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

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: QAV680 + Cetirizine Placebo; Drug: QAV680 + Cetirizine; Drug: Cetirizine + QAV680 Placebo; Drug: QAV680 Placebo + Cetirizine Placebo

• Registration Number: NCT01103050
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-22
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Primary Completion: 2010-07-28
• Study Completion: 2010-07-28
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
QAV680 + Cetirizine Placebo	QAV680 + Cetirizine Placebo	-
QAV680 + Cetirizine	QAV680 + Cetirizine	-
Cetirizine + QAV680 Placebo	Cetirizine + QAV680 Placebo	-
QAV680 Placebo + Cetirizine Placebo	QAV680 Placebo + Cetirizine Placebo	-

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score measured during allergen exposure	14 Days

Secondary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure	14 days
Nasal airway patency assessed by acoustic rhinometry during allergen exposure	14 days
Nasal secretion weight during allergen exposure	14 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇦 Ontario, Canada