The Effect of Xolair (Omalizumab) on Allergy Blood Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657891
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : October 1, 2013
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Creighton University

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Omalizumab Drug: Placebo Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Study Start Date : March 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo Injection
Drug: Placebo
Placebo Injection
Experimental: 2
Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks
Drug: Omalizumab
0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
Other Names:
  • Xolair
  • rhumabe35

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657891

United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Novartis Pharmaceuticals
Principal Investigator: Robert G Townley, MD Creighton University

Responsible Party: Creighton University Identifier: NCT00657891     History of Changes
Other Study ID Numbers: IgE 025 US22
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Creighton University:
Allergic Asthma
Anti IgE

Additional relevant MeSH terms:
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents