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    Summary
    EudraCT Number:2012-001771-36
    Sponsor's Protocol Code Number:OXAURP
    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:2012-06-25
    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 number2012-001771-36
    A.3Full title of the trial
    PILOT CLINICAL TRIAL, RANDOMIZED AND CONTROLLED OF THE USE-OF OXYGEN AT HIGH FLOW IN CHILDREN IN THE PEDIATRIC EMERGENCY SERVICE. COD: OXAURP
    ENSAYO CLÍNICO PILOTO, ALEATORIZADO, CONTROLADO DEL USO DE OXIGENOTERAPIA DE ALTO FLUJO EN CÁNULAS NASALES EN NIÑOS EN UN SERVICIO DE URGENCIAS DE PEDIATRÍA. COD: OXAURP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL: TREATMENT OF OXYGEN AT HIGH DOSES IN CHILDREN WITH ASTHMA CRISIS MODERATE / SEVERE IN THE EMERGENCY UNIT
    ENSAYO CLINICO: TRATAMIENTO DE OXIGENO A DOSIS ELEVADAS EN NIÑOS CON CRISIS ASMATICA MODERADA/ SEVERA EN EL SERVICIO DE URGENCIAS
    A.3.2Name or abbreviated title of the trial where available
    OXAURP
    OXAURP
    A.4.1Sponsor's protocol code numberOXAURP
    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 SponsorFRANCISCO JAVIER BENITO FERNANDEZ
    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 supportHOSPITAL UNIVERSITARIO CRUCES
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportDEPARTAMENTO DE SANIDAD GOBIERNO VASCO
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportMINISTERIO DE SANIDAD, SERVICIOS SOCIALES E IGUALDAD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL UNIVERSITARIO CRUCES
    B.5.2Functional name of contact pointUNIDAD DE INVESTIGACIÓN
    B.5.3 Address:
    B.5.3.1Street AddressPLAZA DE CRUCES S/N (Modulos detras de Pabellon de Administración)
    B.5.3.2Town/ cityBARAKALDO (BIZKAIA)
    B.5.3.3Post code48903
    B.5.3.4CountrySpain
    B.5.4Telephone number00349460060002368
    B.5.5Fax number0034946006451
    B.5.6E-mailana.irasarrisebastian@osakidetza.net
    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 OXIGENO MEDICINAL LIQUIDO EN RECIPIENTE CRIOGENICO FIJO
    D.2.1.1.2Name of the Marketing Authorisation holderPRAXAIR
    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 nameOXIGENO
    D.3.2Product code OXIGENO
    D.3.4Pharmaceutical form Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRespiratory use (Noncurrent)
    Inhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXIGENO
    D.3.9.1CAS number 7782-44-7
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number70 to 100
    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
    Objectives: To evaluate the feasibility and explore the efficacy, safety and tolerability of the administration of oxygen at high flow during the stay of these children in the Pediatric Emergency Department (PED) to prevent hospitalization
    Objetivos: evaluar la factibilidad y explorar la eficacia, seguridad y tolerancia de la administración de oxigenoterapia en alto flujo (OAF) durante la estancia de estos niños en el Servicio de Urgencias de Pediatría (SUP) para prevenir su hospitalización
    E.1.1.1Medical condition in easily understood language
    CLINICAL TRIAL OF STANDARD TREATMENT VS OXYGEN AT HIGH DOSES IN CHILDREN SUFFER FROM ACUTE ASTHMA IN PEDIATRICS EMERGENCY.
    ENSAYO CLINICO DE TRATAMIENTO HABITUAL FRENTE A OXIGENO A DOSIS ALTAS EN NIÑOS CON CRISIS ASMATICA EN EL SERVICIO DE URGENCIAS DE PEDIATRIA.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Assess the feasibility (adequacy and coordination of resources) from the OAF management in children with asthma and moderate to severe respiratory failure and / or high oxygen needs within a PED.
    Assess the efficacy of the OAF in the management of children with asthma and moderate to severe respiratory failure and / or high oxygen needs.
    Valorar la factibilidad (adecuación y coordinación de recursos) de la administración de OAF en niños con asma e insuficiencia respiratoria moderada-severa y/o necesidades elevadas de oxígeno en el seno de un SUP.
    Valorar la eficacia terapéutica de la administración de OAF en niños con asma e insuficiencia respiratoria moderada-severa y/o necesidades elevadas de oxígeno.
    E.2.2Secondary objectives of the trial
    Assess the safety and tolerance of the treatment given in this context.
    Assess organizational changes and adaptations to optimize the use of OAF if proved feasible.
    Valorar la seguridad y tolerancia del tratamiento administrado en este contexto.
    Evaluar posibles cambios y adaptaciones organizativas para optimizar el uso del OAF si se demuestra factible.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria: 1) Children admitted to the SUP, ages 1 and 14 years, 2) with acute asthma: any child with respiratory symptoms (cough, respiratory distress, tachypnea) attributed to bronchospasm (wheezing, expiratory elongated, hypoventilation , etc ...), regardless the possible trigger (infection, mites, pollens, etc ...) or the presence or absence of previous episodes.3) that meets at least one of the following criteria, moderate-severe respiratory failure (Pulmonary score ? 6) despite initial treatment with nebulized salbutamol every 20 minutes during the first hour (at least 3 doses): (Appendix 2). High O2 needs: O2 sat <90% with FiO2 40, detection by capnography (EtCO2) or blood gas pCO2> 45 mm Hg, 4) Parents and / or legal representatives agree to participate in the study.
    1)Niños ingresados en el SUP de edades entre 1 y 14 años,2)Con diagnóstico de crisis asmática: todo niño con síntomas respiratorios (tos, dificultad respiratoria, taquipnea) atribuidos a broncoespasmo (sibilancias, espiración alargada, hipoventilación, etc...), sin tener en cuenta el posible desencadenante (infección, ácaros, pólenes, etc...) ni la existencia o no de episodios previos.3) que cumpla al menos uno de los siguientes criterios, a pesar del tratamiento inicial con salbutamol nebulizado cada 20 minutos durante la primera hora (al menos, 3 dosis): Insuficiencia respiratoria moderada-grave (Pulmonary score ? 6) (anexo 2).Altas necesidades de O2: sat O2 < 90% con FiO2 40.Detección mediante capnografía (EtCO2) o gasometría de pCO2 > 45 mm de Hg.;4)Que sus padres y/o representantes legales acepten participar en el estudio.
    E.4Principal exclusion criteria
    Exclusion criteria: 1) Patients with other airway pathology that does not define as asthma.2) Patients with concomitant diseases that make advisable it´s admission.3) Patients requiring advanced air way stabilization.4) Any cultural, social problem, disease or problem of any kind that do assume the possible lack of cooperation from the patient and / or their legal representatives.
    1)Los pacientes con otra patología de la vía aérea que no definamos como asma.2)Pacientes con patologías concomitantes que hagan aconsejable su tratamiento hospitalario.3)Pacientes que requieran estabilización avanzada de la vía aérea.4)Cualquier problema de tipo cultural, social, enfermedad ó problema de cualquier tipo que haga presuponer la posible inexistencia de colaboración por parte del paciente y/o sus representantes legales
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility: professional initial acceptability and parents/tutor initial acceptability
    Efficacy : total failure and success of treatment
    Factibilidad:aceptabilidad inicial-profesional y aceptabilidad inicial-padres/tutores
    Eficacia: fracaso absoluto y exito de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 36 hours
    a las 36 horas
    E.5.2Secondary end point(s)
    Efficacy: Relative failure

    Security. proportion of day/stay in hospital. proportion of patients with improvement criteria

    Number of Salbutamol/hour doses
    Eficacia: fracaso Relativo

    Seguridad. Dias de estancia hospitalaria.Porcentaje de pacientes que cumplen criterios de mejoria.Numero de dosis de Salbutamol/hora
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 36 hours
    a las 36 horas
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    Factibilidad.
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    oxigeno a dosis estandar.
    oxygen at standard doses.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The end of the CT (for a patient) will be after 15 days of discharge.

    The end of the CT (in general) will be after 15 days of last patient recruited discharge.
    El EC por paciente finaliza a los 15 dias de producirse el alta hospitalaria.

    El fin del EC en general al de 15 dias de producirse el alta hospitalaria del ultimo paciente reclutado.
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 120
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    PEDIATRIC POPULATION
    POBLACION PEDIATRICA
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 0
    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)
    Continue with basal treatment for asthma
    Continuar con su tratamiento basal para el asma.
    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 Decision2012-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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