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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
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE November 3, 2008
First Posted Date  ICMJE November 4, 2008
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00784732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Allergic Rhinitis
Intervention  ICMJE
  • Drug: QAV680
  • Drug: Mometasone Furoate
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: QAV680
  • Experimental: 2
    Intervention: Drug: QAV680
  • Active Comparator: 3
    Intervention: Drug: Mometasone Furoate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2010)
44
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2008)
45
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00784732
Other Study ID Numbers  ICMJE CQAV680A2202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Novartis Novartis Investigator Site
PRS Account Novartis
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP