NCT05720455

Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above

A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).

Detailed description

The individual study duration for each participant would be approximately 16 days.

Conditions

• Rhinitis Allergic

Interventions

Type	Name	Description
DRUG	Fexofenadine HCL and pseudoephedrine HCL	Extended-Release Tablets

Timeline

• Start date: 2025-06-15
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2023-02-09
• Last updated: 2026-02-17

Locations

11 sites across 1 country: India