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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01804400

Collaborator

(none)

188

Enrollment

Location

Arms

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: QAW039 Drug: Montelukast Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QAW039 + Montelukast	Drug: QAW039 Drug: Montelukast Drug: Placebo
Experimental: QAW039 Once a day (q.d.)	Drug: QAW039 Drug: Placebo
Experimental: QAW039 Twice a day (b.i.d.)	Drug: QAW039 Drug: Placebo
Active Comparator: Montelukast	Drug: Montelukast Drug: Placebo
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
Plasma Concentration maximum (Cmax) [Day 1-14]
Determined at steady state in plasma
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Hannover		Germany	30625

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01804400

Other Study ID Numbers:

CQAW039A2212
2012-001389-14

First Posted:

Mar 5, 2013

Last Update Posted:

Nov 18, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Rhinitis

Rhinitis, Allergic

Montelukast

Study Results

No Results Posted as of Nov 18, 2016