Elsevier

The Journal of Pediatrics

Volume 133, Issue 3, September 1998, Pages 424-428
The Journal of Pediatrics

Montelukast once daily inhibits exercise-induced bronchoconstriction in 6- to 14-year-old children with asthma,☆☆,,★★

https://doi.org/10.1016/S0022-3476(98)70281-1Get rights and content

Abstract

Objective: To determine whether montelukast, a leukotriene receptor antagonist, attenuates exercise-induced bronchoconstriction (EIB) in 6- to 14-year-old children with asthma.

Study design: Double-blind, multicenter, 2-period crossover study. Children (n = 27) with forced expiratory volume in 1 second (FEV1 ) ≥70% of the predicted value and a fall in FEV1 ≥ 20% after exercise on 2 occasions. Patients received montelukast (5-mg chewable tablet) or placebo once daily in the evening for 2 days in crossover fashion (at least 4 days between treatment periods). Standardized exercise challenges were performed 20 to 24 hours after the last dose in each period. End points included area above the postexercise percent fall in FEV1 versus time curve (AAC0-60min ), maximum percent fall in FEV1 from pre-exercise baseline, and time to recovery of FEV1 to within 5% of pre-exercise baseline.

Results: Montelukast significantly reduced AAC0-60min (265 vs 590 % · min for montelukast and placebo, respectively, P ≤ .05; ~59% protection relative to placebo) and the maximum percent fall (18% vs 26% for montelukast and placebo, respectively, P ≤ .05). Montelukast treatment resulted in a shorter time to recovery (18 vs 28 minutes for montelukast and placebo, respectively, P = .079).

Conclusions: Montelukast attenuates EIB at the end of the dosing interval in 6- to 14-year-old children with asthma. (J Pediatr 1998;133:424-8)

Section snippets

Patients

Healthy, stable, nonsmoking, outpatients aged 6 to 14 years with a history of typical symptoms of asthma were enrolled (Table I). Eligibility for randomization included a pre-exercise forced expiratory volume in 1 second (at least 70% of the predicted value [after withholding short-acting, inhaled β-agonist for 6 hours]) and a 20% or greater decrease in FEV1 after a standardized treadmill exercise challenge during each of 2 prestudy (prerandomization) visits.

Patients were excluded from the

Patient Demographics

Twenty-seven patients with asthma, 20 male and 7 female, were enrolled; 25 patients completed the study and were included in the analyses (Table I). Two patients (both receiving placebo) were discontinued from the study; one patient was discontinued because of an asthma exacerbation requiring oral corticosteroid treatment, and one patient was discontinued because of a protocol deviation. Other than β-agonists, no additional asthma medications were used during the course of the study.

Efficacy

There were

Discussion

We report protection against EIB by a leukotriene receptor antagonist in 6- to 14-year-old children with asthma. Montelukast (5-mg chewable tablet) demonstrated protection against EIB at the end of a once daily dosing interval in 6- to 14-year-old children, as evidenced by a significant reduction in AAC0-60min and maximum percent fall in FEV1 and by a borderline significant decrease in the time to recovery to within 5% of pre-exercise FEV1 . Although not evaluated in this study, it is likely

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    From Allergy and Asthma Medical Group and Research Center, San Diego, California; International Medical Technical Consultants, Inc, Prairie Village, Kansas; ASTHMA, Inc, Seattle, Washington; and Merck & Co, Inc, Rahway, New Jersey.

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    Conflict of Interest Statement: Supported by a grant from Merck Research Laboratories. Ha H. Nguyen, PhD, Theodore F. Reiss, MD, Beth C. Seidenberg, MD, and Barbara Knorr, MD, are employees of Merck & Co, Inc and hold stock in Merck & Co, Inc. James P. Kemp, MD, Robert J. Dockhorn, MD, and Gail G. Shapiro, MD, are, or have served as, consultants for, or received honorariums or research grants from, Merck & Co, Inc.

    Reprint requests: Barbara Knorr, MD, Director, Pulmonary-Immunology, Merck Research Laboratories, Merck and Co, Inc, PO Box 2000, RY33-656, Rahway, NJ 07065.

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