TY - JOUR
T1 - Early control treatment with montelukast in preschool children with asthma
T2 - A randomized controlled trial
AU - on behalf of the
AU - LePAT (Leukotriene and Pediatric Asthma Translational Research Network) investigators
AU - Nagao, Mizuho
AU - Ikeda, Masanori
AU - Fukuda, Norimasa
AU - Habukawa, Chizu
AU - Kitamura, Tetsuro
AU - Katsunuma, Toshio
AU - Fujisawa, Takao
AU - Tokuyama, Kennichi
AU - Terada, Akihiko
AU - Sato, Kazuki
AU - Miura, Katsushi
AU - Arakawa, Hirokazu
AU - Zaitsu, Masafumi
AU - Sakamoto, Tastuo
AU - Takamasu, Tetsuya
AU - Shimojo, Naoki
AU - Kameda, Makoto
AU - Mochizuki, Hiroyuki
AU - Tachimoto, Hiroshi
AU - Yamaguchi, Koichi
AU - Masuda, Kei
AU - Adachi, Yuichi
AU - Oshima, Yusei
AU - Yoshihara, Shigemi
AU - Tanaka, Noriko
AU - Ohta, Kunitaka
AU - Morita, Masao
AU - Tokuda, Reiko
AU - Kitou, Yoshihiko
AU - Araki, Hayao
AU - Yamaoka, Akiko
AU - Nakamura, Akio
N1 - Funding Information:
This study was sponsored by the Waxman Foundation of Japan Inc . The sponsor had no role in study design; collection, analysis, or interpretation of the data; or writing of the report. The authors express sincere appreciation to the LePAT investigators listed below: Kennichi Tokuyama (Saitama Medical Univeristy), Akihiko Terada (Terada Allergy and Pediatric Clinic), Kazuki Sato (Shimoshizu National Hospital), Katsushi Miura (Miyagi Prefectural Children's Hospital), Hirokazu Arakawa (Gunma University), Masafumi Zaitsu (Saga University), Tastuo Sakamoto (Chukyo University), Tetsuya Takamasu (Kanagawa Prefectural Children's Medical Center), Naoki Shimojo (Chiba University), Makoto Kameda (Osaka Prefectural Respiratory and Allergy Medical Center), Hiroyuki Mochizuki (Tokai University), Hiroshi Tachimoto (Jikei University), Koichi Yamaguchi (Doai Fraternal Hospital), Kei Masuda (Doai Fraternal Hospital), Yuichi Adachi (Toyama University), Yusei Oshima (University of Fukui), Shigemi Yoshihara (Dokkyo Medical University), Noriko Tanaka (Kurashiki Center Hospital), Kunitaka Ohta (Rokko Island Hospital), Masao Morita (Smile Kids Clinic), Reiko Tokuda (Tokuda Family Clinic), Yoshihiko Kitou (Shinko Hospital), Hayao Araki (Araki Pediatric Clinic), Akiko Yamaoka (Miyagi Prefectural Children's Hospital), and Akio Nakamura (Ohmiya General Hospital). We also thank Yuhei Hamasaki (the former chairman of the LePAT). Writing and editing assistance was provided by Kenichi Hayashi (Alamedic Co., Ltd., Tokyo, Japan) under contract with the principal authors (MN and TF). Appendix A
Funding Information:
TF received lecture fees from GlaxoSmithKline, MSD, Maruho, a payment for his writing a manuscript from AstraZeneka, and research funding from Pfizer. The rest of the authors have no conflict of interest.
Publisher Copyright:
© 2017 Japanese Society of Allergology
PY - 2018/1
Y1 - 2018/1
N2 - 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.
AB - 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.
KW - Asthma
KW - Drug therapy
KW - Montelukast
KW - Pediatrics
KW - Randomized controlled trial
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U2 - 10.1016/j.alit.2017.04.008
DO - 10.1016/j.alit.2017.04.008
M3 - Article
C2 - 28526210
AN - SCOPUS:85019638457
VL - 67
SP - 72
EP - 78
JO - Allergology International
JF - Allergology International
SN - 1323-8930
IS - 1
ER -