Intermittent and episode-driven use of pranlukast to reduce the frequency of wheezing in atopic children: a randomized, double-blind, placebo-controlled trial

World Allergy Organization Journal

Mitsuyoshi Urashima⁵  Sankei Nishima⁴  Akihiro Morikawa⁷  Chizuko Sugizaki¹  Naomi Kondo⁶  Fumitake Kurosaka⁸  Kazuki Sato³  Akihiko Terada²  Motohiro Ebisawa¹ 

[1] Department of Allergy, Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan;Department of Pediatrics, Daido Hospital, Nagoya, Japan;Department of Pediatrics, National Shimoshizu Hospital, Yotsukaido, Japan;Allergy division, Fukuoka National Hospital, Fukuoka, Japan;Division of Molecular Epidemiology, Jikei University School of Medicine, Nishi-shimbashi 3-25-8, Minato-ku 105-8461, Tokyo, Japan;Gifu University Graduate School of Medicine, Gifu, Japan;Gunma University & Kitakanto Allergy Institute, Maebashi, Japan;Kurosaka Pediatrics and Allergy Clinic, Himji, Japan

关键词: Children;    Japan;    Asthma exacerbations;    Leukotriene receptor antagonist;    Pranlukast;   

Others  :  1180924
DOI  :  10.1186/s40413-015-0062-3

 received in 2014-12-20, accepted in 2015-02-06,  发布年份 2015

【 摘 要 】

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.

Trial registration

UMIN000000634 webcite

【 授权许可】

   
2015 Ebisawa et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

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