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

July 3, 2012 updated by: Creighton University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Saline injection to match active
Drug: Placebo
Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.
Other Names:
  • Saline
Experimental: Treatment
Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks
Drug: Xolair
150 to 375 mg is administered SC every 2 or 4 weeks
Other Names:
  • Omalizumab, rhumab-E25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Basophil histamine release
Time Frame: After 4 weeks treatment
After 4 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

Novartis

Investigators

  • Principal Investigator: Robert G Townley, MD, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

March 30, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIGE025AUS22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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