Informations générales (source: ClinicalTrials.gov)
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial (eo-Drive)
Interventional
Phase 3
University Hospital, Montpellier (Voir sur ClinicalTrials)
octobre 2021
janvier 2025
29 juin 2024
The primary objective of this study is to compare treatment failure rates between a group
of eosinophilic (eosinophilia > 2% on day 1 of hospitalization) patients hospitalised for
a COPD exacerbation treated via corticotherapy versus a similar group treated via
placebo.
Secondarily, treatment failure rates will also be compared between a group of
non-eosinophilic patients hospitalised for a COPD exacerbation treated via corticotherapy
versus a similar group treated via placebo. Study arms will also be compared for
additional aspects of efficacy and safety:
- speed of recovery during the initial hospitalization;
- corticosteroid side effects / induced comorbidities;
- changes in symptoms and episodes of exacerbation;
- pulmonary function, oxygen use and ventilation;
- patient trajectories and resource use (e.g. survival, consults, episodes of
hospitalization, medications);
- drug consumption (especially as relates to COPD management, exacerbations and
induced comorbidities);
- health status, quality of life, activity/disability;
- patient safety / adverse events in general.
Eosinophilia thresholds optimizing the prediction of corticosteroid response and COPD
outcomes will be re-evaluated. The relationships between corticosteroid response and key
biomarkers (e.g. infectious groups) will be thoroughly explored, including within
eosinophil strata. Potential gender subgroups differences will also be evaluated.
Finally, in prevision of further exploratory studies, a biological collection and an
imaging library will be created in association with this protocol. The biological
collection will be used to explore the genetic basis and physiology linked with treatment
response, gender and patient trajectories. The image library will be used as a platform
for the exploration of new imaging markers developed, for example, via machine learning
and affiliated techniques.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Camille TAILLE | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Nicolas ROCHE | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Thibaud SOUMAGNE | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hôpital Nord - Marseille - France | Pascal CHANEZ | Contact (sur clinicalTrials) | |||
| CH Roubaix - Roubaix - France | Contact (sur clinicalTrials) | ||||
| CHRU Strasbourg - Strasbourg - France | Romain KESSLER | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Hôpital Haut Lévêque - Pessac - France | Maeva ZYSMAN | Contact (sur clinicalTrials) | |||
| CHU Brest - Hôpital Caval Blanche - Brest - France | Francis COUTURAUD | Contact (sur clinicalTrials) | |||
| CHU Montpellier - Montpellier - France | Arnaud BOURDIN | Contact (sur clinicalTrials) | |||
| CHU Nancy - Nancy - France | Anne GUILLAUMOT | Contact (sur clinicalTrials) | |||
| Hôpital Nord Franche-Comté - Trévenans - France | Contact (sur clinicalTrials) | ||||
| Hospice Civils de Lyon - Lyon - France | Gilles DEVOUASSOUX | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Hôpital Universitaire Pitié-Salpétrière - Paris - France | Jesus GONZALEZ | Contact (sur clinicalTrials) | |||
| Centre hospitalier intercommunal de Créteil - Créteil - France | Contact (sur clinicalTrials) | ||||
| CH Libourne - Libourne - France | Laurent PORTEL | Contact (sur clinicalTrials) | |||
| CHRU Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens - Amiens - France | Claire ANDREJAK | Contact (sur clinicalTrials) | |||
| CHU Nîmes - Nîmes - France | Nathalie PLOUVIER | Contact (sur clinicalTrials) | |||
| CHU Reims - Reims - France | Gaétan DESLEE | Contact (sur clinicalTrials) | |||
| Clinique du Parc - Castelnau-le-Lez - France | Khuder ALAGHA | Contact (sur clinicalTrials) | |||
| Hôpital Larrey CHU Toulouse - Toulouse - France | Elise NOEL-SAVINA | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patients admitted to a participating hospital (ward, ICU or emergency
services) for an acute COPD exacerbation
- For patients with known COPD: COPD defined according to GOLD 2018 criteria: (1)
Post-bronchodilator FEV1/FVC < 70% of predicted values; (2) > 10 pack years smoking
history
- For incident COPD cases with no spirometric history: symptoms and exposure according
to GOLD 2018 report will be considered for the diagnosis, but if the spirometric
diagnosis is not confirmed during follow-up, then the patient will be excluded
- Signed consent has been obtained, or the appropriate emergency procedure (under
French law) allows enrolment
- Subjects must be covered by public health insurance
- Patient available for 3 months of follow-up. Subjects must be able to attend all
scheduled visits and to comply with all trial procedures.
- Adult patients admitted to a participating hospital (ward, ICU or emergency
services) for an acute COPD exacerbation
- For patients with known COPD: COPD defined according to GOLD 2018 criteria: (1)
Post-bronchodilator FEV1/FVC < 70% of predicted values; (2) > 10 pack years smoking
history
- For incident COPD cases with no spirometric history: symptoms and exposure according
to GOLD 2018 report will be considered for the diagnosis, but if the spirometric
diagnosis is not confirmed during follow-up, then the patient will be excluded
- Signed consent has been obtained, or the appropriate emergency procedure (under
French law) allows enrolment
- Subjects must be covered by public health insurance
- Patient available for 3 months of follow-up. Subjects must be able to attend all
scheduled visits and to comply with all trial procedures.
- Subject unable to read or write; language barrier
- Subject who is in a dependency or employment with the sponsor or investigator
- Pregnancy or lactation
- Patients who are prisoners or under other forms of judicial protection
- Patients under any kind of guardianship
- The patient has already participated in the present protocol
- The patient is participating in another interventional study or has done so in the
past 3 months
- The patient is in an exclusion period determined by a previous study
- The patient has been taking long-term systemic corticosteroids for longer than 1
month prior to inclusion
- The patient has already received > 1 mg/kg of systemic corticotherapy in the past
48h
- Intubated-ventilated patient
- Administration of oral experimental drug is impossible
- Cancer within the last 12 months
- Current diagnosis of Asthma
- T2-inflammation targeting biologics (Benralizumab, reslizumab, mepolizumab,
dupilumab) treatment
- Admitted for any other reason including, but not limited to, pulmonary embolism,
pneumothorax, heart failure
- Known allergy to corticosteroids
- Consideration of a potential negative drug interaction with corticosteroids (at the
investigator's discretion)
- White blood cell formula already performed and distributed to implicated teams
- Directives for limitation-of-care ("LATA" in French) already established
- SARS-Cov2 positive test carry out during the COPD exacerbation