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 |
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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 |