Skip to main content
. 1999 Oct 25;1999(4):CD003274. doi: 10.1002/14651858.CD003274

Osterman 1997.

Methods Setting: multicentre study Sweden, hospital outpatient clinic 
 Randomisation: yes, computer‐generated randomisation sequence 
 Allocation concealment: yes (codes held by pharmaceutical company sponsors) 
 Design: parallel 
 Intervention period: 12 months 
 Masking: double blind 
 Excluded: not stated 
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score=5
Participants 75 subjects: 33M 42F 
 Age range: 18‐68 years 
 Inclusion criteria: 
 Clinical diagnosis of asthma, made not more than 1 year previously 
 Histamine BHR (PD20 FEV1) < 0.66 mg 
 Exclusion criteria: 
 Teatment with anti‐inflammatory drugs within previous 3 months
Interventions BUD: 200 mcg 1pf 2xdaily (400 mcg/d)
Placebo: 1pf 2xdaily
Delivery device: Turbuhaler DPI
Outcomes Change in FEV1 and % predicted FEV1 compared to baseline 
 Histamine BHR (PD20 FEV1) 
 Change in daytime and night‐time beta2 agonist use 
 Change in serum ECP, MPO, ECA and NCA compared to baseline 
 Withdrawal due to asthma exacerbation
Notes Reply from pharmaceutical company sponsors confirming use of allocation concealment
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate