Back to results

A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

QAV680 + Cetirizine Placebo

QAV680 + Cetirizine

Cetirizine + QAV680 Placebo

QAV680 Placebo + Cetirizine Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic inflammation, Seasonal rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons
positive skin prick test to ragweed allergen within twelve months of screening

Exclusion criteria:

Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)
Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease
Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

QAV680 + Cetirizine Placebo

QAV680 + Cetirizine

Cetirizine + QAV680 Placebo

QAV680 Placebo + Cetirizine Placebo

Arm Description

Outcomes

Primary Outcome Measures

Total Nasal Symptom Score measured during allergen exposure

Secondary Outcome Measures

Nasal airway patency assessed by acoustic rhinometry during allergen exposure

Nasal secretion weight during allergen exposure

Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure

Full Information

NCT ID

NCT01103050

First Posted

April 12, 2010

Last Updated

February 20, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01103050

Brief Title

A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine

Official Title

A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in an Environmental Exposure Chamber

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

March 22, 2010 (Actual)

Primary Completion Date

July 28, 2010 (Actual)

Study Completion Date

July 28, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic inflammation, Seasonal rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QAV680 + Cetirizine Placebo

Arm Type

Active Comparator

Arm Title

QAV680 + Cetirizine

Arm Type

Experimental

Arm Title

Cetirizine + QAV680 Placebo

Arm Type

Active Comparator

Arm Title

QAV680 Placebo + Cetirizine Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

QAV680 + Cetirizine Placebo

Intervention Type

Drug

Intervention Name(s)

QAV680 + Cetirizine

Intervention Type

Drug

Intervention Name(s)

Cetirizine + QAV680 Placebo

Intervention Type

Drug

Intervention Name(s)

QAV680 Placebo + Cetirizine Placebo

Primary Outcome Measure Information:

Title

Total Nasal Symptom Score measured during allergen exposure

Time Frame

14 Days

Secondary Outcome Measure Information:

Title

Nasal airway patency assessed by acoustic rhinometry during allergen exposure

Time Frame

14 days

Title

Nasal secretion weight during allergen exposure

Time Frame

14 days

Title

Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons positive skin prick test to ragweed allergen within twelve months of screening Exclusion criteria: Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes) Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Ontario

Country

Canada

12. IPD Sharing Statement

Links:

URL

http://www.ers-education.org/home/browse-all-content.aspx?idParent=136559

Description

Publication Link QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamber

Learn more about this trial

A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine

We'll reach out to this number within 24 hrs