The Effect of Xolair (Omalizumab) on Allergy Blood Cells

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00657891
First received: April 8, 2008
Last updated: September 30, 2013
Last verified: September 2013
  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:


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 ]

Enrollment: 49
Study Start Date: March 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 30, 2013
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 August 21, 2014