Double blind randomized crossover trial of PF-03654764+fexofenadine in the environmental exposure unit (EEU)

نویسندگان

  • Michelle L North
  • Terry Walker
  • Lisa M Steacy
  • Barnaby G Hobsbawn
  • Richard J Allan
  • Frances Hackman
  • Xiaoqun Sun
  • Andrew G Day
  • Anne K Ellis
چکیده

Background Oral histamine receptor–1 antagonists, such as fexofenadine, offer suboptimal relief of allergic rhinitis-associated nasal congestion. Combinations with oral sympathomimetics, such as pseudoephedrine, relieve congestion but produce side effects. Histamine receptor-3 antagonists, such as PF-03654764, reduce congestion in animals and have been proposed as novel therapeutics. Previous nasal allergen challenge studies of similar H1+H3 receptor antagonist combinations demonstrated reduced congestion. Herein we employ the Environmental Exposure Unit (EEU) to conduct the first randomized controlled trial of PF-03654764 in allergic rhinitis. The primary objective was to compare the effect of PF-03654764+fexofenadine to pseudoephedrine+fexofenadine on the subjective measures of congestion and Total Nasal Symptom Score (TNSS). The objective of post-hoc analyses were to compare all treatments to placebo and determine the onset of action (OA).

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عنوان ژورنال:

دوره 10  شماره 

صفحات  -

تاریخ انتشار 2014