Allergic Rhinitis
Conditions
Brief summary
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.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Nasal Symptom Score from baseline at 14 days | Baseline, Day 14 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nasal Flow from baseline at 14 days | Prior to, and every 60 min during allergen exposure period | 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 |
| Change in Nasal excretion weight from baseline at 14 days | Baseline, Day 14 | Total weight of tissues (before and after use) |
| Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days | Baseline, Day 14 | Change in FEV1 from Baseline |
| Change in Forced Vital Capacity (FVC) from baseline at 14 days | Baseline, Day 14 | Change in FVC from Baseline |
| Change in FEV1/FVC at from baseline at 14 days | Baseline, Day 14 | Change in FEV1/FVC from Baseline |
| Change in Total Ocular Symptom score from Baseline at 14 days | Baseline, Day 14 | 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 |
| Plasma Concentration Minimum (Cmin) | Day 1-14 | Determined at steady state in plasma |
| Plasma Concentration Average (Cav) | Day 1-14 | Determined at steady state in plasma |
| Time of Cmax (Tmax) | Day 1-14 | Determined at steady state in plasma |
| Area Under Curve (AUCtau) | Day 1-14 | Determined at steady state in plasma |
| Plasma Concentration maximum (Cmax) | Day 1-14 | Determined at steady state in plasma |
Countries
Germany
Outcome results
None listed