The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Asthma Clinical Trial

Official title:

The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657891
• Other study ID #: IgE 025 US22
• Status: Completed
• Phase: Phase 4
• First received: April 8, 2008
• Last updated: September 30, 2013
• Start date: March 2007
• Est. completion date: October 2007

Study information

• Verified date: September 2013
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab
0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
• Placebo
Placebo Injection

Locations

Country	Name	City	State
United States	Creighton University Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	No
Secondary	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).		1 year	No