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Published on: November 4, 2010
Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma
Hans Bisgaard1, Stefen Zielen, María Luz Garcia-Garcia
1Department of Pediatrics, Copenhagen University Hospital, DK-2920 Gentofte, Copenhagen, Denmark. Bisgaard@copsac.dk
Insights
Montelukast significantly reduced asthma exacerbations in young children with intermittent asthma by 31.9% over 12 months. This treatment also delayed the time to the first exacerbation, offering a protective effect against viral-induced asthma attacks.
Area of Science:
- Pediatric Pulmonology
- Allergy and Immunology
- Pharmacology
Background:
- Asthma exacerbations in young children are often triggered by viral infections.
- Intermittent asthma symptoms in children aged 2-5 years require effective preventive strategies.
Purpose of the Study:
- To evaluate the efficacy of montelukast in preventing viral-induced asthma exacerbations in children aged 2 to 5 years.
- To assess the impact of montelukast on symptom frequency and healthcare resource utilization.
Main Methods:
- A 12-month, multicenter, double-blind, placebo-controlled study.
- 278 children received montelukast (4-5 mg daily), and 271 received a placebo.
- Caregivers maintained daily diary cards for symptom tracking and resource use.
Main Results:
- Montelukast reduced the rate of asthma exacerbations by 31.9% compared to placebo (1.60 vs. 2.34 episodes/year).
- Montelukast significantly delayed the median time to the first exacerbation by approximately 2 months (p=0.024).
- A significant reduction in the rate of inhaled corticosteroid courses was observed with montelukast (p=0.027).
Conclusions:
- Montelukast is effective in reducing asthma exacerbations in 2- to 5-year-old children with intermittent asthma.
- The drug demonstrates a favorable safety profile and tolerability over 12 months of treatment.
- Montelukast offers a valuable therapeutic option for managing viral-induced asthma exacerbations in this pediatric population.
Abstract:
The PREVIA study was designed to investigate the role of montelukast, a leukotriene receptor antagonist, in the prevention of viral-induced asthma exacerbations in children aged 2 to 5 years with a history of intermittent asthma symptoms. The study was a 12-month multicenter, double-blind, parallel-group study of patients with asthma exacerbations associated with respiratory infections and minimal symptoms between episodes. Patients were randomized to receive oral montelukast 4 or 5 mg (depending on age) (n = 278) or placebo (n = 271) once per day for 12 months. Caregivers recorded children's symptoms, beta-agonist use, and health care resource use in a diary card. Over 12 months of therapy, montelukast significantly reduced the rate of asthma exacerbations by 31.9% compared with placebo. The average rate of exacerbation episodes per patient was 1.60 episodes per year on montelukast compared with 2.34 episodes on placebo. Montelukast also delayed the median time to first exacerbation by approximately 2 months (p = 0.024), and the rate of inhaled corticosteroid courses (p = 0.027) compared with placebo. Montelukast effectively reduced asthma exacerbations in 2- to 5-year-old patients with intermittent asthma over 12 months of treatment and was generally well tolerated.
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