Status:
COMPLETED
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Lead Sponsor:
Novartis
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00784732
Start Date
September 1 2008
End Date
December 1 2008
Last Update
November 18 2016
Active Locations (1)
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1
Novartis Investigator Site
Toronto, Canada