کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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5665236 | 1407738 | 2017 | 9 صفحه PDF | دانلود رایگان |
BackgroundEnvironmental exposure chambers have been used to expose subjects to aeroallergens to investigate the efficacy of prophylactic treatment with symptomatic agents in Japan. We first examined the therapeutic effect of bilastine (BIL), a novel non-sedative second-generation H1-antihistamine, in subjects with Japanese cedar pollinosis using an artificial exposure chamber (OHIO Chamber).MethodsThis was a randomized, double-blind, four-way crossover, placebo- and active-controlled phase II study (trial registration number JapicCTI-132213). Subjects were exposed to cedar pollen (8000Â grains/m3) for 2Â h on Day â1 and 4Â h each on Day 1 and 2. BIL 10 or 20Â mg, placebo, or fexofenadine hydrochloride (FEX) 60Â mg was administered orally 1Â h after the start of pollen exposure on Day 1. Placebo or FEX was administered 12Â h after the first dosing. The primary efficacy endpoint was the sum of total nasal symptom score (TNSS) from 0 to 3Â h after the Day 1 dosing.ResultsWe enrolled 136 subjects and the sum of TNSS on Day 1 of the three active treatments was significantly lower than that of placebo and was maintained up to 26Â h after the first dosing (Day 2). The sum of TNSS or sneezing score on Day 1 after BIL 20Â mg was more significantly decreased than after FEX. Moreover, BIL showed a faster onset of action than FEX.ConclusionsWe demonstrated the efficacy, rapid onset, and long duration of action of BIL in subjects with Japanese cedar pollinosis exposed to cedar pollen using the OHIO Chamber.
Journal: Allergology International - Volume 66, Issue 1, January 2017, Pages 123-131