de Benedictis FM, del Giudice MM, Forenza N, Decimo F, de Benedictis D, Capristo A. Eur Respir J. 2006;28:291–295
PURPOSE OF THE STUDY. To evaluate montelukast's ability to inhibit exercise-induced bronchoconstriction in children at various time points over a treatment period of 28 days.
STUDY POPULATION. Thirty-two children, ranging in age from 6 to 12 years, with mild-to-moderate asthma.
METHODS. This study was designed as a multicenter, double-blind, randomized, parallel-group, placebo-controlled study. Subjects received either montelukast 5 mg or a placebo given once daily in the evening for 4 weeks. Exercise challenge and a pulmonary-function test were performed at baseline and then again at days 3, 7, and 28.
RESULTS. Montelukast provided significantly more protection against exercise-induced bronchoconstriction than placebo at each time point after treatment began. In addition, there was no significant difference in the percentage decrease of forced expiratory volume in 1 second for each drug at each of the days measured.
CONCLUSIONS. Montelukast provided significant protection for children with mild-to-moderate asthma against exercise-induced bronchoconstriction for a period of 28 days with no tolerance observed to the medication's effects.
REVIEWER COMMENTS. The results of this study parallel those that were run in adults. Montelukast offered effective protection against exercise-induced bronchoconstriction in children as well. The study also confirmed that long-term use is not required for results to be seen, and the protection conferred does not diminish for at least a 28-day period. Longer studies up to ≥12 weeks, paralleling adult studies, are warranted for further evaluation of montelukast's effects. This study was also limited in its sample size and involved only subjects with mild-to-moderate asthma. It would be worthwhile to determine if montelukast would be of the same benefit to severely asthmatic patients. It should be noted that approximately a quarter of the children in the study were taking inhaled steroids on a regular basis, and these patients responded to montelukast in the same way as those who were not on any such medications. This study makes a case for montelukast to be a preferential therapeutic option in children.
- Copyright © 2007 by the American Academy of Pediatrics