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

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 registrationUMIN000000634

Source: http://www.waojournal.org/content/8/1/11

medical rehab sport