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

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.

Timeline

Start

2023-01-23

Primary completion

2023-03-14

Completion

2023-03-14

Outcome

Met primary endpoint

registry analysis (superiority test); Arm A (Active-active) vs Arm B (Placebo-active); p = 0.038; Least Square Mean Difference -4.24 (95% CI -8.24 to -0.23); ANCOVA NCT05692154 ↗

Drugs

Indications