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    Summary
    EudraCT Number:2013-003619-24
    Sponsor's Protocol Code Number:bolpecocdpde
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-12-13
    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 number2013-003619-24
    A.3Full title of the trial
    Benefits of liquid oxygen in COPD patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion.
    Beneficios del oxígeno líquido en pacientes con EPOC, sin criterios de oxigenoterapia continua domiciliaria, que presentan desaturación al esfuerzo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benefits of liquid oxygen in chronic obstructive pulmonary disease (COPD) patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion.
    Beneficios del oxígeno líquido en pacientes con enfermedad pulmonar obstructiva crónica (EPOC), sin criterios de oxigenoterapia continua domiciliaria, que presentan desaturación al esfuerzo.
    A.4.1Sponsor's protocol code numberbolpecocdpde
    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 SponsorLourdes Lozano-Bailen
    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 supportSociedad Española de Neumología y Cirugía Torácica (SEPAR)
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportSocietat Catalana de Pneumologia (SOCAP)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrup ROV de la Societat Catalana de Pneumologia (SOCAP)
    B.5.2Functional name of contact pointMaria Rosa Güell-Rous
    B.5.3 Address:
    B.5.3.1Street AddressMas casanovas, 91
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.6E-mailmguellr@santpau.cat
    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 Oxígeno medicinal líquido Linde gas medicinal criogénico 99.5% V/V en recipiente criogénicos móviles, 1 recipiente criogénico móvil de 30l
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Medica S.L.U.
    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 nameLiquefied medicinal oxygen
    D.3.4Pharmaceutical form Medicinal gas, liquefied
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameliquefied medicinal oxygen
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit l litre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 6
    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 Yes
    D.3.11.13.1Other medicinal product typeLiquefied medicinal oxygen
    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
    Moderate to severe COPD patients: FEV1 <70%, FEV1/FVC <70%, TLC> 80% of the reference values (GesEPOC Stadium II-IV/GOLD III-IV)
    Pacientes diagnosticados de EPOC moderado-grave: FEV1 < 70%; FEV1/FVC < 70%, TLC> 80% de los valores de referencia (GesEPOC Estadio II-IV/GOLD III-IV)
    E.1.1.1Medical condition in easily understood language
    Patients with moderate to severe chronic obstructive pulmonary disease
    Pacientes diagnosticados de enfermedad pulmonar obstructiva crónica de moderada a grave
    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 analyze the benefits the adequate correction of oxygen desaturation during exercise in COPD patients without conventional criteria for LTOT in terms of the health related quality of life.
    Analizar los beneficios sobre la calidad de vida relacionada con la salud de la corrección adecuada de la desaturación al esfuerzo en pacientes con EPOC sin criterios convencionales de oxigenoterapia continua domiciliaria pero con desaturación al ejercicio.
    E.2.2Secondary objectives of the trial
    To analyze the improvement in dyspnea, exercise capacity, physical activity and adherence the treatment.
    Mejoría de la disnea, capacidad de esfuerzo, actividad física y cumplimiento del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients diagnosed with moderate - severe COPD (FEV1 <80%, FEV1/FVC <70%), total lung capacity (TLC)> 80% of the reference values (GesEPOC Stadium II-IV/GOLD III-IV)
    - Do not meet conventional criteria for Long term oxygen therapy (LTOT) indication (SEPAR Guides and GOLD)
    - Stability clinic in the last month
    - Optimized medical treatment
    - SpO2 mean ? 88% in the six minute walking test (6MWT)
    - Active life
    -Pacientes diagnosticados de EPOC moderado ? grave (FEV1 < 80%; FEV1/FVC < 70%) capacidad pulmonar total (TLC) > 80% de los valores de referencia (GesEPOC Estadio II-IV/GOLD III-IV)
    -Que no cumplan criterios convencionales de indicación de OCD (Guías SEPAR y GOLD)
    -Estabilidad clínica en el último mes
    -Tratamiento médico optimizado
    -SpO2 media ? 88% en la P6MM
    -Vida activa fuera del domicilio
    E.4Principal exclusion criteria
    - Current smokers
    - Respiratory failure with criteria for LTOT (PaO2 <55 mmHg or 55-60 mmHg associated with pulmonary hypertension, cor pulmonale, congestive heart failure, arrhythmias or polycythemia).
    - Impaired mobility
    - Cognitive impairment or intellectual disability
    - Disagreement to use liquid oxygen out of home
    - Severe comorbidities
    - Participation in pulmonary rehabilitation program
    -Fumadores activos
    -Presencia de insuficiencia respiratoria y criterios para OCD (PaO2<55 mmHg o entre 55-60 mmHg asociada a hipertensión arterial pulmonar, cor pulmonale crónico, insuficiencia cardíaca congestiva, arritmias ó poliglobulia).
    -Presencia de alteración de la movilidad que le suponga un problema para la deambulación
    -Deterioro cognitivo o incapacidad intelectual que le impida rellenar cuestionarios
    -No aceptación del oxígeno líquido
    -Presencia de enfermedades graves activas
    -Participación en programas de rehabilitación respiratoria
    E.5 End points
    E.5.1Primary end point(s)
    Health releated quality of live (HRQOL): increase of 0.5 points or more per domain in the CRQ questionnaire and/or improvement in 2 or more points in the CAT questionnaire were considered as the minimal importance difference.
    Calidad de vida relacionada con la salud (CVRS): se considerará como mejoría un incremento de al menos 0,5 en al menos, una de las cuatro áreas del cuestionario CRQ y una mejoría de 2 o más puntos en el COPD assesment test (CAT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    E.5.2Secondary end point(s)
    1. ? Dyspnoea improvement measured by MRC scale.
    2.- Increase at least 27 meters of the distance of the 6 minutes walking test.
    3. ? Increase of the physical activity measured by accelerometer.
    4. - Adherence. Hours using oxygen (Visionox ® device).
    1.- Mejoría en la disnea medida por la escala MRC.
    2.-Mejoría en la capacidad de esfuerzo: considerando como diferencia clínicamente significativa el incremento de, al menos, 26 metros en la distancia recorrida en la prueba de 6 minutos de la marcha.
    3.- Actividad física medida con el acelerómetro.
    4.- Cumplimiento. Se analizará contabilizando las horas de uso reportadas por el paciente, a través del total de oxígeno consumido en un tiempo determinado que se obtendrá de las empresas suministradoras, y de la utilización del dispositivo VisionOx®.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    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 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) 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    Oxígeno líquido medicinal a diferentes flujos
    Liquefied medicinal oxygen at different flows
    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 concerned5
    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
    Last visit of the last patient or after three years of the trial beginning.
    Última visita del último paciente o a los tres años del inicio del reclutamiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state112
    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)
    Patients will follow the usual care in their hospital.
    Los pacientes seguirán los controles por su neumólogo habitual.
    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 Decision2014-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-01
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