SYFf2b37452a8c2492f9e0a8ad4c1ff6e8fRegistry ID: 2024-516783-29-00|UnknownPhase 4
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interventional
N/A
2 countries
22
To compare the rate and magnitude of response to omalizumab and mepolizumab in patients with severe allergic and eosinophilic asthma, in terms of annual rate of severe exacerbations (primary outcome).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2024
Actual (reported)The primary criterion for judgment will be the rate of severe exacerbation during one year in patients on omalizumab vs mepolizumab, in the overall population. An additional primary criterion will be the rate of response to omalizumab vs that for mepolizumab, in the overall and stratified population(s).
Clinical features and biomarkers (or array signatures) analyzed in blood, mucosal and urine samples will be tested for their putative ability to predict a better response to oma- or mepolizumab (theranostic value). The candidate features are age at (severe) disease onset and presence of nasal polyps or aspirin hypersensitivity as well as serum specific/total IgE ratio and blood eosinophil levels.
Asthma-related outcomes other than exacerbations – i.e. disease control reflected by ACT and ACQ6, asthma-related quality of life questionnaire reflected by AQLQ, lung function reflected by FEV1 % predicted and absolute change - as well as nasal symptoms (VAS and, for nasal polyps, endoscopic scoring) will be assessed in the oma- and mepolizumab groups, in the overall and stratified populations.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cliniques Universitaires Saint-Luc
Sint-Lambrechts-Woluwe, 1200, Belgium
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Brussels, 1020, Belgium
Centre Hospitalier Regional De La Citadelle
Liege, 4000, Belgium
Charles Pilette
First Submitted
October 30, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Centre Hospitalier Universitaire De Liege
Liege, 4000, Belgium
HUmani
Charleroi, 6042, Belgium
CHU Saint Pierre
Brussels, 1000, Belgium
CHU Helora
La Louviere, 7100, Belgium
Universitair Ziekenhuis Gent
Gent, 9000, Belgium
Centre Hospitalier Regional De Marseille
Marseille, 13015, France
Centre Hospitalier Universitaire Reims
Reims Cedex, 51092, France
Assistance Publique Hopitaux De Paris
Le Kremlin-Bicetre, 94270, France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble Cedex 09, 38043, France
Hospital Foch
Suresnes, 92150, France
Hospices Civils De Lyon
Lyon Cedex 04, 69317, France
Centre Hospitalier Universitaire De Dijon
Dijon, 21000, France
Centre Hospitalier Universitaire De Montpellier
Montpellier Cedex 5, 34091, France
CHU Besancon
Besancon Cedex, 25030, France
Les Hopitaux Universitaires De Strasbourg
Strasbourg Cedex, 67091, France
Centre Hospitalier Universitaire De La Guadeloupe
Pointe A Pitre, 97139, France
Centre Hospitalier Universitaire De Lille
Lille, 59000, France
Assistance Publique Hopitaux De Paris
Paris Cedex 18, 75877, France
Centre Hospitalier Universitaire De Toulouse
Toulouse, 31400, France