Turpeinen 2008.
Methods | Design: single‐centre, randomised, open‐label, parallel‐group, controlled trial Sponsor: Helsinki University Central Hospital and AstraZeneca |
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Participants | Setting: Helsinki University Central Hospital Eligible: 193 Randomly assigned: 59 (continuous budesonide); 58 (budesonide/placebo); 61 (disodium cromoglycate) Analysed (for growth): 52 (continuous budesonide); 46 (budesonide/placebo); 44 (disodium cromoglycate) Gender (male): 59.7% Age, years, mean (range): 6.9 (5‐10) Inclusion criteria: children 5‐10 years of age with symptoms such as wheezing, prolonged cough or shortness of breath, suggesting asthma for at least 1 month before study entry and with significant bronchial reversibility. According to symptoms and lung function tests, most children could be categorised as having mild persistent asthma Exclusion criteria: children with acute asthma; an FEV1 < 50% predicted value; treatment during preceding 2 months with ICS, cromones, leukotriene modifiers or long‐acting beta2‐agonists; total cumulative doses of previously used ICS > 36 mg, nasal corticosteroids > 12 mg or > oral doses equivalent to 200 mg prednisolone Previous regular use of ICS: cumulative doses < 36 mg |
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Interventions | Test group:
Control group:
Budesonide was given via Turbuhaler, and cromoglycate was given via MDI. Treatment duration was 18 months |
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Outcomes |
Height was measured at each clinic visit using a stadiometer (Holtain, Crymych, UK) following a standardised procedure |
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Notes | For the budesonide treatment groups, treatment compliance was recorded using a home spirometer, which recorded peak inspiratory flow via Turbuhaler each time a dose of the drug was taken. In the DSCG group, the returned MDI drug canisters were counted and weighed every 3 months. Compliance rate was not reported. Mean treatment compliance for the 3 treatment groups decreased linearly from an initial level of approximately 90% to a mean level of approximately 60% towards the end of the study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Generated by a computer programme |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label |
Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawal rate was 6/59 (10.2%) in the budesonide group and 16/61 (26.2%) in the cromoglycate 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 |