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

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-22

Study Completion Date

2010-07-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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QAV680 + Cetirizine Placebo

Group Type ACTIVE_COMPARATOR

QAV680 + Cetirizine Placebo

Intervention Type DRUG

QAV680 + Cetirizine

Group Type EXPERIMENTAL

QAV680 + Cetirizine

Intervention Type DRUG

Cetirizine + QAV680 Placebo

Group Type ACTIVE_COMPARATOR

Cetirizine + QAV680 Placebo

Intervention Type DRUG

QAV680 Placebo + Cetirizine Placebo

Group Type PLACEBO_COMPARATOR

QAV680 Placebo + Cetirizine Placebo

Intervention Type DRUG

Interventions

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QAV680 + Cetirizine Placebo

Intervention Type DRUG

QAV680 + Cetirizine

Intervention Type DRUG

Cetirizine + QAV680 Placebo

Intervention Type DRUG

QAV680 Placebo + Cetirizine Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No