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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
Novartis Investigative Site
Hanover, Germany
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
Time frame: Baseline, Day 14
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
Time frame: 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
Time frame: 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)
Time frame: Baseline, Day 14
Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days
Change in FEV1 from Baseline
Time frame: Baseline, Day 14
Change in Forced Vital Capacity (FVC) from baseline at 14 days
Change in FVC from Baseline
Time frame: Baseline, Day 14
Change in FEV1/FVC at from baseline at 14 days
Change in FEV1/FVC from Baseline
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Time frame: Baseline, Day 14
Plasma Concentration maximum (Cmax)
Determined at steady state in plasma
Time frame: Day 1-14
Plasma Concentration Minimum (Cmin)
Determined at steady state in plasma
Time frame: Day 1-14
Plasma Concentration Average (Cav)
Determined at steady state in plasma
Time frame: Day 1-14
Time of Cmax (Tmax)
Determined at steady state in plasma
Time frame: Day 1-14
Area Under Curve (AUCtau)
Determined at steady state in plasma
Time frame: Day 1-14