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

• Status: Unknown status
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creighton University
• Collaborator: Novartis
• Treatments: Omalizumab

Criteria

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