Toogood 1990.
Methods | Setting: Canada, hospital outpatient clinic Length of intervention period: 8 weeks Randomation: yes, computer generated random number sequence Allocation concealment: unclear Design: parallel Masking: double blind Excluded: stated (3 patients whose asthma control could not be stabilised) Withdrawals: stated Baseline characteristics: comparable Jadad score=5 | |
Participants | 32 adults: 19M 13F Mean (SD) age: BUD 52.4(13.6) years, placebo 53.6(16.4) years Inclusion criteria: Adults with asthma as defined by history of variable wheezing and dyspnoea relieved by beta2 agonists, diffuse wheezing on ausculation Exclusion criteria: Regular oral steroid treatment Patients not well controlled at the end of baseline | |
Interventions | BUD: 100 mcg 1 puff 4xdaily (400 mcg/d) Placebo: 1 puff 4xdaily Delivery device: MDI+spacer (extendible tube, 110ml) |
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Outcomes | Time to relapse (days) | |
Notes | Reply from author to clarify method of random order generation and blinding. During the 4 week run in period , patients were aggressively treated with BDP to achieve maximum control of asthma. A priori defined criteria for asthma relapse: time to point at which 7‐day mean lower morning and evening PEFR (LPFD) fell below 95% CI for LPFD at baseline. This study also included an oral budesonide treatment arm: results not considered in this systematic review. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |