Status:
COMPLETED
The Effect of Xolair (Omalizumab) on Allergy Blood Cells
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
16-50 years
Phase:
PHASE4
Brief Summary
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells...
Detailed Description
Must be allergic-asthma with IgE between 30 and 700 IU/ml.
Eligibility Criteria
Inclusion
- 2 year history of ragweed allergic rhinitis
- positive skin prick tests to ragweed \>5 mm wheal diameter
- serum 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 1 week
- 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 :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00657891
Start Date
March 1 2007
End Date
October 1 2007
Last Update
October 1 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Creighton University Medical Center
Omaha, Nebraska, United States, 68131