NCT05692154

A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis

A Phase IIIb, Single-center, Double-blind, Two-arms, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of 2-day Pre-treatment With Fexofenadine in Patients Suffering From Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Opella Healthcare Group SAS, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a proof-of-concept study to demonstrate if a daily dose of a 2-days pre-treatment of Fexofenadine 180mg is effective in alleviating the AR symptoms and to assess the additional benefit to the patient in terms of preventing Allergic Rhinitis (AR) symptoms. The total study duration per participant is expected at least 4 months, depending on the timing of the screening visit. 5 visits are planned, screening, confirmation inclusion challenge, randomization visit, challenge and end of study visit.

Detailed description

The end of the study is defined as the date of the last visit of the last participant in the study. A participant is considered to have completed the study if he/she has completed all visits of the study including Visit 5 (Day 5).

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fexofenadine	Fexofenadine oral tablet
DRUG	Placebo	Fexofenadine matching placebo oral tablet

Timeline

• Start date: 2023-01-23
• Primary completion: 2023-03-14
• Completion: 2023-03-14
• First posted: 2023-01-20
• Last updated: 2025-09-09
• Results posted: 2024-05-16

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study