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A Randomized, Double-blind Trial

Barbara Knorr, MD; Jonathan Matz, MD; Jonathan A. Bernstein, MD; Ha Nguyen, PhD; Beth C. Seidenberg, MD; Theodore F. Reiss, MD; Allan Becker, MD; for the Pediatric Montelukast Study Group

JAMA. 1998;279:1181-1186.

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 -agonist administration, a minimal predefined level of daytime asthma symptoms, and daily -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.

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).

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