The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Creighton University

Status and phase

Unknown

Phase 4

Conditions

Allergy

Treatments

Drug: Xolair

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00673218

CIGE025AUS22

Details and patient eligibility

About

If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Full description

Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.

Enrollment

25 estimated patients

Sex

All

Ages

19 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ages 19 to 50
At least 2 year history of ragweed allergic rhinitis
Positive skin prick tests to ragweed >5 mm wheal diameter
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 2 days.
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