The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
This trial is active, not recruiting.
|Start date||June 2007|
|End date||November 2012|
|Trial size||25 participants|
|Trial identifier||NCT00673218, CIGE025AUS22|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
|Primary purpose||basic science|
Basophil histamine release
time frame: After 4 weeks treatment
Male or female participants from 19 years up to 50 years old.
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
|Official title||The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils|
|Principal investigator||Robert G Townley, MD|
|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.|
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