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Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial
Mizuho Nagao1, Masanori Ikeda2, Norimasa Fukuda3
1Allergy Center, Mie National Hospital, Tsu, Japan.
Insights
Montelukast significantly reduced asthma exacerbations in young children compared to as-needed medication. This finding supports its use as an effective control treatment for preschool asthma.
Area of Science:
- Pediatric Pulmonology
- Clinical Trials
- Asthma Management
Background:
- Discrepancies exist between Japanese and Western guidelines regarding initial asthma control treatment for preschool children.
- Japanese guidelines recommend proactive control therapy for children with frequent asthma symptoms, while Western guidelines do not.
Purpose of the Study:
- To compare the efficacy of montelukast as a control treatment versus as-needed beta2-agonists in preschool children with asthma.
- To evaluate the impact of daily montelukast on asthma exacerbations and the need for step-up therapy.
Main Methods:
- A randomized controlled trial involving 93 children aged 1-5 years with asthma symptoms occurring 1-3 times per month.
- Participants were randomized to receive either 4mg of montelukast daily or as-needed beta2-agonists for 48 weeks.
- The primary endpoint was the occurrence of acute asthma exacerbations requiring inhaled corticosteroid initiation.
Main Results:
- The montelukast group experienced significantly fewer acute asthma exacerbations (13 patients, 28%) compared to the no-controller group (23 patients, 50%) (P=0.027).
- Mean exacerbations per year were lower in the montelukast group (0.9) versus the no-controller group (1.9).
- Fewer patients in the montelukast group required step-up treatment with inhaled corticosteroids (10 patients, 21%) versus the no-controller group (19 patients, 41%) (P=0.033).
Conclusions:
- Montelukast demonstrates effectiveness as a control treatment for preschool children experiencing asthma symptoms more than once a month but less than weekly.
- Daily montelukast therapy can reduce asthma exacerbations and the need for escalating treatment in this pediatric population.
Background:
While Japanese guideline recommends initial control treatment for preschool children with asthma symptoms more than once a month, Western guidelines do not. To determine whether control treatment with montelukast was more effective than as-needed β2-agonists in this population, we conducted a randomized controlled trial.
Methods:
Eligible patients were children aged 1-5 years who had asthma symptoms more than once a month but less than once a week. Patients were randomly assigned in a 1:1 ratio to receive montelukast 4 mg daily for 48 weeks or as-needed β2-agonists. The primary endpoint was the number of acute asthma exacerbations before starting step-up treatment with inhaled corticosteroids. This study is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000002219.
Results:
From September 2009 to November 2012, 93 patients (47 in the montelukast group and 46 in the no-controller group) were enrolled into the study. All patients were included in the analysis. During the study, 13 patients (28%) in the montelukast group and 23 patients (50%) in the no-controller group had acute exacerbations with the mean numbers of 0.9 and 1.9/year, respectively (P = 0.027). In addition, 10 (21%) and 19 (41%) patients received step-up treatment, respectively. Cumulative incidence of step-up treatment was significantly lower in the montelukast group (hazard ratio 0.45, 95% confidence interval 0.21 to 0.92; P = 0.033).
Conclusions:
Montelukast is an effective control treatment for preschool children who had asthma symptoms more than once a month but less than once a week.
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