PMID: 9555757Apr 29, 1998Paper

Montelukast for chronic asthma in 6- to 14-year-old children: a randomized, double-blind trial. Pediatric Montelukast Study Group

JAMA : the Journal of the American Medical Association
B KnorrA Becker

Abstract

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. To determine the clinical effect of montelukast, a leukotriene receptor antagonist, in 6- to 14-year-old children with asthma. Eight-week, multicenter, randomized, double-blind study. Forty-seven outpatient centers at private practices and academic medical centers in the United States and Canada. 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. 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. Morning FEV1 ...Continue Reading

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