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 |