Status:
UNKNOWN
Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
University Hospital, Ghent
University of Liege
Conditions:
Severe Asthma
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Pragmatic trial to define the magnitude and the predictive factors of the response to omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to both therapies.
Detailed Description
Title "PREDICTUMAB: Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: a multicenter, open, active-controlled, randomized trial in a...
Eligibility Criteria
Inclusion
- • 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03476109
Start Date
May 10 2019
End Date
December 31 2024
Last Update
October 27 2022
Active Locations (13)
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1
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium, 1090
2
CHU de Charleroi
Charleroi, Hainaut, Belgium, 6000
3
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium, 6000
4
Katholieke Universiteit Leuven
Leuven, Vlaams Brabant, Belgium, 3000