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    Summary
    EudraCT Number:2020-005319-33
    Sponsor's Protocol Code Number:BuS2020
    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:2021-03-11
    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 number2020-005319-33
    A.3Full title of the trial
    EFFICACY AND SAFETY OF THE INTRATRACHEAL ADMINISTRATION OF BUDESONIDE WITH SURFACTANT IN VERY PRETERM INFANTS TO PREVENT BRONCHOPULMONARY DYSPLASIA: RANDOMIZED CLINICAL TRIAL
    EFICACIA Y SEGURIDAD DE LA ADMINISTRACIÓN DE BUDESONIDA CON SURFACTANTE INTRATRAQUEAL EN LA PREVENCIÓN DE DISPLASIA BRONCOPULMONAR DEL RECIÉN NACIDO MUY PREMATURO: ENSAYO CLÍNICO ALEATORIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY OF THE INTRATRACHEAL ADMINISTRATION OF BUDESONIDE WITH SURFACTANT TO PREVENT CHRONIC LUNG DISEASE IN PREMATURE BABIES
    EFICACIA Y SEGURIDAD DE LA ADMINISTRACIÓN DE BUDESONIDA CON SURFACTANTE PARA LA PREVENCIÓN DE LA ENFERMEDAD CRÓNICA PULMONAR DEL PREMATURO.
    A.4.1Sponsor's protocol code numberBuS2020
    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 SponsorFundación Cínic per a la Reserca Biomèdica
    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 supportFundación Cínic per a la Reserca Biomèdica
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinic BCNatal
    B.5.2Functional name of contact pointSecretaría Neonatología
    B.5.3 Address:
    B.5.3.1Street AddressSabino Arana
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number003493227 56 007447
    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 Budesonida Aldo-Unión 0,50 mg/ml suspensión para inhalación por nebulizador.
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorio Aldo-Unión S.L.
    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 Nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntratracheal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEndotracheopulmonary instillation, suspension
    D.8.4Route of administration of the placeboEndotracheopulmonary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bronchopulmonary dysplasia of prematurity
    Displasia broncopulmonar de la prematuridad
    E.1.1.1Medical condition in easily understood language
    Chronic lung disease of the prematurity
    Enfermedad pulmonar crónica del prematuro
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) of patients who received intratracheal budesonide with surfactant, with those who only received intratracheal surfactant at 7 days of life.
    Comparar marcadores ecográficos (score de aireación) y biológicos (concentración de IL-6 en secreciones respiratorias) a los 7 días de vida de los pacientes que han recibido budesonida con surfactante y de los que han recibido sólo surfactante
    E.2.2Secondary objectives of the trial
    1- To compare the lung ultrasound score of both groups at 28 days of life.
    2- To compare IL-6 concentration in respiratory secretions of both groups at 28 days of life.
    3- To compare number of days on oxygen and respiratory support of both groups.
    4- To compare the incidence of bronchopulmonary dysplasia of both groups.
    5- To evaluate possible side effects of the intratracheal administration with surfactant in very preterm infants.
    6- To evaluate the respiratory status and neurodevelopment of both groups at 2 years of age.
    1- Comparar el score de aireación (SA) durante el primer mes en ambos grupos.
    2- Comparar la concentración de IL-6 en secreciones respiratorias a los 28 días de vida en ambos grupos.
    3- Comparar los días de oxígeno y el soporte respiratorio en ambos grupos.
    4- Comparar incidencia de displasia broncopulmonar en ambos grupos.
    5- Evaluar posibles efectos adversos de la administración de budesonida y surfactante intratraqueal en el paciente muy prematuros.
    6- Evaluar el estatus respiratorio y neurodesarrollo a los dos años de vida en ambos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Infants born earlier than 32 weeks of gestational age admitted in the Neonatal Intensive Care Unit.
    - Clinical decision to administer intratracheal surfactant.
    - Parental consent signed.
    - Prematuros con edad gestacional menor de 32 semanas nacidos que ingresen en la Unidad Neonatal.
    - Pacientes que requieran tratamiento con surfactante intratraqueal
    - Cuyos padres han firmado el consentimiento informado.
    E.4Principal exclusion criteria
    - Infants with known major congenital anomalies (eg. congenital upper airway obstruction, congenital lung anomaly, severe pulmonary hypoplasia, hydrops, neuromuscular diseases, chromosomopaties)
    - Infants with poor prognosis and risk of imminent death
    - Infants who have received the first dose of surfactant before of the enrollment to the study.
    - Malformaciones congénitas de la vía aérea superior, hídrops, cromosomopatía, enfermedad neuromuscular.
    - Pacientes que ingresen en cuidados paliativos.
    - Pacientes que hayan recibido la primera dosis de surfactante intratraqueal antes de su incorporación al estudio (por ejemplo trasladados de otro centro donde han recibido la primera dosis de surfactante)
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of the lung ultrasound score by 2 points.
    Reducción del score pulmonar en 2 puntos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 and 28 days of life.
    7 y 28 días de vida.
    E.5.2Secondary end point(s)
    Reduction of the total days of supplemental oxygen therapy by 5 days.
    Reducción de 5 días de tratamiento con oxígeno suplementario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days of life a nd 36 weeks of corrected gestational age.
    28 días de vida y 36 semanas de edad gestacional postmenstrual
    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 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) No
    E.8.2.2Placebo Yes
    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 paciente a los 2 años de edad.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 Yes
    F.1.1Number of subjects for this age range: 70
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 70
    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) 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 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 state70
    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 Decision2021-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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