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

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)
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