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

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
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
HHS Vulnerability Disclosure