Pirozynski 1996.
Methods | Study Design: Parallel RCT Randomisation: random stated, method not described Concealment of Allocation: Not stated Double Blinding: Yes Withdrawals / dropouts: Described Adverse events: Not described Statistical analysis: Not described Jadad Score: 3 | |
Participants | Study site: Not stated
No eligible: Not stated
No randomised: 262
No completed: 23 withdrew due to exacerbation or adverse event, ? number completed.
Sex: Females: 143 (55%); Males: 119 (45%)
Age: Mean 36yrs
Diagnostic criteria for asthma: Not stated
Inclusion criteria: Not stated Exclusion criteria: Not stated Baseline severity of asthma: mild‐to‐moderate asthma. Mean FEV1 % predicted: 82.3%. Mean PEF: 380 L/min |
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Interventions | 1: BUD 800mcg/day (400mcg bd) for 4 weeks then reduced to 200mcg/day (100mcg bd) for a further 8 weeks
2: BUD 200mcg/day (100mcg bd) for 12 weeks Delivery device: DPI Duration of treatment: 12 weeks Run in phase: 2 weeks Other: |
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Outcomes | Withdrawal due to exacerbations or adverse events, PEF, FEV1, rescue medications, symptoms | |
Notes | Abstract only | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised; other information not available |