NCT03664882

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Rhinitis Seasonal

Interventions

Type	Name	Description
DRUG	Fexofenadine M016455	Pharmaceutical form: tablet Route of administration: oral
DRUG	Placebo	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-01-03
• Completion: 2019-01-03
• First posted: 2018-09-11
• Last updated: 2022-04-25

Locations

1 site across 1 country: Canada