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. 2014 Jul 16;2014(7):CD009471. doi: 10.1002/14651858.CD009471.pub2

Storr 1986.

Methods Design: single‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial
Sponsor: SETRHA and The Royal Alexandra Hospital Centenary Fund
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
Interventions Test group:
  • Beclomethasone, 300 μg/d


Control group: matching placebo
Treatment was given 3 times daily via jet nebuliser for 6 months
Outcomes
  • Mean daily symptom scores

  • Symptom‐free days

  • Change in height over time (cm)

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