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| Sponsors and Collaborators: |
University of Mississippi Medical Center Novartis Pharmaceuticals |
|---|---|
| Information provided by: | University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier: | NCT00226200 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment |
| Official Title: | Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab |
| 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
| Responsible Party: | University of Mississippi Medical Center ( Gailen D. Marshall. MD, PhD ) |
| Study ID Numbers: | CIGE025AUS10, CIGE025AUS10 |
| Study First Received: | September 22, 2005 |
| Last Updated: | November 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00226200 |
| Health Authority: | United States: Food and Drug Administration |
|
Allergic Non allergic |
|
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Omalizumab Respiratory Hypersensitivity |
|
Respiratory System Agents Immune System Diseases Bronchial Diseases Therapeutic Uses |
Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions |
