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The Effect of Xolair (Omalizumab) on Allergy Blood Cells

NCT ID: NCT00657891

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-10-31

Brief Summary

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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

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

Conditions

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Asthma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Placebo Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Injection

2

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

Group Type EXPERIMENTAL

Omalizumab

Intervention Type DRUG

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

Interventions

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Omalizumab

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

Intervention Type DRUG

Placebo

Placebo Injection

Intervention Type DRUG

Other Intervention Names

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Xolair rhumabe35

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert G Townley, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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IgE 025 US22

Identifier Type: -

Identifier Source: org_study_id