Novartis Investigative Site
Hanover, 30625, Germany
NCT Number: NCT01804400
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Hanover, 30625, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 14
Total weight of tissues (before and after use)
Time frame: Baseline, Day 14
Change in FEV1 from Baseline
Time frame: Baseline, Day 14
Change in FVC from Baseline
Time frame: Baseline, Day 14
Change in FEV1/FVC from Baseline
Time frame: Day 1-14
Determined at steady state in plasma
Time frame: Day 1-14
Determined at steady state in plasma
Time frame: Day 1-14
Determined at steady state in plasma
Time frame: Day 1-14
Determined at steady state in plasma
Time frame: Day 1-14
Determined at steady state in plasma
Novartis Pharmaceuticals
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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