A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure Chamber

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Three-period Incomplete Cross Over Study to Compare the Efficacy of QAW039 Alone and in Combination With Montelukast in Patients With Allergic Rhinitis Using an Environmental Exposure Chamber

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: QAW039
* Drug: Montelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two grass pollen allergy seasons. A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick test within 12 months prior to Visit 1 is also acceptable. FEV1 measured by spirometry must be ≥80% of their predicted value at screening. If the patient does not achieve ≥80% of their predicted value this may be repeated prior to the EEC challenge at visit 2. TNSS score ≥6 on at least one assessment during the 2h EEC challenge at Screening. Exclusion Criteria: Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. Pregnant or nursing (lactating) women, Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QAW039 + Montelukast<br> | Drug: QAW039<br> <br> Drug: Montelukast<br> <br> Drug: Placebo<br> <br> |
| Experimental: QAW039 Once a day (q.d.)<br> | Drug: QAW039<br> <br> Drug: Placebo<br> <br> |
| Experimental: QAW039 Twice a day (b.i.d.)<br> | Drug: QAW039<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Montelukast<br> | Drug: Montelukast<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |