Martinez 2011.
Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: National Heart, Lung and Blood Institute, USA |
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Participants | Setting: 5 clinical centres in the USA Eligible: 843 Randomly assigned: 71 (combined group); 72 (daily beclomethasone); 71 (rescue beclomethasone); 74 (placebo) Gender (male): 159/288 (55.2%) Age, years, mean ± SD: combined 11.4 ± 3.1; daily beclomethasone 10.8 ± 3.5; rescue beclomethasone 10.4 ± 2.8; placebo: 10.4 ± 3.2 Inclusion criteria: children and adolescents between 6 and 18 years of age; history of mild persistent asthma during the previous 2 years; naive to controller treatment with a history of 1 to 2 exacerbations in the previous year; treated for the previous 8 weeks with a monotherapy other than inhaled corticosteroids; illness controlled for the previous 8 weeks on low‐dose corticosteroids as monotherapy (≤ 160 μg daily with a beclomethasone equivalent) Exclusion criteria: participants excluded from the study if they had a pre‐bronchodilator FEV1 less than 60% predicted at first visit; admitted to hospital for asthma in the previous year; any asthma exacerbation in the previous 3 months or more than 2 in the previous year; history of life‐threatening asthma exacerbations that required intubation or mechanical ventilation, or that resulted in a hypoxic seizure Previous regular use of ICS: ranged from 72%‐82% among treatment groups |
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Interventions | Test group:
Control group: placebo: twice‐daily placebo with placebo plus albuterol as rescue Daily treatment was given twice daily via HFA‐MDI. Rescue treatment was given via HFA‐MDI for symptom relief. Treatment duration was 44 weeks |
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Outcomes |
Method for height measure was not reported |
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Notes | Treatment compliance was not measured | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Data Coordinating Center (DCC; Penn State Hershey College, PA, USA) generated the random allocation sequence |
Allocation concealment (selection bias) | Low risk | Central allocation |
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 30/214 (14.0%) in the active treatment groups and 24/74 (32.4%) 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 | Unclear risk | Method of height measure not reported |