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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAV680 + Cetirizine Placebo | Active Comparator |
| |
| QAV680 + Cetirizine | Experimental |
| |
| Cetirizine + QAV680 Placebo | Active Comparator |
| |
| QAV680 Placebo + Cetirizine Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAV680 + Cetirizine Placebo | Drug |
| ||
| QAV680 + Cetirizine |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score measured during allergen exposure | 14 Days |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ontario | Canada |
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| Label | URL |
|---|---|
| Publication Link QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamber | View source |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Cetirizine + QAV680 Placebo | Drug |
|
| QAV680 Placebo + Cetirizine Placebo | Drug |
|
| 14 days |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |