Montelukast for chronic asthma in 6- to 14-year-old children: a randomized, double-blind trial. Pediatric Montelukast Study Group
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B Knorr1, J Matz, J A Bernstein
1Department of Pulmonary-Immunology, Merck Research Laboratories, Rahway, NJ 07065, USA.
Insights
Montelukast significantly improved lung function in children with asthma. This study shows montelukast is an effective treatment for pediatric asthma, enhancing morning FEV1 in young patients.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Trials
Background:
- Leukotrienes are key mediators in asthma, causing bronchoconstriction and airway inflammation.
- Previous studies showed leukotriene blockers benefit adults and adolescents with asthma.
- Children under 12, a demographic with high asthma prevalence, lacked targeted studies.
Purpose of the Study:
- To evaluate the clinical efficacy of montelukast, a leukotriene receptor antagonist.
- To assess montelukast's effect on lung function in children aged 6 to 14 with asthma.
Main Methods:
- An 8-week, multicenter, randomized, double-blind, placebo-controlled study.
- 336 children (6-14 years) with moderate-to-severe asthma participated.
- Patients received either 5mg montelukast or placebo daily, with morning FEV1 as the primary outcome.
Main Results:
- Montelukast group showed an 8.23% increase in morning FEV1 from baseline.
- Placebo group showed a 3.58% increase in morning FEV1 from baseline.
- The difference between groups was statistically significant (P<.001).
Conclusions:
- Montelukast effectively improves morning FEV1 in children aged 6-14 with chronic asthma.
- This study supports montelukast as a viable treatment option for pediatric asthma management.
Context:
Leukotrienes are important mediators of asthma by causing bronchoconstriction, mucous secretion, and increased vascular permeability. Studies using compounds that block leukotrienes have demonstrated improvement in asthma control in adults and adolescents, but children younger than 12 years, for whom asthma is the most common chronic disease, have not been studied.
Objective:
To determine the clinical effect of montelukast, a leukotriene receptor antagonist, in 6- to 14-year-old children with asthma.
Design:
Eight-week, multicenter, randomized, double-blind study.
Setting:
Forty-seven outpatient centers at private practices and academic medical centers in the United States and Canada.
Patients:
A total of 336 children with forced expiratory volume in 1 second (FEV1) between 50% to 85% of the predicted value, at least 15% reversibility after inhaled beta-agonist administration, a minimal predefined level of daytime asthma symptoms, and daily beta-agonist use. Concomitant inhaled corticosteroids at a constant daily dose were used by 39% of patients receiving montelukast and 33% receiving placebo.
Intervention:
After a 2-week placebo run-in period, patients received either montelukast (5-mg chewable tablet) or matching-image placebo once daily at bed-time for 8 weeks.
Main Outcome Measure:
Morning FEV1 percent change from baseline.
Results:
Mean morning FEV1 increased from 1.85 L to 2.01 L in the montelukast group and from 1.85 L to 1.93 L in the placebo group. This represents an 8.23% (95% confidence interval [CI], 6.33% to 10.13%) increase from baseline in the montelukast group and a 3.58% (95% CI, 1.29% to 5.87%) increase from baseline in the placebo group (P<.001 for montelukast vs placebo).
Conclusion:
Montelukast improves morning FEV1 in 6- to 14-year-old children with chronic asthma.
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