Asthma
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Initiation of omalizumab therapy as part of the medical treatment, based on the indication of severe or allergic asthma (group 1) or severe non-atopic asthma (group 2). * Serum IgE levels and body weight within current dosing guidelines (Dosing and administration guidelines for XOLAIR. http://www.xolairhcp.com/xolairhcp/dosing-and-administration.html) * Aged between 18 and 65 years old * Written informed consent
Exclusion criteria
Exclusion criteria: * Clinical diagnosis other than asthma that may interfere with immunological assessments * No initiation of omalizumab treatment * Current or former smokers with a > 10 pack-year history * Treatment of an asthma exacerbation in the 6 weeks prior study entry * Other indications for omalizumab treatment such as ABPA, urticaria, severe food allergies * Pregnancy or breastfeeding * Participation in intervention studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the expression levels of Fc*RI on basophils before and after four-month omalizumab treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation * Spirometry (FEV1, VC, FVC) * Lung Volumes (RV, TLC, ITGV) * Asthma control Questionnaire * Blood eosinophil count * Number of exacerbations experienced during treatment period * Global assessment of treatment efficacy Immunological parameters * Serum free-IgE levels * Antigen-specific IgE levels * Expression of IgE receptors on PBMC * Dendritic cell markers and function * Serum cytokine levels * Basophil sensitivity * T cell proliferation assays * B cell profiling | — |
Countries
Netherlands
Outcome results
None listed