Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Collaborators: AZ Delta; AZ Delta Roeselare; Brugmann University Hospital; Centre Hospitalier Universitaire Dinant Godinne - UCL Namur; Centre Hospitalier Universitaire Saint Pierre; CHU de Charleroi; Erasme University Hospital; Grand Hôpital de Charleroi; KU Leuven; Universitair Ziekenhuis Brussel; University Hospital of Liege; University Hospital, Ghent; University of Liege
• Treatments: Omalizumab

Criteria

Inclusion Criteria: • 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 Criteria:

• 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.