PURPOSE OF THE STUDY.
Though montelukast therapy is an approved treatment for children, few studies have investigated its efficacy in young children who wheeze. This study aimed to determine the effectiveness, in terms of symptoms-free days and lung function, of montelukast as a monotherapy in the treatment of recurrent wheezing in children younger than 2 years.
A total of 113 full-term 6- to 24-month-old children (mean age 15.5 months), with at least 1 episode of physician-diagnosed wheezing episode, were included. All study participants must have successfully performed a methacholine challenge test for inclusion in the study. From the 367 patients screened, 254 (72%) did not meet the inclusion criteria. Notably, the study population was also 74% boys. Children who experienced an exacerbation that required steroid treatment or reasons for noncompliance were withdrawn.
After the 2-week run-in period, participants were randomized to receive either montelukast (4-mg oral granule daily) or matching placebo. The treatment intervention was given for 8 weeks and symptoms of wheeze, dyspnea, and use of rescue medication were recorded daily using a visual analog scale ranging from 0 (no symptoms) to 10 (severe symptoms). Measurements of lung function, airway responsiveness to methacholine, and FeNO were collected on 77 (68%) of the 113 participants.
The primary outcome was symptom-free days, which was classified as a visual analog scale score ≤0.5 and no use of rescue albuterol. Mean changes in symptom-free days or use of rescue medication between the montelukast (3.1 to 3.7 days) and placebo (2.7 to 3.1 days) groups in response to treatment were not significant (P = .965).
Contradictory to previous studies, this study reveals that use of montelukast therapy has no effect on symptom-free days, use of rescue medication, exacerbations, or lung function.
The results of the study reported conflicting data to current publications on the efficacy of montelukast treatment in young asthmatic patients to alleviate symptoms and reduce exacerbations. Although current asthma management guidelines (National Asthma Education and Prevention Program and PRACTical ALLergy) recommend the consideration of montelukast therapy for this population, this study suggests otherwise. What is of interest is the phenotypic differentiation made in this wheezy infant population between children with episodic viral and chronic wheeze who exhibit breakthrough symptoms between exacerbations. This characterization is intriguing and further discussion of whether to distinguish this preschool wheezing population based on subgroups could assist in practice and management.
- Copyright © 2013 by the American Academy of Pediatrics