Omalizumab for Asthma with Non-detectable Sensitization to an Aeroallerge

Withdrawn

Conditions: Asthma
10006436

Registration Number: NL-OMON42417

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 60

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

* 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the expression levels of Fc*RI on basophils before<br /><br>and after four-month omalizumab treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical evaluation<br /><br>* Spirometry (FEV1, VC, FVC)<br /><br>* Lung Volumes (RV, TLC, ITGV)<br /><br>* Asthma control Questionnaire<br /><br>* Blood eosinophil count<br /><br>* Number of exacerbations experienced during treatment period<br /><br>* Global assessment of treatment efficacy<br /><br>Immunological parameters<br /><br>* Serum free-IgE levels<br /><br>* Antigen-specific IgE levels<br /><br>* Expression of IgE receptors on PBMC<br /><br>* Dendritic cell markers and function<br /><br>* Serum cytokine levels<br /><br>* Basophil sensitivity<br /><br>* T cell proliferation assays<br /><br>* B cell profiling</p><br>