Early control treatment with montelukast in preschool children with asthma: A randomized controlled trial

Publication date: Available online 16 May 2017
Source:Allergology International
Author(s): Mizuho Nagao, Masanori Ikeda, Norimasa Fukuda, Chizu Habukawa, Tetsuro Kitamura, Toshio Katsunuma, Takao Fujisawa
BackgroundWhile 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.MethodsEligible 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.ResultsFrom 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).ConclusionsMontelukast 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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