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

This study is ongoing, but not recruiting participants.
Study NCT00673218.   Last updated on May 6, 2008.   Information provided by Creighton University

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Descriptive Information Fields
Brief Title  The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Official Title  The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Brief 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.

Detailed 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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary Outcome Measure  Basophil histamine release [ Time Frame: After 4 weeks treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Allergy
Intervention  Drug: Placebo
Drug: Xolair
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  25
Start Date  June 2007
Completion Date December 2008
Eligibility 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
Gender Both
Ages 19 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00673218
Organization ID CIGE025AUS22
Secondary IDs ††
Study Sponsor  Creighton University
Collaborators †† Novartis
Investigators 
Principal Investigator:     Robert G Townley, MD     Creighton University    
Information Provided By Creighton University
Verification Date May 2008
First Received Date  March 30, 2008
Last Updated Date May 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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