Jonasson 2000.
Methods | Design: single‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: AstraZeneca AS |
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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 |
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Interventions | Test group:
Control group:
Treatment was given twice daily via Turbuhaler inhaler for 27 months |
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Outcomes |
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 |
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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 |