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

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ClinicalTrials.gov Identifier: NCT00784732
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : November 18, 2016
Sponsor:
Information provided by:
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: QAV680 Drug: Mometasone Furoate Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: QAV680
Experimental: 2 Drug: QAV680
Active Comparator: 3 Drug: Mometasone Furoate


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Measure of nasal cytokines (ECP, IL-5, IL-13, PGD2, Eotaxin) [ Time Frame: After 8h exposure in EEC ]
  2. Absolute eosinophil count from nasal lavage collected [ Time Frame: During exposure in EEC ]
  3. Nasal airway patency assessed by acoustic rhinometry during exposure in the EEC [ Time Frame: During exposure in EEC ]
  4. Total Ocular Symptom Score measured during exposure in the EEC [ Time Frame: During exposure in EEC ]
  5. Assess pharmacokinetics of plasma QAV680 in patients with seasonal allergic rhinitis [ Time Frame: Through out study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Canada
Novartis Investigator Site
Toronto, Canada
Sponsors and Collaborators
Novartis
Investigators
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Principal Investigator: Novartis Novartis Investigator Site
More Information
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Additional Information:
Results for CQAV680A2202 from the Novartis Clinical Trials Website  This link exits the ClinicalTrials.gov site

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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:
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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