Predictive factors of response to omalizumab and mepolizumab in asthma.
- Conditions
- Adult patients (at least 18yrs-old) with severe asthma and eligible for both XOLAIR and NUCALA therapies, and agreeing on participating (signature of a written informed consent).Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-002473-19-BE
- Lead Sponsor
- Cliniques Universitaires Saint-Luc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
•Signed informed consent form (ICF),
•Age >18+ years at time of signing ICF,
•Able to comply with the study protocol, in the investigator’s judgment,
•Documented physician-diagnosed asthma ,
•Patients with severe disease and eligible to omalizumab and mepolizumab, and who have not yet received any of these therapies.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
•History of evidence of drug/substance abuse that would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or affect the patient’s ability to participate in the study, in the opinion of the investigator
•Treatment with any investigational therapy within 6 months or 5 drug half-lives prior to enrolment.
•Known sensitivity to any of the active substances or their excipients to be administered during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method