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The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omalizumab

Placebo

About this trial

This is an interventional basic science trial for Asthma focused on measuring Allergic Asthma, Anti IgE, Xolair, Basophil, IL-13, IL-4, Histamine

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Creighton University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo Injection

Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks

Outcomes

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.

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).

Full Information

NCT ID

NCT00657891

First Posted

April 8, 2008

Last Updated

September 30, 2013

Sponsor

Creighton University

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00657891

Brief Title

The Effect of Xolair (Omalizumab) on Allergy Blood Cells

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creighton University

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo Injection

Arm Title

Arm Type

Experimental

Arm Description

Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair, rhumabe35

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Injection

Primary Outcome Measure Information:

Title

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert G Townley, MD

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Xolair (Omalizumab) on Allergy Blood Cells

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