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

Controlled Allergen Challenge Facilities and Their Unique Contributions to Allergic Rhinitis Research

“…Although the combination of H 3 antagonist/fexofenadine significantly reduced TNSS, relative to placebo, with an onset of action of 60 min, the treatment was not superior to pseudoephedrine/ fexofenadine [80]. Additionally, an elevated incidence of adverse events was noted, potentially related to the role of H 3 receptors in the central-nervous system [80,83,84]. Further development of H 3 receptor antagonists with lesser penetrance into the central nervous system may exhibit a more favorable safety profile, or even increased efficacy against allergic rhinitis symptoms [80].…”

“…However, the H 3 receptor antagonist showed superior efficacy compared to pseudoephedrine when the baseline-adjusted area under the curve of participant-scored congestion was used [82]. Recently, a placebo-controlled crossover study of a specific H 3 receptor antagonist with or without fexofenadine was conducted in the EEU and compared to pseudoephedrine/ fexofenadine as an active control [80]. Although the combination of H 3 antagonist/fexofenadine significantly reduced TNSS, relative to placebo, with an onset of action of 60 min, the treatment was not superior to pseudoephedrine/ fexofenadine [80].…”

“…Additionally, an elevated incidence of adverse events was noted, potentially related to the role of H 3 receptors in the central-nervous system [80,83,84]. Further development of H 3 receptor antagonists with lesser penetrance into the central nervous system may exhibit a more favorable safety profile, or even increased efficacy against allergic rhinitis symptoms [80].…”

“…Recently, a placebo-controlled crossover study of a specific H 3 receptor antagonist with or without fexofenadine was conducted in the EEU and compared to pseudoephedrine/ fexofenadine as an active control [80]. Although the combination of H 3 antagonist/fexofenadine significantly reduced TNSS, relative to placebo, with an onset of action of 60 min, the treatment was not superior to pseudoephedrine/ fexofenadine [80]. Additionally, an elevated incidence of adverse events was noted, potentially related to the role of H 3 receptors in the central-nervous system [80,83,84].…”

“…Combinations of antihistamines with sympathomimetic agents have been proven effective against congestion; however, due to side effects such as insomnia and hypertension, they are contraindicated in those with cardiovascular problems [73,74,79,80]. H 3 receptor antagonists as decongestants were suggested as potentially safer alternatives.…”