NCT01804400
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Change in Total Nasal Symptom Score from baseline at 14 days
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
QAW039 + Montelukast
Experimental
Intervention: Montelukast (Drug)
QAW039 + Montelukast
Experimental
Intervention: QAW039 (Drug)
QAW039 + Montelukast
Experimental
Intervention: Placebo (Drug)
QAW039 Once a day (q.d.)
Experimental
Intervention: QAW039 (Drug)
QAW039 Once a day (q.d.)
Experimental
Intervention: Placebo (Drug)
QAW039 Twice a day (b.i.d.)
Experimental
Intervention: QAW039 (Drug)
QAW039 Twice a day (b.i.d.)
Experimental
Intervention: Placebo (Drug)
Montelukast
Active Comparator
Intervention: Montelukast (Drug)
Montelukast
Active Comparator
Intervention: Placebo (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Total Nasal Symptom Score from baseline at 14 days
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
Secondary Outcomes
- Change in Nasal Flow from baseline at 14 days(Prior to, and every 60 min during allergen exposure period)
- Change in Total Ocular Symptom score from Baseline at 14 days(Baseline, Day 14)
- Change in Nasal excretion weight from baseline at 14 days(Baseline, Day 14)
- Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days(Baseline, Day 14)
- Change in FEV1/FVC at from baseline at 14 days(Baseline, Day 14)
- Plasma Concentration maximum (Cmax)(Day 1-14)
- Plasma Concentration Minimum (Cmin)(Day 1-14)
- Change in Forced Vital Capacity (FVC) from baseline at 14 days(Baseline, Day 14)
- Plasma Concentration Average (Cav)(Day 1-14)
- Time of Cmax (Tmax)(Day 1-14)
- Area Under Curve (AUCtau)(Day 1-14)
Investigators
Study Sites (1)
Loading locations...
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