Back to resultsA Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
QAV680
QAV680
Mometasone Furoate
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Seasonal Allergic Rhinitis, Environmental Exposure Chamber, nasal lavage
Eligibility 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
Sites / Locations
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
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
Secondary Outcome Measures
Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)
Absolute eosinophil count from nasal lavage collected
Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC
Total Ocular Symptom Score measured during exposure in the EEC
Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00784732
Brief Title
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Seasonal Allergic Rhinitis, Environmental Exposure Chamber, nasal lavage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
QAV680
Intervention Type
Drug
Intervention Name(s)
QAV680
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin)
Time Frame
After 8h exposure in EEC
Title
Absolute eosinophil count from nasal lavage collected
Time Frame
During exposure in EEC
Title
Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC
Time Frame
During exposure in EEC
Title
Total Ocular Symptom Score measured during exposure in the EEC
Time Frame
During exposure in EEC
Title
Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis
Time Frame
Through out study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Investigator Site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Toronto
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
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