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

O'Byrne 1996.

Methods Study Design: Parallel RCT
 Randomisation: Computer generated code‐ stratified by allergy status and randomised in blocks of 3 at each centre
 Concealment of Allocation: coded identical containers 
 Double Blinding: Yes
Withdrawals / dropouts: Described.
 Adverse events: Described.
 Statistical analysis: Intention to treat
 Jadad Score: 4
Participants Study site: multicentre trial in 7 cities, at primary care physicians
 No eligible: Not stated
 No randomised: 57 (20/17/20)
 No completed: 39 (12/13/14)
 Sex: Male 25
 Female 32
 Age: mean 37/32/36 
 Diagnostic criteria for asthma: Objective lung function:> 10% PEF diurnal variation at least 3 of the last 7 days.
 Inclusion criteria: > 18 years, mild asthma and on clinical evaluation not requiring ICS. 
 Exclusion criteria: No ICS in past 3 months, Requiring ICS
 Baseline severity of asthma: PEF mean (SD): Intervention 1: 364 (115); Intervention 2: 381 (112); Intervention 3 : 403 (116)
Interventions 1: BUD 800mcg/day (400mcg bid)
 2: BUD 400mcg /day (200mcg bid)
 3: Placebo
 Delivery device: nebuhaler
 Duration of treatment: 16 weeks 
 Run in phase: 
 Other: Beta agonists as needed, theophylline if remained constant through out study, allowed budesonide and/or prednisone for exacerbation during study.
Outcomes costs, hospitalisations, ER visits, PEF, symptoms, exacerbations, adverse events
Notes For morning PEF it was assumed the variance estimate was SE.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated code‐ stratified by allergy status and randomised in blocks of 3 at each centre