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    Summary
    EudraCT Number:2016-000497-38
    Sponsor's Protocol Code Number:DEX-PCH-VMNI
    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:2016-02-23
    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 number2016-000497-38
    A.3Full title of the trial
    Dexmedetomidine versus current clinical practice for non-invasive mechanical ventilation: a randomized clinical trial
    Dexmedetomidina versus practica clínica habitual durante la ventilación mecánica no invasiva: Ensayo clinico aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dexmedetomidine versus current clinical practice for non-invasive mechanical ventilation: a randomized clinical trial
    Dexmedetomidina versus practica clínica habitual durante la ventilación mecánica no invasiva: Ensayo clinico aleatorizado
    A.3.2Name or abbreviated title of the trial where available
    DEX-PCH-VMNI
    A.4.1Sponsor's protocol code numberDEX-PCH-VMNI
    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 SponsorAna Vallejo De la Cueva
    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 supportBasque Health System
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAraba University Hospital
    B.5.2Functional name of contact pointAna Vallejo
    B.5.3 Address:
    B.5.3.1Street AddressOlaguibel 25
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01004
    B.5.3.4CountrySpain
    B.5.6E-mailANA.VALLEJODELACUEVA@osakidetza.eus
    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 DEXDOR
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    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.3.4Pharmaceutical form 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 PROPOFOL MIDAZOLAM MORPHINE PHENTANYL
    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.3.4Pharmaceutical form 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Accute respiratory insuffienciency
    Insuficiencia respiratoria aguda
    E.1.1.1Medical condition in easily understood language
    Accute respiratory insuffienciency
    Insuficiencia respiratoria aguda
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    Analyze percentage of patients on dexmedetomidine for NIMV needing intubation compared to percentage of patients ongoing current clinical practice (CCP) needing intubation.
    Analizar el porcentaje de pacientes con VMNI que recibieron dexmetomidina que requieren intubación frente a los que se les aplico la práctica clínica habitual (PCH).
    E.2.2Secondary objectives of the trial
    - Length (in hours) of NIMV for both groups.
    - ICU length of stay (in days) for both groups.
    - Hospital length of stay (in days) for both groups.
    - To compare global ICU mortality in both groups.
    - To compare respiratory failure related ICU mortality.
    - To analyze Global inhospital mortality.
    - To analyze Respiratory failure related inhospital mortality.
    - To describe ARF evolution in both groups.
    - To describe tolerance to NIMV along dexmedetomidine VS CCP administration.
    - To describe adverse effects related to dexmedetomidine administration.
    - Satisfaction survey for dexmedetomidine VS CCP.
    ? Determinar la duración de la VMNI (horas) en cada grupo.
    ? Analizar la estancia en UCI (días) en cada grupo.
    ? Analizar la estancia hospitalaria (días) en cada grupo.
    ? Comparar la mortalidad en UCI por cualquier causa entre ambos grupos.
    ? Comparar la mortalidad en UCI por IRA entre ambos grupos
    ? Analizar la mortalidad hospitalaria por cualquier causa.
    ? Analizar la mortalidad hospitalaria asociada a IRA
    ? Describir la evolución de la IRA en cada grupo.
    ? Describir la tolerancia a la VMNI durante la administración de la dexmedetomidina versus PCH.
    ? Describir los efectos adversos derivados de la administración de la dexmedetomidina.
    ? Valorar el grado de satisfacción del paciente dexmedetomidina versus PCH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (over 18 years)

    - Reversible ARF secondary to cardiac failure, COPD exacerbation, pneumonia, post-extubation failure, fulfilling criteria for NIMV.
    >Respiratory distress signs or symptoms:
    Mild to severe dyspnea and/or
    Respiratory rate over 25 in COPD patients, over 30 in hypoxic patients and/or
    Accessory muscles use and/or paradoxical breathing.
    Hypercapnic encephalopathy
    >Gas exchange disturbances
    PaC02>45mmHg, pH<7,35 and/or
    Pa02/Fi02 between 300 and 150.
    - Mayores de 18 años con:
    - IRA reversible secundaria a fallo cardíaco, exacerbación de EPOC, neumonía, o con riesgo de fracaso postextubación, que cumplan criterios de inicio de VMNI.
    >Signos y síntomas de distress respiratorio
    Disnea moderada o severa, incrementada sobre la habitual y/ó
    Frecuencia respiratoria mayor de 25 en EPOC, o mayor de 30 en IRA hipoxémica y/ó.
    Utilización de musculatura accesoria y/o respiración paradójica y/ó.
    Encefalopatía hipercapnica
    >Y alteraciones del intercambio gaseoso
    PaC02>45mmHg, pH<7,35 y/ó
    Pa02/Fi02 entre 300 y 150.
    E.4Principal exclusion criteria
    - CPR, need of intubation and mechanical ventilation.
    - Severe comorbidity ( myocardial ischemia, hypotension, arrhythmias)
    - Chronic obstruction of superior airway.
    - Tracheostomy.
    - Non-drained Neumothorax .
    - Severe agitation after drug administration.
    - Burns or facial trauma.
    - Facial surgery or facial abnormalities.
    - Hypersensibility or allergy to any drug in the study.
    - Egg, soya bean or peanut allergy.
    - HR less than 50 bpm non ?-blocker induced.
    - 2nd or 3rd grade AVB without pacemaker.
    - Cerebro-vascular severe injury.
    - Intracranial hypertension.
    - Glaucoma.
    - Miastenia gravis.
    - Concomitant use of inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir).
    - Pregnant women or breast-feeding period.
    - Refusal to enter the study.
    ? Parada respiratoria, indicación directa de IOT y VMI.
    ? Comorbilidad severa inestable (isquemia miocárdica, hipotensión, arritmias).
    ? Incapacidad para proteger la vía aérea: broncoaspiración.
    ? Obstrucción fija de la vía aérea superior.
    ? Traqueostomía.
    ? Neumotórax no drenado.
    ? Agitación intensa o falta e colaboración del paciente a pesar de la medicación administrada.
    ? Quemaduras o traumatismos faciales.
    ? Cirugía o alteraciones anatómicas faciales que impidan ajustar la mascarilla.
    ? Alergia o hipersensibilidad a cualquiera de los fármacos del estudio
    ? Alergia al huevo, a la soja, o al cacahuete.
    ? FC < 50lpm no inducido por ?-bloqueantes.
    ? BAV 2º-3º grado sin marcapasos.
    ? Enfermedad cerebro-vascular grave
    ? Aumento de la presio?n intracraneal.
    ? Glaucoma de angulo cerrado
    ? Miastenia Gravis
    ? Uso concurrente de inhibidores de CYP3A4 (amprenavir, atazanavir, or ritonavir)
    ? Negativa a participar en el estudio.
    ? Pacientes embarazadas o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Need of intubation: presence or any of these items.
    - Sp02<80% or PaO2/FiO2 < 150.
    - Seizures.
    - Secretions.
    - Hypercapnia and pH < 7.20.
    - Hypotension. SBP > 800 mmHg after vasoactive drugs.
    - Ischemic changes or ventricular arrhythmias on EKG related to myocardial hypoxia.
    - Necesidad de intubación se define como la presencia de cualquiera de estos items:
    ? Sp02<80% o PaO2/FiO2 < 150.
    ? Crisis convulsivas.
    ? Mal manejo de las secreciones.
    ? Hipercapnia y pH < 7.20.
    ? Hipotension: presión arterial sistólica (PAS) <80mmHg refractaria a pesar de la administración de aminas vasoactivas.
    ? Electrocardiograma (ECG) con cambios isquémicos o arritmias ventriculares por existencia de hipoxia miocardica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of NIMV
    Finalización de la VMNI
    E.5.2Secondary end point(s)
    ? Duration of NIMV (in hours).
    ? ICU stay (days).
    ? Hospital stay (days).
    ? Global ICU mortality.
    ? Specific ICU mortality.
    ? Global inhospital mortality.
    ? Respiratory failure related inhospital mortality.
    ? ARF evolution in both groups.
    ? Tolerance to NIMV
    ? Adverse effect.
    ? Satisfaction survey.
    ? Duración de la VMNI: Número de horas que el el paciente estará sometido a técnicas de VMNI.
    ? Estancia en UCI: Número de días que el enfermo estará ingresado en la UCI, hasta el alta a planta o fallecimiento.
    ? Estancia hospitalaria : Número de días que el enfermo estará ingresado en el hospital, hasta el alta al domicilio o fallecimiento.
    ? Mortalidad total en UCI
    ? Mortalidad especifica en UCI
    ? Mortalidad especifíca hospitalaria
    ? Mortalidad total hospitalaria:
    ? evolución de la IRA:
    ? tolerancia a la VMNI
    ? efectos adversos
    ? Grado de satisfacción del paciente
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of NIMV or ICU stay or Hospital stay
    Finalización de VMNI ó estancia en UCI ó estancia hospitalaria
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned3
    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
    UVUP
    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 months0
    E.8.9.1In the Member State concerned 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    UNCONSCIOUS
    INCONSCIENTES
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state198
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 198
    F.4.2.2In the whole clinical trial 198
    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
    Ninguno
    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 Decision2016-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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