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The Effect of Xolair (Omalizumab) on Allergy Blood Cells

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00657891
First received: April 8, 2008
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

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: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00657891     History of Changes
Other Study ID Numbers: IgE 025 US22
Study First Received: April 8, 2008
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Allergic Asthma
Anti IgE
Xolair
Basophil
 IL-13
IL-4
Histamine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 21, 2013