Montelukast in asthmatic patients 6 years-14 years old with an FEV1 > 75%.
OBJECTIVE
Montelukast is a potent leukotriene receptor antagonist effective for treating asthma symptoms in adult and pediatric patients. The purpose of this analysis was to assess the clinical efficacy of montelukast, a potent leukotriene-receptor antagonist, in a subgroup analysis of patients aged 6 years-14 years with milder asthma, defined as a percentage predicted forced expiratory volume in 1 s (FEV1) > 75% using data from a clinical trial of pediatric patients with a broad range of asthma severities.


METHODS
The original previously published clinical trial was an 8-week multi-center, randomized, double-blind, parallel-group study conducted in 47 centers in the United States and Canada. The study compared the efficacy of once daily montelukast 5 mg to placebo in patients 6 years-14 years old with persistent asthma and an FEV1 ranging from 50% to 85% of predicted. A total of 87 patients in the montelukast group and 51 patients in the placebo group were selected from the original cohort of 336 patients based on percentage predicted FEV1 of > 75%. The primary endpoint was percentage change in FEV1 from baseline compared with placebo over 8 weeks of active treatment.


RESULTS
Montelukast significantly improved the primary endpoint of percentage change in FEV1 compared with placebo (p = 0.005). Other efficacy endpoints were significantly improved on montelukast similar to efficacy in the original study.


CONCLUSIONS
Montelukast significantly improved FEV1, clinic measured peak expiratory flow (PEF), reduced nocturnal awakenings, and improved quality of life in children with milder persistent asthma defined as an FEV1 > 75% of predicted.
Section of Allergy and Clinical Immunology, Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Canada. becker@Ms.UManitoba.CA
Allan
A
Becker
Arlene
A
Swern
Carol A
CA
Tozzi
Qinfen
Q
Yu
Theodore
T
Reiss
Barbara
B
Knorr
D000085:Acetates / Q000494:pharmacology / Q000627:therapeutic use*; D000293:Adolescent; D018927:Anti-Asthmatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D002648:Child; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D010919:Placebos; D011804:Quinolines / Q000494:pharmacology / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D010919:Placebos; D011804:Quinolines; D013440:Sulfides; C093875:montelukast