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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657891

Enrollment

Registered

2008-04-14

Start date

2007-03-31

Completion date

2007-10-31

Last updated

2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Allergic Asthma, Anti IgE, Xolair, Basophil, IL-13, IL-4, Histamine

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.

Interventions

DRUGOmalizumab

0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously

DRUGPlacebo

Placebo Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026