The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Omalizumab

• Registration Number: NCT00657891
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2008-04-08
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo Injection
2	Omalizumab	Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Creighton University Medical Center; 🇺🇸 Omaha, Nebraska, United States