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

NCT ID: NCT00784732

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

QAV680

Intervention Type DRUG

2

Group Type EXPERIMENTAL

QAV680

Intervention Type DRUG

3

Group Type ACTIVE_COMPARATOR

Mometasone Furoate

Intervention Type DRUG

Interventions

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QAV680

Intervention Type DRUG

QAV680

Intervention Type DRUG

Mometasone Furoate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis Investigator Site

Locations

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Novartis Investigator Site

Toronto, , Canada

Site Status

Countries

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Canada

Other Identifiers

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CQAV680A2202

Identifier Type: -

Identifier Source: org_study_id

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