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    Summary
    EudraCT Number:2019-002724-33
    Sponsor's Protocol Code Number:RECHMPL19-0069
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-002724-33
    A.3Full title of the trial
    Eosinophil-driven corticotherapy for patients hospitalized for COPD exacerbation: a double-blind, randomized, controlled trial

    Intérêt de la corticothérapie guidée par l’éosinophilie sanguine chez les patients hospitalisés pour exacerbation de BPCO: essai contrôlé, randomisé en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eosinophil-driven corticotherapy for patients hospitalized for COPD exacerbation: a double-blind, randomized, controlled trial
    Intérêt de la corticothérapie guidée par l’éosinophilie sanguine chez les patients hospitalisés pour exacerbation de BPCO: essai contrôlé, randomisé en double aveugle
    A.3.2Name or abbreviated title of the trial where available
    eo-Drive
    eo-Drive
    A.4.1Sponsor's protocol code numberRECHMPL19-0069
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital of Montpellier
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointAnne Cadène
    B.5.3 Address:
    B.5.3.1Street AddressDRI, Pav 32-39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post codeFrance
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467330814
    B.5.5Fax number0033467339172
    B.5.6E-maila-cadene@chu-montpellier.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name prednisone
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameprednisone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study population corresponds to patients hospitalized for COPD exacerbation
    La population de l'étude correspond aux patients hospitalisés pour exacerbation de BPCO
    E.1.1.1Medical condition in easily understood language
    The study population corresponds to patients hospitalized for COPD exacerbation
    La population de l'étude correspond aux patients hospitalisés pour exacerbation de BPCO
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    L'objectif principal de l'étude est de comparer les taux d'échec de traitement entre un groupe de patients éosinophiles (éosinophilie sanguine > 2% au jour 1 de l'hospitalisation) hospitalisés pour une exacerbation de la BPCO traitée par corticothérapie et un groupe similaire traité par placebo.
    E.2.2Secondary objectives of the trial
    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.
    Deuxièmement, les taux d'échec du traitement seront également comparés entre un groupe de patients non éosinophiles hospitalisés pour une exacerbation de la BPCO traitée par corticothérapie et un groupe similaire traité par placebo. Les bras d'étude seront également comparés sur d'autres aspects d'efficacité et de sécurité:
    • rapidité de récupération lors de l'hospitalisation initiale;
    • effets secondaires des corticostéroïdes / comorbidités induites;
    • changements dans les symptômes et les épisodes d'exacerbation;
    • fonction pulmonaire, utilisation d'oxygène et ventilation;
    • trajectoires des patients et utilisation des ressources (survie, consultations, épisodes d’hospitalisation, médicaments);
    • consommation de médicaments (en particulier en ce qui concerne la gestion de la BPCO, les exacerbations et les comorbidités induites);
    • état de santé, qualité de vie, activité / handicap;
    • sécurité des patients / événements indésirables en général.
    E.2.3Trial contains a sub-study No
    E.3Principal 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:
    oPost-bronchodilator FEV1/FVC < 70% of predicted values
    o> 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
    • Minimum age: 40 years
    • Maximum age: 85 years
    • 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.
    • Patient adulte admis dans un centre participant à l’étude (urgences, réanimation, maladies respiratoires) pour exacerbation aigüe de BPCO
    • Pour les patients avec une BPCO connue : BPCO définie selon les critères de GOLD 2018 :
    o VEMS/CVF post bronchodilatation < 70 % des valeurs prédites
    o Historique de consommation de tabac > 10 paquets/année
    • Pour les cas d’épisodes de BPCO non confirmés par spirométrie : les symptômes reportés en accord avec les critères GOLD seront pris en compte pour le diagnostic, mais si le diagnostic par spirométrie n’est pas confirmé durant le suivi, le patient sera exclu.
    • Recueil du consentement éclairé, écrit et signé ou respect de la procédure juridique pour les situations d’urgence
    • Age minimal : 40 ans
    • Age maximal : 85 ans
    • Affiliation ou bénéficiaire d’un système national d’assurance maladie
    • Patient disponible pour un suivi de 3 mois. Compréhension et acceptation du protocole.
    E.4Principal exclusion criteria
    • 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
    • White blood cell formula already performed and distributed to implicated teams
    • Directives for limitation-of-care (“LATA” in French) already established
    • Sujet incapable de lire ou d’écrire, barrière de la langue
    • Sujet employé par le promoteur ou l’investigateur ou présentant des liens d’intérêt avec ces derniers
    • Femmes enceintes ou allaitantes
    • Patient privé de liberté par décision judiciaire ou administrative
    • Majeur (adulte) protégé par la loi (sous toute forme de tutelle)
    • Patient ayant déjà participé à l’étude
    • Patient ayant participé à un autre protocole de recherche interventionnelle au cours des 3 derniers mois ou en cours de participation
    • Patient dans une période d’exclusion relative à une autre étude
    • Administration de corticothérapie systémique sur le long terme depuis plus d’un mois avant l’inclusion
    • Patient ayant déjà reçu une corticothérapie systémique supérieure à 1 mg/kg dans les 48 heures avant l’inclusion
    • Patient intubé-ventilé
    • Administration de médicament expérimental par voie orale impossible
    • Cancer dans les 12 derniers mois
    • Diagnostic d’asthme actuel
    • Médicaments biologiques suivants : Benralizumab, reslizumab, mepolizumab, dupilumab
    • Patient admis pour une autre raison, incluant mais non limitée à l’embolisme pulmonaire, pneumothorax, arrêt cardiaque.
    • Allergie connue aux corticostéroïdes
    • Numération des leucocytes du patient déjà réalisée et connue par les équipes impliquées dans l’étude
    • Décisions de limitation ou d’arrêt des thérapeutiques actives (LATA) déjà établies
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is % treatment failure at 3 months
    Le critère de jugement principal correspond au pourcentage d'échec du traitement à 3 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    E.5.2Secondary end point(s)
    1)The speed of initial recovery
    2)Presence /absence of comorbidities or steroid side effects
    3)Exacerbations
    4)Pulmonary function, oxygen and ventilation requirements
    5)Patient trajectories
    6) Médications
    7) Symptoms, physical activity levels and quality of life
    8) Targeted biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) During initial hospitalisation
    2) Throughout the study, 3 months
    3) Throughout the study, 3 months
    4) At hospital discharge, and during follow-up at 3 months
    5)Throughout the study
    6)Throughout the study
    7)Throughout the study, 3 months
    8)Throughout the study, 3 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Aucun
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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