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

Novartis

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: QAV680 + Cetirizine Placebo; Drug: QAV680 + Cetirizine; Drug: Cetirizine + QAV680 Placebo; Drug: QAV680 Placebo + Cetirizine Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103050

CQAV680A2204

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

QAV680 + Cetirizine Placebo

Active Comparator group

Treatment:

Drug: QAV680 + Cetirizine Placebo

QAV680 + Cetirizine

Experimental group

Treatment:

Drug: QAV680 + Cetirizine

Cetirizine + QAV680 Placebo

Active Comparator group

Treatment:

Drug: Cetirizine + QAV680 Placebo

QAV680 Placebo + Cetirizine Placebo

Placebo Comparator group

Treatment:

Drug: QAV680 Placebo + Cetirizine Placebo