Jonasson 2000.

Methods	Design: single‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: AstraZeneca AS
Participants	Setting: Ulleval University Hospital, Oslo, Norway Eligible: not reported Randomly assigned: 28 (BUD 100 μg+placebo); 32 (BUD 200 μg+placebo); 28 (BUD 100 μg+BUD 100 mcg); 34 (placebo+placebo) Gender (male): 65.6% Age, years, mean: 9.7 Inclusion criteria: children with mild asthma, diagnosed according to International Consensus report and Nordic Consensus report; 3 previous obstructive episodes or 1 previous obstructive episode with atopy; at least 1 of these episodes had to have occurred within the last year before randomisation Exclusion criteria: patients who had used inhaled steroids within 2 months, or cromoglycate and/or nedocromil within 4 weeks, of entry Previous regular use of ICS: not allowed
Interventions	Test group: Budesonide, 100 μg (morning)+placebo (evening) Budesonide, 200 μg (morning)+placebo (evening) Budesonide, 100 μg (morning)+budesonide 100 μg (evening) Control group: Placebo (morning)+placebo (evening) Treatment was given twice daily via Turbuhaler inhaler for 27 months
Outcomes	Linear growth velocity (cm/y) Exercise‐induced bronchoconstriction Methacholine hyperreactivity Number of blood eosinophils Participant height was measured at every visit throughout the study period by a wall‐fixed stadiometer. 3 trained persons carried out all height measurements during the study
Notes	Study was the direct continuation of a previous 12‐week trial. Treatment compliance was assessed by counting the remaining doses in the inhaler device, which initially contained 200 doses. This was done at every 6‐month interval or when the inhalers were returned. Compliance rate ranged from 52%‐59%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details provided
Allocation concealment (selection bias)	Unclear risk	No details provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Use of matching placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Use of matching placebo
Incomplete outcome data (attrition bias) All outcomes	High risk	Withdrawal rate was 20/88 (25%) in the budesonide groups and 13/34 (38.2%) in the placebo group
Selective reporting (reporting bias)	Low risk	Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified
Other bias	Low risk	Study appears to be free of other sources of bias