Matthys 1998.
Methods | Setting: multicentre study Germany, hospital outpatient clinic Length of intervention period: 6 weeks Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel group Masking: double blind, double dummy Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 3 | |
Participants | 256 adult patients: 129M 127F Age range: 18 to 65 years Inclusion criteria: Diagnosis of asthma for at least 4 weeks Moderate severity disease according to GINA criteria Increase in FEV1 of at least 15% following inhaled beta2 agonist Using inhaled beta2 agonist for relief of symptoms No use of inhaled steroids for at least 3 weeks before trial PEFR 50‐80 (% predicted) over last 7 days of 2 week run‐in period Exclusion criteria: Smoker within last 6 months Cardiac or pulmonary disease other than asthma Known hypersensitivity to BDP Respiratory tract infection within last 4 weeks | |
Interventions | BDP:
1. 50 mcg 4 pfs 2x daily (400 mcg/d)
2. 100 mcg 2pfs 2xdaily (400 mcg/d) Placebo: 2 or 4 pfs 2xdaily Delivery device: HFA propellant MDI |
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Outcomes | Change in morning PEFR compared to baseline Change in FEV1 compared to baseline Daily use of beta2 agonist % nights free from sleep disturbance Withdrawal due to asthma exacerbation (number of patients) Oro‐pharyngeal side effects | |
Notes | Reply from author, request for details of randomisation method forwarded to sponsoring pharmaceutical company but no reply. The investigators pool the results for both groups of patients treated with BDP delivered by different schedules. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |