Hampel 2000.
Methods | Setting: multicentre study USA and France Length of intervention period: 6 weeks Randomisation: yes, method not stated Allocation concealment: unclear Masking; double blind Design: parallel group Withdrawals: stated Baseline characteristics: comparable Jadad score: 3 | |
Participants | 270 adults Age range 18‐65 years Inclusion criteria: Adults with mild to moderate asthma for at least 12 months No ICS use for previous 3 months ß‐agonist prn only Increase in FEV1 >/= 15% in response to ß‐agonist Non‐smokers Appropriate use of pMDI Exclusion criteria: Cardiac disease; pulmonary disease other than asthma; Hypersensitivity to BDP A history of alcohol or substance abuse medications other than ß‐agonists prn not permitted in the study | |
Interventions | BDP 50 mcg 2xdaily (100mcg/d)
BDP 100 mcg 2xdaily (200 mcg/d)
Placebo Delivery device: pMDI |
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Outcomes | FEV1 Morning PEF Evening PEF FEF25%‐75% Nights without sleep disturbance Asthma symptoms scores Daily beta2‐agonist use All outcomes reported as change compared to baseline | |
Notes | No reply from the author to clarify method of randomisation and the withdrawal numbers due to side effects | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |