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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01804400
First received: October 4, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Allergic Rhinitis
Drug: QAW039
Drug: Montelukast
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Total Nasal Symptom Score from baseline at 14 days [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Prior to, and every 60 min during allergen exposure period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Total weight of tissues (before and after use)

  • Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Change in FEV1 from Baseline

  • Change in Forced Vital Capacity (FVC) from baseline at 14 days [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Change in FVC from Baseline

  • Change in FEV1/FVC at from baseline at 14 days [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Change in FEV1/FVC from Baseline

  • Plasma Concentration maximum (Cmax) [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]
    Determined at steady state in plasma

  • Plasma Concentration Minimum (Cmin) [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]
    Determined at steady state in plasma

  • Plasma Concentration Average (Cav) [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]
    Determined at steady state in plasma

  • Time of Cmax (Tmax) [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]
    Determined at steady state in plasma

  • Area Under Curve (AUCtau) [ Time Frame: Day 1-14 ] [ Designated as safety issue: No ]
    Determined at steady state in plasma


Enrollment: 188
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804400

Locations
Germany
Novartis Investigative Site
Hannover, Germany, 30625
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01804400     History of Changes
Other Study ID Numbers: CQAW039A2212, 2012-001389-14
Study First Received: October 4, 2012
Last Updated: January 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014