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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2010
CompletedFirst Submitted
Initial submission to the registry
April 12, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2010
CompletedFebruary 23, 2017
February 1, 2017
4 months
April 12, 2010
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Nasal Symptom Score measured during allergen exposure
14 Days
Secondary Outcomes (3)
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
Study Arms (4)
QAV680 + Cetirizine Placebo
ACTIVE COMPARATORQAV680 + Cetirizine
EXPERIMENTALCetirizine + QAV680 Placebo
ACTIVE COMPARATORQAV680 Placebo + Cetirizine Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Ontario, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2010
First Posted
April 13, 2010
Study Start
March 22, 2010
Primary Completion
July 28, 2010
Study Completion
July 28, 2010
Last Updated
February 23, 2017
Record last verified: 2017-02