Status:
UNKNOWN
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Novartis
Conditions:
Allergy
Eligibility:
All Genders
19-50 years
Phase:
PHASE4
Brief Summary
If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.
Detailed Description
Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and hist...
Eligibility Criteria
Inclusion
- Ages 19 to 50
- At least 2 year history of ragweed allergic rhinitis
- Positive skin prick tests to ragweed \>5 mm wheal diameter
- IgE \<700 iU/m
Exclusion
- Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.
- History of immunotherapy in the past 2 years
- Exposure to Omalizumab in the past 2 years
- Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
- Asthma other than mild intermittent
- Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
- Known sensitivity to study drug Xolair
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Patients with a previous history of cancer
- Use of any other investigational agent in the last 30 days
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00673218
Start Date
June 1 2007
End Date
November 1 2012
Last Update
July 6 2012
Active Locations (1)
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1
Creighton University
Omaha, Nebraska, United States, 68131