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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

Page last updated: August 23, 2015

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