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

NCT ID: NCT00673218

Last Updated: 2012-07-06

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-11-30

Brief Summary

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If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Detailed Description

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Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.

Conditions

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Allergy

Keywords

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IL13 Cytokines Basophil stimulation

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

Saline injection to match active

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.

Treatment

Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks

Group Type EXPERIMENTAL

Xolair

Intervention Type DRUG

150 to 375 mg is administered SC every 2 or 4 weeks

Interventions

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Placebo

Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.

Intervention Type DRUG

Xolair

150 to 375 mg is administered SC every 2 or 4 weeks

Intervention Type DRUG

Other Intervention Names

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Saline Omalizumab, rhumab-E25

Eligibility Criteria

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Inclusion Criteria

* Ages 19 to 50
* At least 2 year history of ragweed allergic rhinitis
* Positive skin prick tests to ragweed \>5 mm wheal diameter
* 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 2 days.
* 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

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

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

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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CIGE025AUS22

Identifier Type: -

Identifier Source: org_study_id