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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001389-14 | EudraCT Number |
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This study will assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QAW039 + Montelukast | Experimental |
| |
| QAW039 Once a day (q.d.) | Experimental |
| |
| QAW039 Twice a day (b.i.d.) | Experimental |
| |
| Montelukast | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QAW039 | Drug |
| ||
| Montelukast |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Nasal Symptom Score from baseline at 14 days | Total Nasal Symptom Score (TNSS) averaged over the last two hours (2-4h) of exposure following 14 days treatment with QAW039 and/or Montelukast or matched placebo | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Ocular Symptom score from Baseline at 14 days | Total Ocular Symptom Score (TOSS), defined as the sum of ocular symptoms of eye tearing, itching, watery eyes and redness, each of which is scored on a scale from 0 and 3 | Baseline, Day 14 |
| Change in Nasal Flow from baseline at 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hanover | 30625 | Germany |
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| Drug |
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| Placebo | Drug |
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Measured using rhinomanometry Flow rates at 150 Pa will be obtained separately for the right and left nostrils (cm^3/second). The sum of the flow rates of both nostrils will be calculated from the two measurements |
| Prior to, and every 60 min during allergen exposure period |
| Change in Nasal excretion weight from baseline at 14 days | Total weight of tissues (before and after use) | Baseline, Day 14 |
| Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days | Change in FEV1 from Baseline | Baseline, Day 14 |
| Change in Forced Vital Capacity (FVC) from baseline at 14 days | Change in FVC from Baseline | Baseline, Day 14 |
| Change in FEV1/FVC at from baseline at 14 days | Change in FEV1/FVC from Baseline | Baseline, Day 14 |
| Plasma Concentration maximum (Cmax) | Determined at steady state in plasma | Day 1-14 |
| Plasma Concentration Minimum (Cmin) | Determined at steady state in plasma | Day 1-14 |
| Plasma Concentration Average (Cav) | Determined at steady state in plasma | Day 1-14 |
| Time of Cmax (Tmax) | Determined at steady state in plasma | Day 1-14 |
| Area Under Curve (AUCtau) | Determined at steady state in plasma | Day 1-14 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000604875 | fevipiprant |
| C093875 | montelukast |
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