Soluble CD23 Expression in Asthma Patients Treated With OMA
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab|
- Measure of sCD23 in plasma
- CD23 expression on T cell correlated with spirometry, AQLQ and RQLQ.
|Study Start Date:||November 2004|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226200
|United States, Mississippi|
|University of Mississippi Medical Center|
|Jackson, Mississippi, United States, 39216|
|Principal Investigator:||Gailen D Marshall, MD/PhD||University of Mississippi Medical Center|