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Soluble CD23 Expression in Asthma Patients Treated With OMA

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ClinicalTrials.gov Identifier: NCT00226200
Recruitment Status : Terminated (Completed)
First Posted : September 26, 2005
Last Update Posted : December 1, 2008
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
University of Mississippi Medical Center

Brief Summary:
This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does allergic asthmatics.

Condition or disease Intervention/treatment
Asthma Drug: Omalizumab

Detailed Description:

This is a 1 year placebo controlled study looking at moderate to severe asthmatics (allergic or non-allergic) who are controlled by medication.

Skin testing will be done to determine the allergic status, as well as a base line IgE done. The Omalizumab is administered by injection based on weight and IgE level, (once or twice a month).

At several times during the year pulmonary function test will be done, as well blood drawn for immunological assays (CD23 and FcER1 expression, TH1/TH2 cytokines, CD23 production). A battery of questionnaires will also determine quality of life(with asthma), psychological stress measures and parameters of clinical response.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab
Study Start Date : November 2004
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources




Primary Outcome Measures :
  1. Measure of sCD23 in plasma
  2. CD23 expression on T cell correlated with spirometry, AQLQ and RQLQ.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Moderate to severe asthmatic (based on 1997 NHLBI guidelines), controlled by medication for at least 6 months, initial IgE level between 30 and 700 IU, weigh between 30 an 150 kg, otherwise healthy.

Exclusion Criteria:

Smoker, uncontrolled asthma, immunotherapy in past six weeks, other diseases


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226200


Locations
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: Gailen D Marshall, MD/PhD University of Mississippi Medical Center

Responsible Party: Gailen D. Marshall. MD, PhD, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00226200     History of Changes
Other Study ID Numbers: CIGE025AUS10
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: December 1, 2008
Last Verified: November 2008

Keywords provided by University of Mississippi Medical Center:
Allergic
Non allergic

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents