Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: PREDICTUMAB, an open-label, controlled, randomized multinational pragmatic trial.
Key facts
- Where
- Besancon Cedex, Dijon, Grenoble Cedex 09, Le Kremlin-Bicetre, Lille, Lyon Cedex 04, Marseille, Montpellier Cedex 5, Paris Cedex 18, Pointe à Pitre, Reims Cedex, Strasbourg Cedex, Suresnes és Toulouse, FranciaországSee the 14 sites
- Phase
- 4. fázis
Where in Franciaország
- CHU BesanconBesancon Cedex, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de DijonDijon, FranciaországNo longer taking part
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 09, FranciaországNo longer taking part
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de LilleLille, FranciaországNo longer taking part
- Hospices Civils De LyonLyon Cedex 04, FranciaországNo longer taking part
- Centre Hospitalier Regional De MarseilleMarseille, FranciaországNo longer taking part
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországNo longer taking part
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de la GuadeloupePointe à Pitre, FranciaországNo longer taking part
- Centre Hospitalier Universitaire ReimsReims Cedex, FranciaországNo longer taking part
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranciaországNo longer taking part
- Hospital FochSuresnes, FranciaországNo longer taking part
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cliniques Universitaires Saint-Luc
- Trial code
- EU 2024-516783-29-00
- Record updated
- 2025. április 15.
- Original description
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).Read full original descriptionShow less
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).
Inclusion: Signed informed consent form (ICF); Age >18+ years (18-90 years old) at time of signing ICF; Able to comply with the study protocol, in the investigator’s judgment; Documented physician-diagnosed asthma; Eligible to omalizumab and mepolizumab and who have not yet received any of these therapies.
Exclusion: Patient already currently/actively enrolled in a clinical therapeutic trial (testing another drug); the concomitant inclusion in a Registry, which may include biosampling, is not an exclusion criterion; 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; Difficult to treat asthma and others severe respiratory diseases; Active malignancy or malignancy in remission over less than 5 years; Protected subjects (sous tutelle or curatelle), patients who are unable to express their consent, subjects who are deprived of liberty, subjects who are hospitalized without consent, subjects who are admitted in a health-care or social institute with another aim than that of the research, inclusion in an emergency situation, patient who is subject to a court order; Pregnant, post-partum or lactating women; Known sensitivity to any of the active substances or their excipients to be administered during the study; Patient not affiliated to a health insurance plan (FR).