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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103050
• Other study ID #: CQAV680A2204
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: February 20, 2017
• Start date: March 22, 2010
• Est. completion date: July 28, 2010

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 28, 2010
• Est. primary completion date: July 28, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• QAV680 + Cetirizine Placebo

• QAV680 + Cetirizine

• Cetirizine + QAV680 Placebo

• QAV680 Placebo + Cetirizine Placebo

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Symptom Score measured during allergen exposure		14 Days
Secondary	Nasal airway patency assessed by acoustic rhinometry during allergen exposure		14 days
Secondary	Nasal secretion weight during allergen exposure		14 days
Secondary	Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure		14 days

External Links

•   Publication Link QAV680, cetirizine and their combination reduce nasal symptoms in patients with intermittent allergic rhinitis in an environmental exposure chamber
•   Results for CQAV680A2204 from the Novartis Clinical Trials Website