A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00784732 |
Recruitment Status :
Completed
First Posted : November 4, 2008
Last Update Posted : November 18, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Seasonal Allergic Rhinitis | Drug: QAV680 Drug: Mometasone Furoate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: QAV680 |
Experimental: 2 |
Drug: QAV680 |
Active Comparator: 3 |
Drug: Mometasone Furoate |
- 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 ]
- Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin) [ Time Frame: After 8h exposure in EEC ]
- Absolute eosinophil count from nasal lavage collected [ Time Frame: During exposure in EEC ]
- Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC [ Time Frame: During exposure in EEC ]
- Total Ocular Symptom Score measured during exposure in the EEC [ Time Frame: During exposure in EEC ]
- Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis [ Time Frame: Through out study ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784732
Canada | |
Novartis Investigator Site | |
Toronto, Canada |
Principal Investigator: | Novartis | Novartis Investigator Site |
Additional Information:
Responsible Party: | External Affairs, Novartis |
ClinicalTrials.gov Identifier: | NCT00784732 History of Changes |
Other Study ID Numbers: |
CQAV680A2202 |
First Posted: | November 4, 2008 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | November 2016 |
Keywords provided by Novartis:
Seasonal Allergic Rhinitis Environmental Exposure Chamber nasal lavage |
Additional relevant MeSH terms:
Rhinitis Rhinitis, Allergic 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 Dermatologic Agents Anti-Allergic Agents |