Kannisto 2000.
| Methods | Design: single‐centre, randomised, open‐label, parallel‐group, controlled trial Sponsor: Finnish Foundation for Pediatric Research and Kuopio University Hospital |
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| Participants | Setting: Allergy Unit of the Department of Pediatrics, Kuopio University Hospital, Finland Eligible: not reported Randomly assigned: 30 (fluticasone); 30 (budesonide); 15 (cromones) Gender (male): 48% Age, years, mean (range): 9.5 (5.5–14.7) Inclusion criteria: children with newly diagnosed asthma who had started their first period of maintenance medication Exclusion criteria: not reported Previous regular use of ICS: none of the participants |
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| Interventions | Test group:
Control group:
Fluticasone was given via Diskus and budesonide was given via Turbuhaler, twice daily. Cromones were given via MDI with a large volume spacer or via DPI. Treatment duration was 12 months |
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| Outcomes |
Height was measured by an experienced asthma nurse using a calibrated Harpenden stadiometer |
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| Notes | Compliance was assessed by a home monitoring diary in which participants had recorded used medication doses. Compliance rate was not reported | |
| 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 | Unclear risk | No details provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawal reported |
| Selective reporting (reporting bias) | Low risk | Study protocol is not available, but published reports include all expected outcomes, including those that were pre‐specified |
| Other bias | Low risk | Study appears to be free of other sources of bias |