Becker 2006.

Methods	Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Merck Research Laboratories
Participants	Setting: 30 medical centres worldwide (Asia, Africa, Europe, North America and South America) Eligible: 575 Randomly assigned: 120 (montelukast 5 mg); 119 (CFC‐beclomethasone 200 μg); 121 (placebo) Analysed: 109 (montelukast 5 mg); 108 (CFC‐beclomethasone 200 μg); 108 (placebo) Gender (male): 64.4% Age, years, mean ± SD: boys 7.71 ± 0.85; girls 7.35 ± 0.56 Inclusion criteria: mild, persistent asthma at step 2 of the Global Initiative for Asthma guidelines and a 6‐month or longer history of asthma; Tanner stage I, with heights and weights in the 5th to 95th percentile range for age as described in the National Center for Health Statistics guidelines; bone age within 2 years of chronological age; pre‐bronchodilator FEV1 at least 75% of predicted Exclusion criteria: severe chronic sinus disease, nasal polyposis, pulmonary disease other than asthma or upper or lower respiratory tract infection; use of the following medications before visit 1: antileukotrienes (within 1 month); nasal, ocular and inhaled corticosteroids (2 weeks‐1 month); oral corticosteroids (4 months); more than 2 courses of inhaled corticosteroids (no course exceeded 14 days) for asthma (12 months); astemizole (3 months); theophylline, nedocromil, cromolyn, long‐acting beta2‐agonists and antimuscarinics (4 weeks); methylphenidate, thyroid hormone, growth hormone, anabolic corticosteroids, calcitonin, estrogens, progestins, bisphosphonates, anticonvulsants and phosphate‐binding antacids (any time before visit 1) Previous regular use of ICS: < 14 days
Interventions	Test group: Montelukaste, 5 mg/d CFC‐beclomethasone, 400 μg/d Control group: matching placebos Beclomethasone and matching placebo were delivered twice daily via a CFC‐MDI with spacer. Montelukaste was given once daily. Treatment duration was 56 weeks
Outcomes	Linear growth velocity (cm/y) Change in height over 56 weeks (cm) Change from baseline in markers of bone turnover (serum osteocalcin, ng/mL; urinary N‐telopeptide/creatinine ratio) Height was measured in triplicate in the morning at the same time of day during each visit using a standard stadiometer, every 8 weeks during 56 weeks
Notes	Treatment compliance was measured by tablet counts; canister weight was > 95% in each treatment group Use of systemic corticosteroids for exacerbations: CFC‐beclomethasone 28/119 (23.5%); montelukast 30/120 (25.0%); placebo 42/121 (34.7%)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated, randomised schedule
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 11/119 (9.2%) in the beclomethasone group and 13/121 (10.7%) 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 pre‐specified
Other bias	Low risk	Study appears to be free of other sources of bias