Allergology International (Jan 2018)

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

  • Mizuho Nagao,
  • Masanori Ikeda,
  • Norimasa Fukuda,
  • Chizu Habukawa,
  • Tetsuro Kitamura,
  • Toshio Katsunuma,
  • Takao Fujisawa,
  • Kennichi Tokuyama,
  • Akihiko Terada,
  • Kazuki Sato,
  • Katsushi Miura,
  • Hirokazu Arakawa,
  • Masafumi Zaitsu,
  • Tastuo Sakamoto,
  • Tetsuya Takamasu,
  • Naoki Shimojo,
  • Makoto Kameda,
  • Hiroyuki Mochizuki,
  • Hiroshi Tachimoto,
  • Koichi Yamaguchi,
  • Kei Masuda,
  • Yuichi Adachi,
  • Yusei Oshima,
  • Shigemi Yoshihara,
  • Noriko Tanaka,
  • Kunitaka Ohta,
  • Masao Morita,
  • Reiko Tokuda,
  • Yoshihiko Kitou,
  • Hayao Araki,
  • Akiko Yamaoka,
  • Akio Nakamura

DOI
https://doi.org/10.1016/j.alit.2017.04.008
Journal volume & issue
Vol. 67, no. 1
pp. 72 – 78

Abstract

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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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