Sorkness 2007.

Methods	Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: National Heart, Lung and Blood Institute
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
Interventions	Test group: Fluticasone 200 μg/d (100 μg in the morning and 100 μg in the evening) plus placebo oral drug in the evening Fluticasone propionate 100 μg/salmeterol 50 μg in the morning and salmeterol 50 μg in the evening plus placebo oral drug in the evening Control group: Matching placebo Diskus in the morning and placebo Diskus in the evening plus montelukast 5 mg in the evening Fluticasone and fluticasone/salmeterol were given via Diskus. Treatment duration was 48 weeks
Outcomes	Percentage of asthma control days Pulmonary function measures Change in height over time (cm)
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