Becker 2006.
Methods | Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Merck Research Laboratories |
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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 |
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Interventions | Test group:
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 |
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Outcomes |
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 |
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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%) |
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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 |