Sorkness 2007.
Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: National Heart, Lung and Blood Institute |
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Participants | Setting: multi‐centres in the USA Eligible: 648 Randomly assigned: 96 (fluticasone 100 μg); 94 (fluticasone 100 μg/salmeterol 50 μg); 95 (montelukast 5 mg) Analysed: 86 (fluticasone 100 μg); 81 (fluticasone 100 μg/salmeterol 50 μg); 83 (montelukast 5 mg) Gender (male): 61.4% Age, years, mean ± SD: fluticasone 9.8 ± 2; fluticasone+salmeterol 10.3 ± 2.1; montelukast 9.6 ± 2.2 Inclusion criteria: children 6 to younger than 14 years of age with physician‐diagnosed mild to moderate persistent asthma; ability to perform reproducible spirometry; FEV1 ≥ 80% predicted normal at screening and ≥ 70% predicted normal at random assignment; methacholine FEV1 PC20 ≤ 12.5 mg/mL Exclusion criteria: respiratory tract infection, asthma exacerbation or systemic corticosteroid use within 4 weeks; 2 or more asthma hospitalisations in the past year; history of a life‐threatening asthma exacerbation; ≥ 4 courses of systemic corticosteroids in the past year; cigarette smoking within the past year; pregnancy or lactation; failure to practice abstinence or to use a medically acceptable birth control method; history of adverse reactions to PACT medications Previous regular use of ICS: 60.4% in the fluticasone group; 51.1% in the fluticasone+salmeterol group; 57.9% in the montelukast group |
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Interventions | Test group:
Control group:
Fluticasone and fluticasone/salmeterol were given via Diskus. Treatment duration was 48 weeks |
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Outcomes |
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Notes | Treatment compliance was measured by dose indicator. Compliance rate ranged from 86% to 97.7% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was stratified by study centre, and within each centre, a stratified randomisation scheme was applied on the basis of bronchodilator response, race (white or non‐white) and methacholine test |
Allocation concealment (selection bias) | Unclear risk | No details provided |
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 | Withdrawal rate was 10/96 (10.4%) in the fluticasone group and 12/95 (12.6%) in the montelukast 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 |