The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Creighton University

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Omalizumab

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00657891

IgE 025 US22

Details and patient eligibility

About

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.

Full description

Must be allergic-asthma with IgE between 30 and 700 IU/ml.

Enrollment

49 patients

Sex

All

Ages

16 to 50 years old

Volunteers

No Healthy Volunteers

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