Montelukast for Chronic Asthma in 6- to 14-Year-Old Children A Randomized, Double-blind Trial
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 β-agonist administration, a minimal predefined level of
daytime asthma symptoms, and daily β-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.
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