Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
The study duration for each patient is 3 weeks and 3 days: Lead-in period: 1 week Treatment period: 2 weeks Follow-up period: 3 days

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

Conditions
-----------------
Rhinitis Seasonal

Intervention / Treatment
-----------------
* Drug: fexofenadine HCL (M016455)
* Drug: pseudoephedrine
* Drug: fexofenadine HCL matching placebo
* Drug: pseudoephedrine matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years Exclusion criteria: At the start of the placebo lead-in period: Patients who are negative for IgE Antibody test Expected nasal congestion score is less than 2 The last 3 days of the lead-in period: Nasal congestion scores are 2 or more and not all 4 Patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). A total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6 Patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FEX 60 mg<br>Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination) | Drug: fexofenadine HCL (M016455)<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: pseudoephedrine<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: fexofenadine HCL matching placebo<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: pseudoephedrine matching placebo<br>* Pharmaceutical form:tablet Route of administration: oral<br>|
| Experimental: FEX 60 mg/PSE 60 mg<br>Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination) | Drug: fexofenadine HCL (M016455)<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: pseudoephedrine<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: fexofenadine HCL matching placebo<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: pseudoephedrine matching placebo<br>* Pharmaceutical form:tablet Route of administration: oral<br>|
| Experimental: FEX 60 mg/PSE 120 mg<br>Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg | Drug: fexofenadine HCL (M016455)<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: pseudoephedrine<br>* Pharmaceutical form:tablet Route of administration: oral<br>Drug: fexofenadine HCL matching placebo<br>* Pharmaceutical form:tablet Route of administration: oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the nasal congestion score based on the patient's symptom diary |  | over 2 treatment weeks (from baseline to end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom |  | over 2 treatment weeks (from baseline to end of treatment) | 
| Changes in total score of 4 symptoms on a daily, day-time, and night-time bases |  | over 2 treatment weeks (from baseline to end of treatment) | 
| Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score |  | over 2 treatment weeks (from baseline to end of treatment) | 
| Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis |  | over 2 treatment weeks (from baseline to end of treatment) | 
| Nasal findings |  | over 2 treatment weeks (from baseline to end of treatment) | 
| Patient's impression |  | over 2 treatment weeks (from baseline to end of treatment) | 
| Patient's safety |  | over 2 treatment weeks (from baseline to end of treatment) |