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. 2005 Jan 24;2005(1):CD002738. doi: 10.1002/14651858.CD002738.pub2

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
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