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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103050

Enrollment

Registered

2010-04-13

Start date

2010-03-22

Completion date

2010-07-28

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic inflammation, Seasonal rhinitis

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.

Interventions

DRUGQAV680 + Cetirizine Placebo

DRUGQAV680 + Cetirizine

DRUGCetirizine + QAV680 Placebo

DRUGQAV680 Placebo + Cetirizine Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
Total Nasal Symptom Score measured during allergen exposure	14 Days

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026