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

April 8, 2008
September 30, 2013
March 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
To determine if Xolair inhibits basophil leukotriene secretion and to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with specific allergen versus anti-IgE versus calcium ionophore. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00657891 on ClinicalTrials.gov Archive Site
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 ]
To determine the effect of Xolair on IL-4 andIL-13 secretion. To compare the effect of Xolair on IL-4 versus IL-13 secretion from basophils stimulated with allergen, anti-IgE and calcium ionophore (ionomycin). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effect of Xolair (Omalizumab) on Allergy Blood Cells
The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Asthma
  • Drug: Omalizumab
    0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
    Other Names:
    • Xolair
    • rhumabe35
  • Drug: Placebo
    Placebo Injection
  • Placebo Comparator: 1
    Placebo Injection
    Intervention: Drug: Placebo
  • Experimental: 2
    Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks
    Intervention: Drug: Omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00657891
IgE 025 US22
No
Creighton University
Creighton University
Novartis Pharmaceuticals
Principal Investigator: Robert G Townley, MD Creighton University
Creighton University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP