Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants

Study Overview
=================
Brief Summary
-----------------
Primary Objectives: To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit. To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates. Secondary Objective: To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.

Detailed Description
-----------------
The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.

Official Title
-----------------
Phase 3, Single-center, Sequential and Parallel-group, Double-blind, Randomized Study Evaluating the Efficacy and Safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo in Subjects Suffering From Seasonal Allergic Rhinitis With Symptoms Aggravated in Presence of Pollutants

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

Intervention / Treatment
-----------------
* Drug: Fexofenadine M016455
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Males or females between the ages of 18 and 65 suffering from seasonal allergic rhinitis provoked by ragweed pollen. Having a 2-year history of seasonal allergic rhinitis with positive skin prick test to ragweed allergen at screening with a wheal diameter at least 3 mm larger than that produced by the negative control. Subjects with antecedents of allergic seasonal allergic rhinitis symptom aggravation when exposed to pollen and air pollutants (i.e., cleaning products, diesel, paints). Subjects having a total nasal symptom score ≥3 in Period 1 (Visit 2). Exclusion criteria: History of anaphylaxis to ragweed pollen. History of asthma. Mild asthmatics treated only with pro re nata short-acting beta2-agonists, 2 doses or less per week can be enrolled. History of chronic sinusitis. History of systemic disease affecting the immune system. Evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge. Any history of Grade 4 anaphylaxis due to any cause as defined by the Common Terminology Criteria for Adverse Event grading criteria (Life threatening consequences: urgent intervention indicated). Presence or history of drug hypersensitivity to fexofenadine. Subjects receiving build-up injections of pollen allergen immunotherapy (those on stable maintenance dosing can be included). Subjects taking any forbidden treatments/nutriments. 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: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Fexofenadine<br>Fexofenadine, single administration | Drug: Fexofenadine M016455<br>* Pharmaceutical form: tablet Route of administration: oral<br>|
| Placebo Comparator: Placebo<br>Placebo, single administration | Drug: Placebo<br>* Pharmaceutical form: tablet Route of administration: oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptom score (TNSS) | Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2 | From hour 0 to hour 12 in Period 1 and Period 2 | 
| TNSS | Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3 | From hour 2 to hour 12 in Period 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total symptom score (TSS) | Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 | From hour 2 to hour 12 in Period 3 | 
| Individual symptom score | Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12 | From hour 2 to hour 12 in Period 3 | 
| TNSS | Assessed by change in TNSS by time point from hour 2 to hour 12 | From hour 2 to hour 12 in Period 3 | 
| Adverse events | Incidence of adverse events | Up to 4.5 months |