The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00657891

Run by

Creighton University

People needed

49

Starts

2007-03-01

Expected to finish

2007-10-01

Last updated by the study team

2013-10-01

Who can join

Age: 16 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 2 year history of ragweed allergic rhinitis
• positive skin prick tests to ragweed >5 mm wheal diameter
• serum IgE <700 iU/m

You may not qualify if…

• 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

Where it is running

• Creighton University Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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