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    Summary
    EudraCT Number:2017-000895-27
    Sponsor's Protocol Code Number:IIBSP-OXI-2017-18
    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:2017-03-31
    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 number2017-000895-27
    A.3Full title of the trial
    Can high-flow oxygen optimize the benefits of Pulmonary Rehabilitation in patients with Diffuse Interstitial LungDisease (ILD) with oxygen desaturation during effort?
    ¿Puede el oxígeno de alto flujo optimizar los beneficios de la Rehabilitación Respiratoria en enfermos con Enfermedad Pulmonar Intersticial Difusa (EPID) que desaturan al esfuerzo?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can high-flow oxygen optimize the benefits of Pulmonary Rehabilitation in patients with Diffuse Interstitial LungDisease (ILD) with oxygen desaturation during effort?
    ¿Puede el oxígeno de alto flujo optimizar los beneficios de la Rehabilitación Respiratoria en enfermos con Enfermedad Pulmonar Intersticial Difusa (EPID) que desaturan al esfuerzo?
    A.4.1Sponsor's protocol code numberIIBSP-OXI-2017-18
    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 SponsorInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    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 de Recerca Hospital de la Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537636
    B.5.5Fax number34935537812
    B.5.6E-mailepenag@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 Conoxia
    D.2.1.1.2Name of the Marketing Authorisation holderLinde
    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 nameOxigen
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    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.3.9.1CAS number 7782-44-7
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number95
    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
    Diffuse Interstitial LungDisease (ILD)
    Enfermedad pulmonar intersticial difusa (EPID)
    E.1.1.1Medical condition in easily understood language
    Diffuse Interstitial LungDisease (ILD)
    Enfermedad pulmonar intersticial difusa (EPID)
    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 compare the level of oxygenation achieved during muscle training with conventional oxygen (nasal goggles) and high flow systems.
    Comparar el nivel de oxigenación logrado durante el entrenamiento muscular con sistemas de oxigenoterapia convencional (gafas nasales) y de alto flujo.
    E.2.2Secondary objectives of the trial
    To compare the benefits achieved with the two oxygen therapy systems in terms of:

    - Level of effort achieved during training
    - Post-effort tolerance with 6mwt
    - Improvement in dyspnea
    - Improvement in Health-Related Quality of Life
    Comparar los beneficios logrados con los dos sistemas de oxigenoterapia, en términos de:

    - Nivel de esfuerzo logrado durante el entrenamiento
    - Tolerancia posterior al esfuerzo con la P6MM
    - Mejoría en la disnea
    - Mejoría en la Calidad de Vida Relacionada con la Salud
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age> 30 years
    - Diagnosis of EPID according to national and international regulations
    - Sign the informed consent
    - Edad> 30 años
    - Diagnóstico de EPID según las normativas nacionales e internacionales
    - Firmar el consentimiento informado
    E.4Principal exclusion criteria
    - Have performed a RR program (including training) in the last 6 months
    - Respiratory diseases other than DID (cardiac, neuromuscular, anemia and vascular) or important comorbidities
    - Osteoarticular diseases that make it difficult to perform exercise
    - End-stage disease (inability to perform exercises or treatment with morphs)
    - Life expectancy <6 months
    - Cognitive disorders that difficult active participation
    - Haber realizado un programa de RR (que incluya entrenamiento) en los últimos 6 meses
    - Enfermedades respiratorias diferentes de la EPID (cardíacas, neuromusculares, anemia y vasculares) o comorbilidades importantes
    - Enfermedades osteoarticulares que dificulten la realización de ejercicio
    - Enfermedad en fase terminal (incapacidad para realizar los ejercicios o bien tratamiento con mórficos)
    - Pronóstico de vida < 6 meses
    - Trastornos cognitivos que impidan participar activamente
    E.5 End points
    E.5.1Primary end point(s)
    The average oxyhemoglobin saturation (SpO2) achieved throughout the training period comparing that of both groups.
    La Saturación de oxihemoglobina (SpO2) media lograda durante todo el periodo de entrenamiento comparando la de ambos grupos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    E.5.2Secondary end point(s)
    - Dyspnea on exertion before and after P6MM (Borg scale)
    - Capacity of effort measured by the P6MM
    - HRQL using questionnaires Questionnaire KBILD and SF36
    - Adverse effects of the program
    - Compliance with the program
    - Disnea al esfuerzo antes y después de la P6MM (escala de Borg)
    - Capacidad de esfuerzo medida por la P6MM
    - CVRS mediante los cuestionarios Cuestionario KBILD y SF36
    - Efectos adversos del programa
    - Cumplimiento del programa
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 semanas
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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
    Última visita del último sujeto
    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 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: 60
    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 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 state60
    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)
    Expected normal treatment of the condition
    Tratamiento habitual de la patología en estudio
    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 Decision2017-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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