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


METHODS
Eight-week, multicenter, randomized, double-blind study.


METHODS
Forty-seven outpatient centers at private practices and academic medical centers in the United States and Canada.


METHODS
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.


METHODS
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.


METHODS
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).


CONCLUSIONS
Montelukast improves morning FEV1 in 6- to 14-year-old children with chronic asthma.
Knorr
B
B
Department of Pulmonary-Immunology, Merck Research Laboratories, Rahway, NJ 07065, USA.
Matz
J
J
Bernstein
J A
JA
Nguyen
H
H
Seidenberg
B C
BC
Reiss
T F
TF
Becker
A
A
D000085:Acetates / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use; D000704:Analysis of Variance; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002908:Chronic Disease; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D020024:Leukotriene Antagonists; D008297:Male; D011804:Quinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D013440:Sulfides
D000085:Acetates; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast