A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine

Study Overview
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Brief Summary
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This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.

Official Title
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A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: QAV680 + Cetirizine Placebo
* Drug: QAV680 + Cetirizine
* Drug: Cetirizine + QAV680 Placebo
* Drug: QAV680 Placebo + Cetirizine Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons positive skin prick test to ragweed allergen within twelve months of screening Exclusion criteria: Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes) Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QAV680 + Cetirizine Placebo<br> | Drug: QAV680 + Cetirizine Placebo<br> <br> |
| Experimental: QAV680 + Cetirizine<br> | Drug: QAV680 + Cetirizine<br> <br> |
| Active Comparator: Cetirizine + QAV680 Placebo<br> | Drug: Cetirizine + QAV680 Placebo<br> <br> |
| Placebo Comparator: QAV680 Placebo + Cetirizine Placebo<br> | Drug: QAV680 Placebo + Cetirizine Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score measured during allergen exposure |  | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal airway patency assessed by acoustic rhinometry during allergen exposure |  | 14 days | 
| Nasal secretion weight during allergen exposure |  | 14 days | 
| Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic inflammation, Seasonal rhinitis