Juniper 1990.
Methods | Setting: Canada, hospital outpatient clinic Randomisation: yes, method not stated Allocation concealment: yes Design: parallel Intervention period: 12 months Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=4 | |
Participants | 32 adults: 13M 19F Mean (SD) age: budesonide 42.4(11.6) years, placebo 35.1(15.8) years Inclusion criteria: Clinical diagnosis of asthma Methacholine BHR (PC20 FEV1) <8mg/ml FEV1 (% predicted) 70 or greater Exclusion criteria: Use of inhaled or oral steroids or cromoglycate within last 6 weeks Pregnancy | |
Interventions | BUD: 200 mcg 1 pf 2xdaily (400mcg/d) Placebo: 1 pf 2xdaily Dlievery device: MDI+spacer |
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Outcomes | FEV1 (% predicted) Methacholine BHR (PC20 FEV1) Asthma severity score Daily beta2 agonist use No. of asthma exacerbations 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 | Reply from author confirming use of allocation concealment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |