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 |
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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 |