Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants — FEXPOLSAR  

Rhinitis Seasonal Clinical Trial

Official title: Phase 3, Single-center, Sequential and Parallel-group, Double-blind, Randomized Study Evaluating the Efficacy and Safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo in Subjects Suffering From Seasonal Allergic Rhinitis With Symptoms Aggravated in Presence of Pollutants

Status Completed

Clinical Trial Summary

Primary Objectives:

• To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit.

• To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates.

Secondary Objective:

To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.

Clinical Trial Description

The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit. ;

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis Seasonal
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

• NCT number: NCT03664882
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: September 17, 2018
• Completion date: January 3, 2019