Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation
NCT ID: NCT04234360
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2021-10-12
2025-01-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Eosinophil count > 2%; corticotherapy
Eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
5 days of systemic corticotherapy (prednisone)
Patients randomized to this arm will receive 40 mg prednisone per os per day for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Eosinophil count <= 2%; corticotherapy
Non-eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
5 days of systemic corticotherapy (prednisone)
Patients randomized to this arm will receive 40 mg prednisone per os per day for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Eosinophil count > 2%; placebo
Eosinophilic patients randomized to this arm will receive 5 days of placebo.
5 days of placebo
Patients randomized to this arm will receive an appropriate placebo per os for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Eosinophil count <= 2%; placebo
Non-eosinophilic patients randomized to this arm will receive 5 days of placebo.
5 days of placebo
Patients randomized to this arm will receive an appropriate placebo per os for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Interventions
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5 days of systemic corticotherapy (prednisone)
Patients randomized to this arm will receive 40 mg prednisone per os per day for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
5 days of placebo
Patients randomized to this arm will receive an appropriate placebo per os for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
40 Years
85 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Locations
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CHU Amiens
Amiens, , France
CHU Brest - Hôpital Caval Blanche
Brest, , France
Clinique du Parc
Castelnau-le-Lez, , France
Centre hospitalier intercommunal de Créteil
Créteil, , France
CH Libourne
Libourne, , France
CHRU Lille
Lille, , France
Hospice Civils de Lyon
Lyon, , France
APHM - Hôpital Nord
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nancy
Nancy, , France
CHU Nîmes
Nîmes, , France
APHP - Hopital Européen Georges Pompidou
Paris, , France
APHP - Hôpital BICHAT
Paris, , France
APHP - Hôpital Cochin
Paris, , France
APHP - Hôpital Universitaire Pitié-Salpétrière
Paris, , France
APHP - Hôpital Universitaire Pitié-Salpétrière
Paris, , France
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, , France
CHU Reims
Reims, , France
CH Roubaix
Roubaix, , France
CHRU Strasbourg
Strasbourg, , France
Hôpital Larrey CHU Toulouse
Toulouse, , France
Hôpital Nord Franche-Comté
Trévenans, , France
Countries
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Central Contacts
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Facility Contacts
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Claire ANDREJAK
Role: primary
Francis COUTURAUD
Role: primary
Marie GUEGAN
Role: backup
Khuder ALAGHA
Role: primary
Laurent PORTEL
Role: primary
Gilles DEVOUASSOUX
Role: primary
Pascal CHANEZ
Role: primary
Arnaud BOURDIN
Role: primary
Anne GUILLAUMOT
Role: primary
Nathalie PLOUVIER
Role: primary
Thibaud SOUMAGNE
Role: primary
Camille TAILLE
Role: primary
Nicolas ROCHE
Role: primary
Morgane FAURE
Role: primary
Jesus GONZALEZ
Role: primary
Maeva ZYSMAN
Role: primary
Gaétan DESLEE
Role: primary
Romain KESSLER
Role: primary
Elise NOEL-SAVINA
Role: primary
References
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Suehs CM, Zysman M, Chenivesse C, Burgel PR, Couturaud F, Deslee G, Berger P, Raherison C, Devouassoux G, Brousse C, Roche N, Molimard M, Chinet T, Devillier P, Chanez P, Kessler R, Didier A, Martinat Y, Le Rouzic O, Bourdin A. Prioritising outcomes for evaluating eosinophil-guided corticosteroid therapy among patients with acute COPD exacerbations requiring hospitalisation: a Delphi consensus study. BMJ Open. 2020 Jul 1;10(7):e035811. doi: 10.1136/bmjopen-2019-035811.
Related Links
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eo-Drive on the Open Science Framework
Other Identifiers
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2019-002724-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LIC-18-18-0374
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RECHMPL19_0069 UF 7771
Identifier Type: -
Identifier Source: org_study_id
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