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.

First Received: March 30, 2008 Last Updated: May 6, 2008 History of Changes

Sponsors and Collaborators:	Creighton University Novartis
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00673218

Purpose

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.

Condition	Intervention	Phase
Allergy	Drug: Placebo Drug: Xolair	Phase IV

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Further study details as provided by Creighton University:

Primary Outcome Measures:

Basophil histamine release [ Time Frame: After 4 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Saline injection to match active	Drug: Placebo Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.
Treatment: Experimental Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks	Drug: Xolair 150 to 375 mg is administered SC every 2 or 4 weeks

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.

Eligibility

Ages Eligible for Study:	19 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673218

Locations

United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Novartis

Investigators

Principal Investigator:

Robert G Townley, MD

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University ( Robert G. Townley, MD )
Study ID Numbers:	CIGE025AUS22
Study First Received:	March 30, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00673218 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

IL13
Cytokines
Basophil stimulation

Study placed in the following topic categories:

Hypersensitivity
Omalizumab

ClinicalTrials.gov processed this record on May 07, 2009