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    Summary
    EudraCT Number:2015-004143-39
    Sponsor's Protocol Code Number:SHIP002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-31
    Trial results View 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 number2015-004143-39
    A.3Full title of the trial
    A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial
    Estudio clínico de fase III, aleatorizado, doble ciego, controlado, con solución hipertónica inhalada al 7% versus solución salina isotónica al 0.9%, durante 48 semanas en pacientes de entre 3 y 6 años con fibrosis quística, en paralelo con el estudio SHIP en Norte América.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Saline hypertonic in preschoolers and lung structure as measured by computed tomography.
    Solución salina hipertónica en pacientes preescolares y estructura pulmonar medida mediante tomografía computerizada
    A.3.2Name or abbreviated title of the trial where available
    Ship-CT study
    Ship-CT study
    A.4.1Sponsor's protocol code numberSHIP002
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportCystic Fibrosis Foundation Therapeutics (CFFT)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointProgram manager
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80, room Sb-2672
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031010703668
    B.5.6E-mailshipCTstudy@erasmusmc.nl
    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 No
    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 nameHypertonic saline
    D.3.4Pharmaceutical form Inhalation solution
    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 INNHYPERTONIC SALINE
    D.3.9.2Current sponsor codeHYPERTONIC SALINE
    D.3.9.3Other descriptive nameSALINE
    D.3.9.4EV Substance CodeSUB20722
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 No
    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 nameIsotonic saline
    D.3.4Pharmaceutical form Inhalation solution
    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 INNISOTONIC SALINE
    D.3.9.2Current sponsor codeISOTONIC SALINE
    D.3.9.3Other descriptive nameSTERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V)
    D.3.9.4EV Substance CodeSUB79490
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Cystic Fibrosis
    Fibrosis quística
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis is a genetic disease that affects mostly the lungs but also the pancreas, liver, kidneys and intestine.
    La Fibrosis quística es una enfermedad genética que afecta principalmente a los pulmones pero también afecta al pancreas, hígado, riñones e intestino
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the difference in PRAGMA-CF total percent disease (%Dis) between HS and IS study arm at end of study (48 weeks), measured from standardized chest CT.
    Comparar la puntuación del % total de PRAGMA-CF (proporción de volumen del pulmón con enfermedad estructural) entre ambos brazos medida mediante una TC de tórax en la semana 48.
    E.2.2Secondary objectives of the trial
    Compare the differences in PRAGMA-CF subscores: the volume proportions of the lung with bronchiectasis (%Bx) and trapped air (%TA), as well as airway dimensions as measured using the AA method measured from chest CT images at 48 weeks between treatment arms.
    Elucidate the longitudinal relationships between measures of structural lung disease evaluated by chest CT (PRAGMA-CF (%Dis, %Bx, %TA) and AA method (AA ratio and airway dimensions), LCI measured by multiple breath washout and clinical outcomes (pulmonary exacerbations, health-related quality of life) over the 48-week treatment period.
    1. Comparar las subpuntuaciones del PRAGMA-CF en ambos brazos de tratamiento, así como los AA ratios medidos mediante una TC de tórax en la semana 48
    2. Comparar los cambios de LCI, medido por N2 MBW, en ambos grupos desde el inicio a la semana 48 semana
    3. Explicar la relación entre las medidas transversales y longitudinales de la enfermedad pulmonar estructural evaluada mediante TC de tórax (PRAGMA-CT %Dis; %Bx; %TA) y el método AA, el LCI calculado mediante MBW y resultados clínicos (exacerbaciones pulmonares, calidad de vida) durante las 48 semanas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: a) A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpineiontophoresis (QPIT) b) A documented genotype with two disease-causing mutations in the CFTR gene
    Informed consent by parent or legal guardian
    Age ≥ 36 months and ≤72 months at Screening visit
    Ability to comply with medication use, study visits and study procedures as judged by the site investigator
    ***Ability to execute a technician controlled or spirometer controlled chest CT scan***????
    1. Diagnóstico de Fibrosis Quística (FQ) por una o más características clínicas con fenotipo positivo para FQ o positivo para FQ Newborn Screen Y uno o más de los siguientes criterios:
    - Presencia documentada de cloro en sudor ≥ 60 mEq/L mediante QPIT
    - Tener documentado un genotipo con dos mutaciones que provoquen la enfermedad en el gen CFTR.
    2. Consentimiento informado firmado por un progenitor o el representante legal
    3. Edad ≥ 36 meses y ≤ 72 meses en el momento de la selección
    4. A criterio del investigador, capacidad de cumplir con el uso de la medicación, visitas y procedimientos del estudio.
    5. Durante la visita de inclusión, capacidad de colaborar en el TC de Tórax según instrucciones del equipo técnico
    E.4Principal exclusion criteria
    Chest CT within 8 months prior to the Screening visit
    Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrolment visit
    Acute wheezing at Screening or Enrollment visit
    Oxygen saturation < 95% (<90% at centres above 4000 feet elevation) at Screening or Enrollment visit
    Other major organ dysfunction, excluding pancreatic dysfunction
    Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
    Investigational drug use within 30 days prior to Screening or Enrolment visit
    Treatment with inhaled hypertonic saline at any concentration within 30 days prior to Screening or Enrolment visit
    Start of any additional inhaled saline solution at any concentration, or other hydrating agent such as mannitol or mucolytic drug such as dornase alpha within 30 days prior or following the Screening or Enrollment visit
    Chronic lung disease not related to CF
    Inability to tolerate first dose of study treatment at the Enrolment visit
    1. TC de Tórax 8 meses antes de la visita de selección
    2. Infecciones respiratorias agudas intercurrentes, definidas como un incremento de tos, silbido o frecuencia respiratoria en las 3 semanas anteriores a las visitas de selección o inclusión.
    3. Silbido agudo durante la visita de selección o inclusión
    4. Saturación de oxígeno < 95% (<90% en hospitales localizados a más de 1219.2 metros sobre el nivel de mar) en la visita de selección o inclusión
    5. Otras disfunciones orgánicas mayores, excepto la disfunción pancreática
    6. A criterio del investigador, hallazgos físicos que pudieran comprometer la seguridad del paciente o la calidad de los datos del estudios.
    7. Uso de otro producto en investigación 30 días antes de la visita de selección o inclusión
    8. Tratamiento con solución salina hipertónica, a cualquier concentración, en los 30 días anteriores a la visita de selección o inclusión.
    9. Inicio en los 30 días anteriores a la visita de selección o inclusión de hidrantentes inhalados como el manitol o agentes mucolíticos como la dornasa alfa.
    10. Enfermedades pulmonares crónicas no relacionadas con la FQ
    11. Incapacidad para tolerar la primera dosis del tratamiento en estudio en la visita de inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in PRAGMA-CF total percent disease (%Dis) between HS and IS study arm at end of study (48 weeks), measured from standardized chest CT.
    La diferencia en PRAGMA-CF entre los brazos HS e IS al final del estudio (semana 48), ajustado en el baseline, medido a través de una TC de tórax.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the whole study
    Durante todo el estudio
    E.5.2Secondary end point(s)
    longitudinal change in airway disease (%Dis), bronchiectasis (%Bx) and trapped air (%TA), as well as the proportion of patients with bronchiectasis progression, from baseline to end of study as established by PRAGMA-CF on expiratory or spontaneous breathing CTs
    Compare the change in LCI, measured by N2 MBW, from baseline to 48 weeks between treatment arms.
    longitudinal change in LCI as measured by nitrogen washout
    protocol-defined pulmonary exacerbation rate
    modified parent-reported CFQ-R for preschool children, a CF-specific measure of health related quality of life (excluding European sites).
    1.
    - Diferencia en las subpuntuaciones de PRAGMA-CF, %Dx y %TA, entre la TC inicial y la TC de las 48 semanas
    - Número absoluto de entradas de aire, sus dimensiones y el ratio AA en la semana 48.
    2. La diferencia de LCI, medido mediante N2 MBW, desde el inicio hasta la semana 48.
    3. Relación transversal y longitudinal entre resultados primarios y secundarios del PRAGMA-CF y los resultados del MBW, dimensión de las entradas de aire y los resultados de PRAGMA-CF y MBW, así como las puntuaciones de CFR-R y los resultados de PRAGMA-CF y MBW.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the whole study
    Durante todo el 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 120
    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)
    In consultation with their doctor they can continue to use the studydrug
    Bajo prescripción médica los pacientes pueden continuar con la medicación 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 Decision2017-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-22
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