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    Summary
    EudraCT Number:2015-004143-39
    Sponsor's Protocol Code Number:SHIP002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-25
    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 ConcernedDenmark - DHMA
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure as
    measured by computed
    tomography (CT). SHIP-CT study.
    A.3.2Name or abbreviated title of the trial where available
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 INNsodium chloride 7%
    D.3.9.1CAS number 7647-14-5
    D.3.9.2Current sponsor codesodium chloride 7%
    D.3.9.3Other descriptive nameSODIUM CHLORIDE 7%
    D.3.9.4EV Substance CodeSUB96293
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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.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 0.9%
    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 INNSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    Cystic fibrosis
    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.
    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.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the PRAGMA-CF total percent disease (%Dis) score (the
    volume
    proportion of the lung with structural airways disease) measured from
    standardized chest CT at 48 weeks between treatment arms
    E.2.2Secondary objectives of the trial
    Compare the PRAGMA-CF sub-scores %Bx (the volume proportion of the
    lung with bronchiectasis) and %TA (the volume proportion of the lung
    with trapped air), as well as airway-to-artery ratios (AA ratios)
    measured
    from chest CT images at 48 weeks between treatment arms
    3. Compare the change in LCI, measured by N2 MBW, from baseline to 48
    weeks between treatment arms.
    4. Elucidate the cross-sectional and 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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of CF as evidenced by one or more clinical features
    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
    pilocarpine iontophoresis (QPIT)
    b) A documented genotype with two disease-causing
    mutations in the CFTR gene
    2. Informed consent by parent or legal guardian
    3. Age ≥ 36 months and ≤72 months at screening visit
    4. Ability to comply with medication use, study visits and study
    procedures as judged by the site investigator
    5. Ability to cooperate with chest CT at the enrolment visit as
    determined by the lung function technician
    E.4Principal exclusion criteria
    Acute intercurrent respiratory infection, defined as an increase in
    cough, wheezing, or respiratory rate with onset within 3 weeks
    preceding screening or enrolment visit
    3. Acute wheezing at screening or enrolment visit
    4. Oxygen saturation < 95% (<90% in centres located above 4000 feet
    elevation) at screening or enrolment visit
    5. Other major organ dysfunction, excluding pancreatic dysfunction
    6. Physical findings that would compromise the safety of the
    participant or the quality of the study data as determined by site
    investigator
    7. Investigational drug use within 30 days prior to screening or
    enrolment visit
    8. Treatment with inhaled HS at any concentration within 30 days prior
    Chest CT within 8 months prior to screening or enrolment visit
    9. Initiation (i.e. new prescription) of any inhaled hydrating agent such
    as mannitol or mucolytic agents such as dornase alpha within 30
    days prior to the screening or enrolment visit
    10. Chronic lung disease not related to CF
    11. Inability to tolerate first dose of study treatment at the enrolment
    visit
    E.5 End points
    E.5.1Primary end point(s)
    The difference in PRAGMA-CF %Dis between HS and IS study arm at end
    of
    study (48 weeks), adjusted for baseline, measured from standardized
    chest
    CT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the whole study.
    E.5.2Secondary end point(s)
    i)The difference in PRAGMA-CF sub-scores, %Dx and %TA, between the
    baseline CT and the 48 week CT.
    ii) The absolute number of airways, airway dimensions and AA ratios
    from TLC CTs, acquired at the 48-week visit.
    2. The difference in LCI, measured by N2 MBW, from baseline to 48
    weeks
    3. Cross-sectional and longitudinal relationships between primary and
    secondary PRAGMA-CF outcomes (%Dis, %Bx and %TA) and MBW
    outcomes (LCI), airway dimensions and PRAGMA-CF and MBW
    outcomes, as well as CFQ-R scores and PRAGMA-CF and MBW
    outcomes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the whole study.
    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 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
    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 thier doctor they can continue to use the study drug.
    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 Decision2017-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-22
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