Soluble CD23 Expression in Asthma Patients Treated With OMA
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Purpose
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 | Intervention |
|---|---|
|
Asthma |
Drug: Omalizumab |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind 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.
| Estimated Enrollment: | 80 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Gailen D. Marshall. MD, PhD, University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier: | NCT00226200 History of Changes |
| Other Study ID Numbers: | CIGE025AUS10, CIGE025AUS10 |
| Study First Received: | September 22, 2005 |
| Last Updated: | November 26, 2008 |
| Health Authority: | United States: Food and Drug Administration |
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 Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013