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. 2004 Apr 19;2004(2):CD004109. doi: 10.1002/14651858.CD004109.pub2

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
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:
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