Asthma Clinical Trial
Official title:
Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab
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.
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.
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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