A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber

Study Overview
=================
Brief Summary
-----------------
This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.

Official Title
-----------------
A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model

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

Intervention / Treatment
-----------------
* Drug: QAV680
* Drug: QAV680
* Drug: Mometasone Furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive skin prick test to ragweed allergen FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2. Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. Non-smokers and ex-smokers (≤10 pack years and >6 months of smoking abstinence). Understand and sign the written informed consent Exclusion Criteria: Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing. Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. Significant illness within two (2) weeks prior to initial dosing. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Other protocol-defined inclusion/exclusion criteria may apply

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: 1<br> | Drug: QAV680<br> <br> |
| Experimental: 2<br> | Drug: QAV680<br> <br> |
| Active Comparator: 3<br> | Drug: Mometasone Furoate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC |  | TNSS: 6-8h during EEC exposure on Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin) |  | After 8h exposure in EEC | 
| Absolute eosinophil count from nasal lavage collected |  | During exposure in EEC | 
| Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC |  | During exposure in EEC | 
| Total Ocular Symptom Score measured during exposure in the EEC |  | During exposure in EEC | 
| Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis |  | Through out study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasonal Allergic Rhinitis, Environmental Exposure Chamber, nasal lavage