Montelukast for Chronic Asthma in 6- to 14-Year-Old Children

A Randomized, Double-blind Trial

Knorr, Barbara MD
Matz, Jonathan MD
Bernstein, Jonathan A. MD
Nguyen, Ha PhD
Seidenberg, Beth C. MD
Reiss, Theodore F. MD
Becker, Allan MD

Pediatric Montelukast Study Group. From the Departments of Pulmonary-Immunology (Drs Knorr, Seidenberg, and Reiss) and Biostatistics (Dr Nguyen), Merck Research Laboratories, Rahway, NJ; Atlantic Asthma and Allergy Center, Inc, Baltimore, Md (Dr Matz); Bernstein Allergy Group, Inc, Cincinnati, Ohio (Dr Bernstein); and Section of Allergy and Clinical Immunology, Department of Pediatrics, University of Manitoba, Winnipeg (Dr Becker).

JAMA: The Journal of the American Medical Association 279(15):p 1181-1186, April 15, 1998.

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 bedtime 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.

JAMA.1998;279:1181-1186