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

November 16, 2016 updated by: Novartis

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

This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Novartis Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: QAV680
Experimental: 2
Drug: QAV680
Active Comparator: 3
Drug: Mometasone Furoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
TNSS: 6-8h during EEC exposure on Day 10

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 4, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAV680A2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe