Storr 1986.
Methods | Design: single‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: SETRHA and The Royal Alexandra Hospital Centenary Fund |
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Participants | Setting: Royal Alexandra Hospital for Sick Children, Brighton, UK Eligible: 29 Randomly assigned: 15 (beclomethasone); 14 (placebo) Analysed: 15 (beclomethasone); 13 (placebo) Gender (male): 62.1% Age, years, mean (range): 3.6 (1.6‐5.6) Inclusion criteria: During the 6 months before the study, all had had severe recurrent wheezing episodes and had responded well to treatment with nebulised bronchodilator agents. The number of previous hospital admissions for asthma ranged from 4 to 14, with at least 2 in the previous 6 months. None of the participants were satisfactorily controlled before the study began Exclusion criteria: not reported Previous regular use of ICS: none of the participants |
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Interventions | Test group:
Control group: matching placebo Treatment was given 3 times daily via jet nebuliser for 6 months |
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Outcomes |
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Notes | Treatment compliance was not measured | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details provided |
Allocation concealment (selection bias) | Low risk | Allocation code was kept by the hospital pharmacist and by Allen and Hanburys Ltd |
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 | Low risk | Only 1 participant did not complete the study |
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 | Unclear risk | Method of height measure not reported |