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

Bisgaard 1993.

Methods Study Design: Crossover RCT
 Randomisation: Random stated method not described. Concealment of Allocation: Not stated
 Double Blinding: No ‐ single blind. 
 Withdrawals / dropouts: Described
 Adverse events: Described Statistical analysis: Described
 Jadad Score: 3
Participants Study site: Outpatients
 No eligible: Not stated. 
 No randomised: 18
 No completed: 14 
 Sex: Males 9 (64%); Females 5 (36%)
 Age: mean 27 months. 
 Diagnostic criteria for asthma: Dr diagnosis 
 Inclusion criteria: < 3 yrs age, recurrent wheeze, previous ICS but not in past month.
 Exclusion criteria: No OCS in past 3 months, exacerbations requiring > 4 puffs beta 2 agonist for > 4 days during study period, temp >38 degrees during study period.
 Baseline severity of asthma: Not stated
Interventions 1: BUD 800mcg /day
 2: BUD 200mcg/day
 3. Placebo
 Delivery device: pMDI plus spacer 
 Duration of treatment: 4wks for each treatment ‐ 12 weeks total.
Run in phase: not stated 
 Wash out phase: no washout between treatments 
 Other: rescue meds prn, no other meds allowed, no glucocorticoid ointments.
Outcomes exacerbations, growth rate, symptoms, rescue meds
Notes No washout period between treatments
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised; other information not available