O'Byrne 1996.
Methods | Setting: Canada, multicentre study, primary care Randomisation: yes, by computer‐generated randomisation sequence Allocation concealment: yes (coding undertaken centrally by pharmaceutical company sponsors) Design: parallel Intervention period: 4 months Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=4 | |
Participants | 47 adults: 25M 32F Mean (SD) age: BUD 400 32(9.0) years, BUD 800 37(17.8) years, placebo 36(12.7) years Inclusion criteria: Adults over the age of 18 with asthma requiring the use of inhaled bronchodilators Diurnal PEFR variability 10% or greater for at least 3 out of 7 days of the screening period Exclusion criteria: Inhaled or oral steroids in last 3 months Felt to require inhaled corticosteroids by primary care physician at the time of enrolment | |
Interventions | BUD:
1. 100mcg 2pfs 2xdaily (400 mcg/d)
2. BUD 200mcg 2pfs 2xdaily (800 mcg/d) Placebo: 2 pfs 2xdaily Delivery device: MDI+spacer |
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Outcomes | Change in morning PEFR compared to baseline Change in evening PEFR compared to baseline % of patients reporting: any symptoms; waking at night; waking early due to asthma; requiring bronchodilators > 4xdaily during previous month No. of patients attending hospital emergency dept due to acute asthma exacerbation Withdrawal due to asthma exacerbation Economic analysis | |
Notes | Reply from author confirming use of allocation concealment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |