A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00784732
First received: November 3, 2008
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: QAV680
Drug: Mometasone Furoate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Model

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Total Nasal Symptom Score (TNSS) over the last 2 hours of exposure in the EEC Percentage nasal lavage eosinophil count post EEC [ Time Frame: TNSS: 6-8h during EEC exposure on Day 10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin) [ Time Frame: After 8h exposure in EEC ] [ Designated as safety issue: Yes ]
  • Absolute eosinophil count from nasal lavage collected [ Time Frame: During exposure in EEC ] [ Designated as safety issue: Yes ]
  • Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC [ Time Frame: During exposure in EEC ] [ Designated as safety issue: No ]
  • Total Ocular Symptom Score measured during exposure in the EEC [ Time Frame: During exposure in EEC ] [ Designated as safety issue: No ]
  • Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis [ Time Frame: Through out study ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: QAV680
Experimental: 2 Drug: QAV680
Active Comparator: 3 Drug: Mometasone Furoate

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive skin prick test to ragweed allergen
  • FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2.
  • Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
  • Non-smokers and ex-smokers (≤10 pack years and >6 months of smoking abstinence).
  • Understand and sign the written informed consent

Exclusion Criteria:

  • Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
  • Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
  • Significant illness within two (2) weeks prior to initial dosing.
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria may apply

  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: NCT00784732

Locations
Canada
Novartis Investigator Site
Toronto, Canada
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis Investigator Site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00784732     History of Changes
Other Study ID Numbers: CQAV680A2202
Study First Received: November 3, 2008
Last Updated: September 1, 2010
Health Authority: Canada: Health Canada

Keywords provided by Novartis:
Seasonal Allergic Rhinitis
Environmental Exposure Chamber
nasal lavage

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2014