The Effect of Xolair (Omalizumab) on Allergy Blood Cells - Full Text View

Sponsors and Collaborators:	Creighton University Novartis
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00657891

Purpose

We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Condition	Intervention	Phase
Asthma	Drug: Omalizumab Drug: Placebo	Phase IV

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Omalizumab Histamine Histamine dihydrochloride Histamine phosphate

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 (Omalizumab) 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:

To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo Injection	Drug: Placebo Placebo Injection
2: Experimental Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks	Drug: Omalizumab 0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously

Detailed Description:

Must be allergic-asthma with IgE between 30 and 700 IU/ml.

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

2 year history of ragweed allergic rhinitis
positive skin prick tests to ragweed >5 mm wheal diameter
serum 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 1 week
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: NCT00657891

Locations

United States, Nebraska
Creighton University Medical Center	Recruiting
Omaha, Nebraska, United States, 68131
Contact: Lori D Mahon, BSN,RN,CCRC 402-280-5968 lmahon@creighton.edu
Contact: Suzie Quinn, BSN,RN,CCRC 402-280-5937 susanquinn@creighton.edu
Principal Investigator: Robert G Townley, MD
Sub-Investigator: Thomas B Casale, MD
Sub-Investigator: Againdra K Bewtra, MD
Sub-Investigator: Russell J Hoppe, DO
Sub-Investigator: Jeffrey R Stokes, MD
Sub-Investigator: Douglas H Jones, MD
Sub-Investigator: Manav Segal, MD
Sub-Investigator: Bina M Patel, MD
Sub-Investigator: Priya J Warrier, MD, MPH
Sub-Investigator: Lori D Mahon, BSN,RN,CCRC
Sub-Investigator: Jean A Kessler, RN, CCRC
Sub-Investigator: Janie M Misfeldt, MA, CCRC
Sub-Investigator: Francisco A Romero, MS, CCRC
Sub-Investigator: Susan A Quinn, BSN,RN,CCRC
Sub-Investigator: Anna Secor, MA
Sub-Investigator: Patrick Denier
Sub-Investigator: Jean Casale, BS, MA

Sponsors and Collaborators

Creighton University

Novartis

Investigators

Principal Investigator:

Robert G Townley, MD

Creighton University

More Information

Responsible Party:	Creighton University ( Robert G. Townley, MD )
Study ID Numbers:	IgE 025 US22
Study First Received:	April 8, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00657891
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

Allergic Asthma
Anti IgE
Xolair
Basophil

IL-13
IL-4
Histamine

Study placed in the following topic categories:

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Histamine phosphate
Asthma
Histamine
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009