Korrelation von freiem IgE mit klinischen Parametern bei Asthma-Patienten unter Therapie mit Omalizumab, einem monoklonalen Antikörper gegen körpereigenes IgE - Freies IgE
- Conditions
- Add-on therapy to improve asthma control in patients 18-75 years of age with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
- Registration Number
- EUCTR2009-012108-15-DE
- Lead Sponsor
- Mainz University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Provision of informed consent
Indication for Xolair as earlier described according to the MA in the EU
Age 18 – 75 years
Outpatients of either sex
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Known or suspected hypersensitivity to study therapy
Pregnancy or planned pregnancy during study
Women of child-bearing potential not using acceptable contraceptive measures
insulin-dependent diabetes mellitus
chronic renal insuffiency
clinically relevant heaptic insuffiency
respiratory infection 4 weeks prior to inclusion
participating in a clinical study during the last 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Correlation of free serum IgE with clinical parameters of asthma control<br>;Secondary Objective: Correlation of free serum IgE with clinical parameters (lung function, differential blood count, nitric oxide (FeNO), immune cell function tests, sputum eosinophils, quality of life, symptoms)<br>;Primary end point(s): asthma control as a function of levels of free IgE<br>
- Secondary Outcome Measures
Name Time Method