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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   Information provided by Creighton University
First Received: March 30, 2008   Last Updated: May 6, 2008   History of Changes

March 30, 2008
May 6, 2008
June 2007
August 2008   (final data collection date for primary outcome measure)
Basophil histamine release [ Time Frame: After 4 weeks treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00673218 on ClinicalTrials.gov Archive Site
 
 
 
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

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.

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.

Phase IV
Interventional
Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Allergy
  • Drug: Placebo
  • Drug: Xolair
  • Placebo Comparator: Saline injection to match active
  • Experimental: Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
25
December 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
19 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00673218
Robert G. Townley, MD, Creighton University
CIGE025AUS22
Creighton University
Novartis
Principal Investigator: Robert G Townley, MD Creighton University
Creighton University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP