Clinical trial NCT01804400: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-03-05
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total Nasal Symptom Score from baseline at 14 days
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Change in Total Ocular Symptom score from Baseline at 14 days
timeFrame: Baseline, Day 14
measure: Change in Nasal Flow from baseline at 14 days
timeFrame: Prior to, and every 60 min during allergen exposure period
measure: Change in Nasal excretion weight from baseline at 14 days
timeFrame: Baseline, Day 14
measure: Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days
timeFrame: Baseline, Day 14
measure: Change in Forced Vital Capacity (FVC) from baseline at 14 days
timeFrame: Baseline, Day 14
measure: Change in FEV1/FVC at from baseline at 14 days
timeFrame: Baseline, Day 14
measure: Plasma Concentration maximum (Cmax)
timeFrame: Day 1-14
measure: Plasma Concentration Minimum (Cmin)
timeFrame: Day 1-14
measure: Plasma Concentration Average (Cav)
timeFrame: Day 1-14
measure: Time of Cmax (Tmax)
timeFrame: Day 1-14
measure: Area Under Curve (AUCtau)
timeFrame: Day 1-14
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: