Mizuho Nagao1, Masanori Ikeda2, Norimasa Fukuda3, Chizu Habukawa4, Tetsuro Kitamura5, Toshio Katsunuma6, Takao Fujisawa7. 1. Allergy Center, Mie National Hospital, Tsu, Japan. 2. Department of Pediatrics, Fukuyama Medical Center, Fukuyama, Japan. 3. Grimm Pediatric Clinic, Shimotsuke, Japan. 4. Department of Pediatrics, Minami Wakayama Medical Center, Tanabe, Japan. 5. Department of Pediatrics, Nippon Kokan Fukuyama Hospital, Fukuyama, Japan. 6. Department of Pediatrics, Tsunan Hospital, Tsunan, Japan; Department of Pediatrics, Jikei University Daisan Hospital, Tokyo, Japan. 7. Allergy Center, Mie National Hospital, Tsu, Japan. Electronic address: fujisawa@mie-m.hosp.go.jp.
Abstract
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.
RCT Entities:
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.
Authors: César Muñoz; Lissette Guevara; María-Isabel Escamilla; Ronald Regino; Nathalie Acevedo; Jose Miguel Escamilla-Arrieta Journal: Front Allergy Date: 2021-10-28