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    Summary
    EudraCT Number:2012-000775-17
    Sponsor's Protocol Code Number:PI11-0143
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000775-17
    A.3Full title of the trial
    A comparative, randomised controlled trial for evaluating the efficacy of dexamethasone administration in the treatment of patients with the Acute Respiratory Distress Syndrome
    Ensayo clínico comparativo, aleatorio, controlado para evaluar la eficacia de la administración de dexametasona en el tratamiento de pacientes con Síndrome de Distrés Respiratorio Agudo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparative, randomised controlled trial for evaluating the efficacy of dexamethasone administration in the treatment of patients with the Acute Respiratory Distress Syndrome
    Ensayo clínico comparativo, aleatorio, controlado para evaluar la eficacia de la administración de dexametasona en el tratamiento de pacientes con Síndrome de Distrés Respiratorio Agudo
    A.4.1Sponsor's protocol code numberPI11-0143
    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 SponsorJesús Villar Hernández
    B.1.3.4CountrySpain
    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 supportFundación Mutua Madrileña
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación. Hosp Univ de GC Dr. Negrín
    B.5.2Functional name of contact pointRosa Lidia Fernández
    B.5.3 Address:
    B.5.3.1Street AddressBco de la Ballena s/n
    B.5.3.2Town/ cityLas Palmas de Gran Canaria
    B.5.3.3Post code35010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34928450082
    B.5.5Fax number+34928449813
    B.5.6E-mailrosalidia.fernandez@gmail.com
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameDexametasona
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.9.1CAS number 50-02-2
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute respiratory distress syndrome (ARDS)
    Síndrome de Distrés Respiratorio agudo
    E.1.1.1Medical condition in easily understood language
    Acute respiratory distress syndrome (ARDS)
    Síndrome de insuficiencia respiratoria aguda
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of dexamethasone in increasing by the number of ventilator-free days days (VFDs) at 28 days
    Evaluar la eficacia de la dexametasona en la duración de la ventilación mecánica (medida como nº de días libres de ventilación mecánica en 28 días.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of dexamethasone in reducing overall mortality.
    Evaluar la eficacia de la dexametasona en reducir la mortalidad global.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion into this study (Day 0), each patient must fulfil the following inclusion criteria during screening and prior to the enrolment into the study:

    a. Age >=18 years old
    b. Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS:
    i. Having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.).
    ii. bilateral infiltrates on frontal chest radiograph
    iii. absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure
    iv. severe hypoxemia (a PaO2/FIO2 <=200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
    c. Be intubated and mechanically ventilated
    d. Have provided signed written informed consent from the patient or the patient's personal legal representative.
    Para ser elegible para inclusión en el estudio (Día 0), cada paciente debe cumplir los siguientes criterios de inclusión durante el screening y antes de considerarlo incluido:
    a. Edad >=18 años
    b. Pacientes deben tener un episodio agudo de ARDS, definido según los criterios de ARDS de la Conferencia de Consenso Americana-Europea (AECC):
    i. Tener una causa clínica del ARDS (neumonía, sepsis, traumatismo,
    aspiración, inhalación de tóxico, politransfusión, post-operado de trasplante
    de órganos o enfermedades neoplásicas, pancreatitis aguda, etc.).
    ii. Infiltrados pulmonares bilaterales en la radiografía de tórax
    iii. Ausencia de hipertensión auricular izquierda, presión capilar pulmonar <18 mmHg, o ausencia de signos de fracaso ventricular izquierdo.
    iv. Hipoxemia grave (una PaO2/FiO2 <=200 mmHg, independientemente de la FiO2 y del nivel de PEEP.
    c. Estar intubado y ventilado mecánicamente.
    d. Haber obtenido el consentimiento informado del paciente o de su representante legal.
    E.4Principal exclusion criteria
    To be eligible for inclusion into this study (Day 0), each patient must not have any of the following exclusion criteria during screening and prior to the enrolment into the study:

    e. Be a woman known to be pregnant or lactating
    f. Take part in another experimental treatment protocol (simultaneously)
    g. Brain death
    h. Terminal-stage cancer or other terminal disease
    i. Having do-not-resuscitate orders
    j. Being immune-compromised
    k. Receiving corticosteroids or immunosuppressive drugs
    l. Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
    m. Have severe chronic obstructive pulmonary disease (COPD)
    n. Have congestive heart failure
    Para ser elegible de ser incluido en este estudio (Día 0), cada paciente no debe tener ninguno de los
    siguientes criterios de exclusión durante el screening y antes de ser incluido en el estudio:
    a. Mujer embarazada o en periodo de lactancia
    b. Tomar parte simultáneamente en otro protocolo terapéutico experimental
    c. Muerte cerebral
    d. Cáncer en fase terminal o cualquier otra enfermedad terminal.
    e. Tener órdenes de "no resucitar"
    f. Estar bajo tratamiento previo con corticoides o inmunosupresores.
    g. Pacientes en los que han pasado más de 24 horas desde que cumplieron los criterios de
    ARDS antes de obtener el consentimiento informado y se mida la PaO2/FiO2 en condiciones
    estándar.
    h. Tener enfermedad pulmonar obstructiva crónica
    i. Tener insuficiencia cardiaca congestiva
    E.5 End points
    E.5.1Primary end point(s)
    Number of ventilator free-days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated >=28 days and for subjects who die, VFD is 0.
    Número de días libres de ventilación mecánica (VFDs) a Día 28 (definido como los días en que el paciente está vivo y libre de la ventilación mecánica dentro de los 28 días después de la intubación). Para pacientes ventilados >=28 días o que fallecen, el valor de VFD es 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days after discharge
    A 60 días del alta
    E.5.2Secondary end point(s)
    -All-cause mortality at Day 60 after enrolment.
    -Mortality at ICU and hospital discharge
    -Duration (in days) on mechanical ventilation
    -Number of extra-pulmonary organ failures (we will consider central nervous system, heart, kidney, gastrointestinal, liver, coagulation, and shock).
    -Mortalidad por cualquier causa a los 60 días de la inclusión en el estudio
    -Mortalidad en la Unidad de Medicina Crítica y al alta hospitalaria.
    -Duración (días) de la ventilación mecánica
    -Nº de órganos y sistemas extra-pulmonares que fracasan (sistema nervioso central, corazón, riñón, gastrointestinal, hígado, coagulación, shock).
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days after discharge
    A 60 días del alta
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento convencional pero sin dexametasona
    Normal treatment but without dexamethasone
    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 concerned23
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 264
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 state314
    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)
    Not different form the expected normal treatment of that condition
    No diferirá del tratamiento normal de esta enfermedad
    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 Decision2012-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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