title: Intermittent and episode-driven use of pranlukast to reduce the frequency of wheezing in atopic children: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Leukotriene receptor antagonist (LTRA) therapy reduces asthma exacerbations in children older than 2 years. However, whether early intervention using LTRA in atopic smaller children aged 1 to 2 years who had experienced episodic wheezing can reduce the frequency of wheezing is unknown.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled, multi-center trial of episode-driven intermittent use of pranlukast for 12 months, one of the LTRAs, was conducted by enrolling children who had two, but not more than two, episodes of wheezing prior to entry and were allergen-specific IgE-positive (≥class 2). The primary outcome was increased episodes of wheezing more than once a month for 3 months.
  
  
  RESULTS
  Seventy-seven children were randomly assigned to receive pranlukast (n = 37) or placebo (n = 40). The primary outcome occurred in 10 of 36 (28%) of the pranlukast group and 14 of 39 (36%) in the placebo group, which was not significantly different (P = 0.45). Even though the study period was extended to a maximum of >5 years, there was no significant difference in the Kaplan-Meier curves in the occurrence of the primary outcome between the two groups.
  
  
  CONCLUSIONS
  These results suggest that intermittent and episode-driven use of pranlukast in small children with a prior history of wheezing and atopic sensitization may not reduce the frequency of wheezing later in life. However, the sample size was too small to make a definitive conclusion.
  
  
  BACKGROUND
  UMIN000000634.
authors: Department of Allergy, Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan.
authors: Motohiro
authors: M
authors: Ebisawa
authors: Department of Pediatrics, Daido Hospital, Nagoya, Japan.
authors: Akihiko
authors: A
authors: Terada
authors: Department of Pediatrics, National Shimoshizu Hospital, Yotsukaido, Japan.
authors: Kazuki
authors: K
authors: Sato
authors: Kurosaka Pediatrics and Allergy Clinic, Himji, Japan.
authors: Fumitake
authors: F
authors: Kurosaka
authors: Gifu University Graduate School of Medicine, Gifu, Japan.
authors: Naomi
authors: N
authors: Kondo
authors: Department of Allergy, Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan.
authors: Chizuko
authors: C
authors: Sugizaki
authors: Gunma University & Kitakanto Allergy Institute, Maebashi, Japan.
authors: Akihiro
authors: A
authors: Morikawa
authors: Allergy division, Fukuoka National Hospital, Fukuoka, Japan.
authors: Sankei
authors: S
authors: Nishima
authors: Division of Molecular Epidemiology, Jikei University School of Medicine, Nishi-shimbashi 3-25-8, Minato-ku, Tokyo 105-8461 Japan.
authors: Mitsuyoshi
authors: M
authors: Urashima
keywords: Asthma exacerbations; Children; Japan; Leukotriene receptor antagonist; Pranlukast