This research is being done to test whether differences in blood cells at baseline (start of the study) can be used to predict how well omalizumab will work in a patient. Omalizumab (Xolair) is a drug approved by the U.S. Food and Drug Administration (FDA) to treat asthma. Studies show that omalizumab improves the symptoms of asthma but some people experience better improvement than others.
From a therapeutic perspective, the study will determine whether changes in the peripheral blood basophil response to crosslinking anti-IgE Ab during treatment with omalizumab predicts the clinical efficacy of treatment with the drug. Secondary outcomes measures would focus on whether the starting level of anti-IgE-mediated histamine release, or the changes syk expression or its starting level would be sufficient to predict the clinical outcome. The study is a single-site trial to evaluate the utility of baseline basophil measures to predict the efficacy of subcutaneously administered omalizumab as an add-on therapy for the treatment of adult patients 18-75 years old who have been diagnosed with moderate to severe asthma according to current approved guidelines. Patients will be treated with omalizumab according to the standard FDA approved dosing table for a period of 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, United States
Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab
Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response
Time frame: baseline and 26 weeks
Changes in Syk Expression
Change in syk expression. Syk is a signaling molecule that is the first downstream event in IgE receptor activation of basophils.
Time frame: baseline and 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.