The Effect of Xolair (Omalizumab) on Allergy Blood Cells
Information source: Creighton University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Omalizumab (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Creighton University Official(s) and/or principal investigator(s): Robert G Townley, MD, Principal Investigator, Affiliation: Creighton University
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 will be mixed with to whatever the person is allergic.
Clinical Details
Official title: The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Primary outcome: To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.
Secondary outcome: To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin).
Detailed description:
Must be allergic-asthma with IgE between 30 and 700 IU/ml.
Eligibility
Minimum age: 16 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 2 year history of ragweed allergic rhinitis
- positive skin prick tests to ragweed >5 mm wheal diameter
- serum IgE <700 iU/m
Exclusion Criteria:
- 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
Locations and Contacts
Creighton University Medical Center, Omaha, Nebraska 68131, United States
Additional Information
Starting date: March 2007
Last updated: September 30, 2013
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