Rhinitis Seasonal Clinical Trial
Official title:
A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg in Patients With Seasonal Allergic Rhinitis
Primary Objective:
- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg -
pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg -
pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60)
in patients with seasonal allergic rhinitis (SAR).
Secondary Objectives:
- To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on
nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily
activity impairment.
- To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.
The study duration for each patient is 3 weeks and 3 days:
1. Lead-in period: 1 week
2. Treatment period: 2 weeks
3. Follow-up period: 3 days
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03664882 -
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
|
Phase 3 |