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    Summary
    EudraCT Number:2019-001726-99
    Sponsor's Protocol Code Number:P17/15
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-26
    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 number2019-001726-99
    A.3Full title of the trial
    Comparison of corticosteroids versus placebo on duration of ventilatory support during severe acute exacerbations of COPD patients in the intensive care unit: a multicentre randomized controlled trial, CORTICOP.
    Comparaison des corticoïdes vs placebo sur la durée de l’assistance ventilatoire lors des exacerbations aiguës sévères de BPCO en Réanimation : Essai clinique randomisé, contrôlé, en double aveugle, CORTICOP;
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of corticosteroids versus placebo on duration of ventilatory support during severe acute exacerbations of COPD patients in the intensive care unit: a multicentre randomized controlled trial, CORTICOP.
    Comparaison des corticoïdes vs placebo sur la durée de l’assistance ventilatoire lors des exacerbations aiguës sévères de BPCO en Réanimation : Essai clinique randomisé, contrôlé, en double aveugle, CORTICOP
    A.3.2Name or abbreviated title of the trial where available
    CORTICOP
    A.4.1Sponsor's protocol code numberP17/15
    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 SponsorCentre Hospitalier de Versailles
    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 supportDGOS PHRC-N
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier de Versailles
    B.5.2Functional name of contact pointLaure MORISSET
    B.5.3 Address:
    B.5.3.1Street Address177, rue de Versailles
    B.5.3.2Town/ cityLE CHESNAY Cedex
    B.5.3.3Post code78157
    B.5.3.4CountryFrance
    B.5.4Telephone number33139.23.97.85
    B.5.5Fax number33139.23.97.73
    B.5.6E-maillmorisset@ch-versailles.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 METHYLPREDNISOLONE
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN S.A.S
    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.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe acute exacerbations of Chronic Obstructive Pulmonary Disease
    Exacerbations aiguës sévères de Broncho-Pneumopathie Chronique Obstructive
    E.1.1.1Medical condition in easily understood language
    Severe acute exacerbations of Chronic Obstructive Pulmonary Disease
    Exacerbations aiguës sévères de Broncho-Pneumopathie Chronique Obstructive
    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
    To determine if the systemic administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.
    Déterminer si l’administration d’une corticothérapie systémique, comparée au placebo, augmente le nombre de jours vivant et sans assistance ventilatoire à J28 chez les patients atteints de BPCO admis en Réanimation pour une exacerbation aiguë sévère nécessitant une assistance ventilatoire, invasive ou non-invasive.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of corticosteroids administration, as compared to placebo on :
    - mechanical ventilation and support
    - side effects of corticosteroids
    - lenght of stay
    - mortality
    - COPD exacerbations case

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients aged ≥ 40 years, man or woman
    2) Strongly suspected or documented COPD defined by all the following criterias :
    - Persistent respiratory symptoms (dyspnoea, chronic cough or sputum production)
    - History of exposure to a risk factor such as tobacco smoke
    - If available, pulmonary function tests showing airflow limitation that is not fully reversible (post-bronchodilator ratio of forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio < 0.7)
    3) ACRF, defined by the presence of the two following criteria:
    - COPD exacerbation defined by a change in the patient baseline respiratory symptoms: dyspnoea, cough or sputum (volume or purulence) for at least 24 hours and requiring a change in regular respiratory medication
    - Acute respiratory failure (defined by clinical signs of excessive muscle activity: polypnea ≥ 30 breaths /min or use of accessory respiratory muscles) requiring ventilatory support, either invasive (implemented because of respiratory distress) or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
    - Acute respiratory failure < 24h
    4) Admission to an ICU, a step-up unit or a respiratory care unit
    5) Written Informed consent from the patient or his surrogates. In patients who are not able to consent on admission (i.e., because of hypercapnic encephalopathy) and in absence of a substitute decision maker, an emergency inclusion procedure will be allowed, with a mandatory delayed consent
    6) Affiliation to (or benefit from) French health insurance system.
    1) Âge ≥ 40 ans
    2) BPCO documentée ou fortement suspectée définie par tous les critères suivants :
    -Symptômes respiratoires chroniques (dyspnée, toux ou expectorations)
    -Exposition à un facteur de risque tel que la fumée de tabac
    -Si disponible, EFR montrant un syndrome obstructif non ou partiellement réversible (rapport post-bronchodilatateur VEMS/ CV < 0.7)
    3) Exacerbation aiguë sévère, définie par la présence des 2 critères suivants :
    - Exacerbation de BPCO définie par une aggravation des symptômes habituels du patient, pendant au moins 24h et nécessitant une intensification du traitement médical
    - Détresse respiratoire aiguë (polypnée ≥ 30 cycles.min-1 ou l’utilisation des muscles respiratoires accessoires) nécessitant un support ventilatoire, invasif (introduit en raison de la détresse respiratoire) ou non-invasif (introduit en raison d’une acidose hypercapnique avec PaCO2 ≥ 45 mmHg et pH ≤ 7.35).
    4) Admission en Réanimation, Unité de Surveillance Continue ou Unité de Soins Intensifs
    5) Consentement de participation du patient ou d’un proche. Si le patient n’est pas capable de donner son consentement et si aucun proche n’est présent, une procédure d’inclusion en urgence est possible. Dans ce dernier cas, un consentement de poursuite est nécessaire.
    6) Affiliation au système de soin/sécurité sociale
    E.4Principal exclusion criteria
    Patient will not be included if they present any of the following criteria
    1) Previous diagnostic of asthma, according to “GINA” international guidelines
    2) Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
    3) Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
    4) Pneumothorax at randomization
    5) Extracorporeal life support (ECMO or ECCO2R) at randomization
    6) Moribund patient life expectancy < 3 months
    7) Pregnancy
    8) Patients protected by law
    9) Exclusion period due to other clinical trial enrolment which can influence primary outcome
    10) Previous inclusion in the present study.
    1) Asthme connu (selon les critères des recommandations internationales “GINA”)
    2) Utilisation de corticoïdes systémiques dans les 7 jours précédents
    3) Contre-indication à l’utilisation des corticoïdes systémiques : allergie aux corticoïdes, HTA sévère incontrôlée, diabète incontrôlé, ulcère gastro-intestinal hémorragique
    4) Pneumothorax à la randomisation
    5) Support circulatoire extra-corporel (ECMO or ECCO2R) à la randomisation
    6) Patient moribond
    7) Grossesse
    8) Patients protégés par la loi
    9) Période d’exclusion liée à une inclusion dans une autre étude pouvant influencer le critère principal de jugement
    10) Inclusion préalable dans cette étude
    E.5 End points
    E.5.1Primary end point(s)
    Number of ventilator-free days (VFD) and alive.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    - NIV failure rate, defined by intubation
    - Duration of NIV and of invasive mechanical ventilation
    - Circulatory and renal support-free days and alive at day 28
    - Severe hyperglycemia requiring intravenous insulin before day 5
    - Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation
    - Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)
    - ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge
    - ICU-acquired infections (especially Ventilator-Associated Pneumonia)
    - Length of ICU and hospital stay
    - ICU and hospital mortality
    - Day 28 and Day 90 mortality
    - Standardized mortality ratio (SMR)
    - Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
    - Dyspnea and comfort (patient reported outcome) at Day 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 5
    - Day 7
    - Day 28
    - Time of ICU discharge
    - Day 90 after discharge
    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 Yes
    E.6.4Safety No
    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 trial2
    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 concerned20
    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 Yes
    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
    Dernière visite dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    in case of intubation or severity of encephalopathy
    en cas d'intubation ou d’encéphalopathie hypercapnique
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state440
    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)
    Centers standard procedures
    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 Decision2019-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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