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. 1999 Oct 25;1999(4):CD003274. doi: 10.1002/14651858.CD003274

Haahtela 1994.

Methods Setting: Finland, hospital outpatient clinic 
 Randomisation: yes, method not stated 
 Allocation concealment: unclear 
 Design: parallel 
 Intervention period: 12 months 
 Masking: double blind 
 Excluded: not stated 
 Withdrawals: stated (none) 
 Baseline characteristics: comparable 
 Jadad score=3
Participants 37 adults: 11M 26F 
 Mean (SD) age: budesonide group 35.9 (2.4) years, placebo 41.0 (2.8) years 
 Inclusion criteria: 
 Adults with asthma 
 15% or greater increase in FEV1 after inhaled beta2 agonist or 15% or greater decrease in FEV1 following exercise test 
 FEV1 (% predicted) > 80 
 Histamine BHR (PC15 FEV1): < 32 mg/ml 
 Exclusion criteria: 
 Regular corticosteroid or cromolyn treatment 
 Smokers
Interventions BUD: 200 mcg 1 pf 2xdaily (400 mcg/d)
Placebo: 1 pf 2xdaily
Delivery device: Turbuhaler DPI
Outcomes Change in FEV1 compared to baseline 
 Change in FVC compared to baseline 
 Change in morning PEFR a compared to baseline 
 Change in evening PEFR compared to baseline 
 Histamine BHR (PC15 FEV1): change in doubling doses compared to baseline 
 Change in daily beta2 agonist use compared to baseline 
 Change in daytime symptom score compared to baseline 
 Withdrawal due to asthma exacerbation 
 Requiring one or more courses of oral prednisolone for asthma exacerbation (number of patients) 
 Incidence of oropharyngeal side effects 
 Incidence of oropharyngeal Candidasis
Notes No reply form author to clarify details of randomisation method.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear