Effect of fexofenadine/pseudoephedrine combination tablet on nasal obstruction in patients with allergic rhinitis using rhinomanometry: A randomized controlled trial

Yosuke Nakamura,¹ Yuko Yokoyama,¹ Satoshi Koyama,¹ Kazunori Fujiwara,¹ Motoki Nakamori,¹ Taihei Fujii,² Tadao Enomoto,³ Hiromi Takeuchi¹

¹ Division of Otolaryngology, Head and Neck Surgery, Faculty of Medicine Tottori University,
² Division of Head, Neck, and Thyroid Surgery Center and Otorhinolaryngology, Kusatsu General Hospital
³ NPO Japan Health Promotion Supporting Network

Abstract

Background: A fexofenadine/pseudoephedrine combination tablet (F/P) is an optimal product for nasal obstruction. It contains fexofenadine hydrochloride, a histamine H₁-receptor antagonist for sneezing and rhinorrhea and pseudoephedrine hydrochloride, an α-adrenergic agonist. The effect of an antihistamine-decongestant on nasal obstruction has been demonstrated in previous studies, but onset of action and efficacy data on nasal obstruction are limited.
Objective: We estimated the efficacy of F/P on nasal obstruction in patients with house dust mite-induced allergic rhinitis (AR) versus fexofenadine (F) using objective methods.
Methods: In this single-center, single-dose, prospective, randomized, parallel-group study, 24 adult patients with a history of at least 2 years of AR and nasal obstruction were randomized to receive F/P or F. The effect on nasal obstruction was evaluated using nasal airflow and visual analog scale (VAS) score measured at 30-minute intervals before and for 8 hours after dosing. The primary end point was onset of action, based on a comparison of absolute change from baseline in nasal airflow between F/P and F. The protocol was registered in a clinical trial registry as UMIN 000041845.
Results: The onset of action for F/P was 30 minutes based on nasal airflow and 60 minutes based on VAS. F/P maintained a significant beneficial effect after onset of effect, while F showed no significant change during the test period.
Conclusions: We found F/P had a clear effect on nasal obstruction associated with perennial AR when compared with F. There was a time lag in nasal airflow improvement and nasal obstruction relief.
Key words: Allergic rhinitis, Antihistamine, Nasal obstruction, Rhinomanometry, Visual analog scale