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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-006427-18
    Sponsor's Protocol Code Number:2021.143
    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:2022-08-05
    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 number2021-006427-18
    A.3Full title of the trial
    M-POC-O2: high flow nasal cannula oxygen versus conventional oxygen therapy in exacerbated chronic obstructive pulmonary disease (COPD) patients without respiratory acidosis. Pilot Study.
    M-POC-O2: terapia de oxígeno con alto flujo administrada con cánulas nasales versus oxígeno convencional en pacientes con enfermedad pulmonar obstructiva crónica agudizada sin acidosis respiratoria. Estudio Piloto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study that aims to compare the use of administered oxygen with the usual techniques versus the administration of oxygen with a different technique, is called high flow, in patients who have chronic respiratory problems and have a worsening.
    Estudio que pretende comparar el uso de oxígeno administrado con las técnicas de siempre versus la administración de oxígeno con una técnica diferente, llamada alto flujo, en los pacientes que tienen problemas respiratorios crónicos y presentan un empeoramiento.
    A.3.2Name or abbreviated title of the trial where available
    M-POC-O2: high flow oxygen versus conventional oxygen therapy in COPD patients.
    M-POC-O2: oxígeno a alto flujo versus oxigenoterapia convencional en pacientes con EPOC.
    A.4.1Sponsor's protocol code number2021.143
    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 SponsorAnna Coquard Rafales
    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 supportInstitut d'Assistència Sanitaria - Hospital Santa Caterina
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnna Coquard Rafales
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDr Castany
    B.5.3.2Town/ citySalt
    B.5.3.3Post code17190
    B.5.3.4CountrySpain
    B.5.4Telephone number+349721826001356
    B.5.5Fax number+34972182605
    B.5.6E-mailanna.coquard@ias.cat
    D. IMP Identification
    D.IMP: 1
    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 Airvo2 Humidification System
    D.2.1.1.2Name of the Marketing Authorisation holderFisher & Payke Healthcare
    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 nameoxygen
    D.3.2Product code 12
    D.3.4Pharmaceutical form Medicinal gas, liquefied
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    Intranasal use (Noncurrent)
    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
    Patients older than 35 years old with COPD diagnosis (chronic obstructive pulmonary disease) by spirometry, presenting acute exacerbation without respiratory acidosis.
    Pacientes mayores de 35 años con diagnóstico de enfermedad pulmonar obstructiva crónica (EPOC) diagnóstico por espirometria, que presenta agudización aguda sin acidosis respiratoria.
    E.1.1.1Medical condition in easily understood language
    Patients older than 35 years with chronic lung disease with acute worsening
    Pacientes mayores de 35 años con enfermedad pulmonar crónica que presenta un empeoramiento agudo.
    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
    Demonstrate that High Flow Nasal Cannula Therapy (HFNCT), with a minimal flow of 40L/min, in COPD exacerbated patients, without respiratory acidosis, seen at Emergency Service, reduces dyspnea, respiratory frecuency (RF) and
    breathing work without producing, at the same time, an increase of carbon dioxide arterial blood pressure (PaCO2) during the first 24 hours, in respect to Convencional Oxygen Therapy (OCT).
    Demostrar que la Terapia con Cánula Nasal de Alto Flujo (TAFCN), con un flujo mínimo de 40L/min, en pacientes EPOC exacerbados, sin acidosis respiratoria, atendidos en el Servicio de Urgencias, reduce la disnea, la frecuencia respiratoria (FR) y el
    trabajo respiratorio sin producir, al mismo tiempo, un aumento de la presión arterial de dióxido de carbono (PaCO2) durante las primeras 24 horas, respecto a la Oxigenoterapia Convencional (OTC).
    E.2.2Secondary objectives of the trial
    - To demonstrate that HFNCT, with a minimal flow of 40L/min, in exacerbated COPD patients without respiratory acidosis seen at Emergency Service, reduces dyspnea, RF and
    breathing work, without simultaneously producing an increase of PaCO2 in the first 3 days of admission in comparison to COT.
    - To demonstrate that HFNCT, with a minimal flow of 40L/min, in exacerbated COPD patients without respiratory acidosis seen at Emergency Service, reduces hospitalization days, mortality at 30 and 60 days, risk for poor evolution and number of annual exacerbations in comparison to COT.
    - To demonstrate that HFNC, with a minimal flow of 40L/min, in patients with acute COPD
    without respiratory acidosis seen at Emergency Service, decreases PaCO2 at 6 and 12 months in comparison to COT.
    - Demostrar que la TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC agudizada, sin acidosis respiratoria, atendidos en Urgencias, reduce la disnea, la FR y eltrabajo respiratorio, sin que se produzca simultáneamente un aumento de la PaCO2 en los 3 primeros días de ingreso respecto al OTC.
    - Demostrar que la TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC agudizada sin acidosis respiratoria atendidos en Urgencias, reduce los días de hospitalización, la mortalidad a los 30 y 60 días, el riesgo de mala evolución y el número de agudizaciones anuales en comparación con OTC.
    - Demostrar que la TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC aguda, sin acidosis respiratoria, atendido en Urgencias, disminuye PaCO2 a los 6 y 12 meses respecto al OTC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient older than 35 years old.
    - Patients with COPD diagnosis by spirometry.
    - Patients presenting acute exacerbation without respiratory acidosis.
    - Paciente mayor de 35 años.
    - Pacientes con diagnóstico de EPOC por espirometría.
    - Pacientes que presenten exacerbación aguda sin acidosis respiratoria.
    E.4Principal exclusion criteria
    - NT-ProBNP (N terminal – Pro B type natriuretic peptide) with highly probable heart failure result.
    - Positive SARS-CoV-2 PCR in the last 15 days.
    - Arterial blood gases (ABG) with respiratory acidosis (pH<7.35).
    - Lack of tolerability to oxygen administration at flow ≥ 40L/min.
    - Clinical manifestation of serious hypercapnic encephalopathy (HE) (Glasgow Coma Scale (GCS) < 10).
    - Onset of Non invasive ventilation (NIV) upon Emergency Service arrival.
    - Carriers of NIV/CPAP (continuous positive airway pressure) at home.
    - NT-ProBNP (N terminal – Pro péptido natriurético tipo B) con resultado altamente probable de insuficiencia cardiaca.
    - SARS-CoV-2 PCR positivo en los últimos 15 días.
    - Gasometría arterial (GSA) con acidosis respiratoria (pH<7,35).
    - Falta de tolerabilidad a la administración de oxígeno a flujo ≥ 40L/min.
    - Manifestación clínica de encefalopatía hipercápnica grave (EH) (Escala de Coma de Glasgow (GCS) < 10).
    - Inicio de Ventilación no Invasiva (VNI) a la llegada del Servicio de Urgencias.
    - Portadores de VNI/CPAP (presión positiva continua de las vías respiratorias) a domicilio.
    E.5 End points
    E.5.1Primary end point(s)
    Oxygen administration with HFNCT, with a minimal flow of 40L/min, in patients with acute COPD without respiratory acidosis seen at Emergency Service, decreases dyspnea, RF and breathing work, without simultaneously producing an increase of PaCO2 in the first 24 hours in comparison to COT.
    La administración de oxígeno con TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC aguda sin acidosis respiratoria atendidos en Urgencias, disminuye la disnea, la FR y el trabajo respiratorio, sin producir simultáneamente un aumento de la PaCO2 en las primeras 24 horas respecto a OTC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of this hypothesis at the end of the study
    Evaluación de esta hipótesis al final del estudio
    E.5.2Secondary end point(s)
    - Oxygen administration with HFNCT, with a minimal flow of 40L/min, in patients with acute COPD without respiratory acidosis seen at Emergency Service, decreases dyspnea, RF and breathing work, without simultaneously producing a significant increase of PaCO2 after 3 days of admission in comparison with COT.
    - Oxygen administration at with HFNCT, with a minimal flow of 40L/min, in patients with acute COPD without respiratory acidosis seen at Emergency Service, decreases the hospitalization days, mortality at 30 and 60 days, risk for poor evolution and number annual of exacerbations in comparison to COT.
    - Oxygen administration at HFNCT, with a minimal flow of 40L/min, in patients with acute COPD without respiratory acidosis seen at Emergency Service, decreases PaCO2 at 6 and 12 months in comparison to COT.
    - La administración de oxígeno con TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC aguda sin acidosis respiratoria atendidos en Urgencias, disminuye la disnea, la FR y el trabajo respiratorio, sin producir simultáneamente un aumento significativo de la PaCO2 tras 3 días de ingreso en comparación con OTC.
    - La administración de oxígeno con TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC aguda sin acidosis respiratoria atendidos en Urgencias, disminuye los días de hospitalización, la mortalidad a los 30 y 60 días, el riesgo de mala evolución y el número anual de agudizaciones en comparación con OTC.
    - La administración de oxígeno en TAFCN, con un flujo mínimo de 40L/min, en pacientes con EPOC aguda sin acidosis respiratoria atendidos en Urgencias, disminuye la PaCO2 a los 6 y 12 meses respecto al OTC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of these secondary hypotheses at the end of the study
    Evaluación de estas hipótesis secundarias al final del estudio
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) 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 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
    LVLS
    La última visita del último sujeto
    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 months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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
    Ninguna
    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 Decision2022-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-16
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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