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Intermittent or daily montelukast versus placebo for episodic asthma in children
Erkka Valovirta1, Maria L Boza, Colin F Robertson
1Allergy Clinic, Suomen Terveystalo AllergyClinic, Turku, Finland. erkka.valovirta@terveystalo.com
Insights
Montelukast did not prevent asthma attacks in young children, despite some symptom improvements. This study evaluated daily versus episode-driven montelukast for episodic asthma in children aged 6 months to 5 years.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Trials
Background:
- Severe intermittent (episodic) asthma in children lacks a standard optimal treatment.
- Montelukast shows potential efficacy for this asthma phenotype, both daily and episode-driven.
Purpose of the Study:
- To evaluate the efficacy of different montelukast regimens for pediatric episodic asthma.
- Compare daily versus episode-driven montelukast administration in children aged 6 months to 5 years.
Main Methods:
- A 52-week, multicenter, randomized, double-blind, double-dummy, parallel-group study.
- Compared placebo with two montelukast 4 mg regimens: daily or episode-driven (12 days).
- Primary outcome: number of asthma episodes culminating in an asthma attack.
Main Results:
- No significant difference in asthma attacks between montelukast regimens and placebo.
- Daily montelukast showed a trend towards reducing symptoms during episodes (P=.045).
- Beta-agonist use decreased with both montelukast regimens compared to placebo.
Conclusions:
- Montelukast did not significantly reduce asthma attacks in young children over one year.
- Numerical improvements in some endpoints were observed, but statistical significance was not met for secondary outcomes.
- All treatments were well-tolerated in the study population.
Background:
No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype.
Objective:
To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma.
Methods:
A multicenter, randomized, double-blind, double-dummy, parallel-group, 52-week study was performed in children 6 months to 5 years of age comparing placebo with two regimens of montelukast 4 mg: (1) daily; or (2) episode-driven for 12 days beginning with signs/symptoms consistent with imminent cold or breathing problem. The main outcome measure was the number of asthma episodes (symptoms requiring treatment) culminating in an asthma attack (symptoms requiring physician visit, emergency room visit, corticosteroids, or hospitalization).
Results:
Five hundred eighty-nine patients were randomized to daily montelukast, 591 to intermittent montelukast, and 591 to placebo. Compared with placebo, no significant difference was seen between daily montelukast (P = .510) or intermittent montelukast (P = .884) in the number of asthma episodes culminating in an asthma attack over 1 year. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P = .045). Beta-agonist use was reduced with both daily (P = .048) and intermittent montelukast (P = .028) compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints cannot be concluded. All treatments were well tolerated.
Conclusions:
Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints.
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