Withdrawals: not stated |
| Participants |
Setting: multicentre study
Number eligible: not stated
Number enrolled: 194 (152 eligible for van Grunsven meta‐analysis)
Number in treatment group: 81
Number in control group: 71
Number of withdrawals (treatment/control): not stated
Number completing trial (treatment/control): not stated
Age range: not stated
Sex: not stated
Ethnicity: not stated
COPD diagnosis: FEV1 30% to 60% predicted
Severity of COPD: not stated
Inclusion criteria: age <= 75 years, "chronic bronchitis", FEV1 30% to 60% predicted, FEV1 reversibility < 10% predicted, PaO2 > 55 mmHg, usual treatment without corticosteroid, no exacerbation in the last 3 months
Exclusion criteria: other pulmonary diseases, corticosteroids past 15 days, IgE > 200 IU/mL, eosinophils > 500 x 10E3/mL
Baseline characteristics of treatment/control groups: not stated |
| Interventions |
BDP 1500 µg/d
MDI
Placebo
24 months |
| Outcomes |
Level of FEV1
Level of PEFR
Duration of corticosteroid course |
| Notes |
Abstract only
Details from van Grunsven meta‐analysis |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
See Van Grunsven 1999 |
| 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) |
Unclear risk |
Information not available |
