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    Summary
    EudraCT Number:2016-005014-21
    Sponsor's Protocol Code Number:DPI-tobra-kind
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-10-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-005014-21
    A.3Full title of the trial
    Pharmacokinetic evaluation and tolerability of dry powder tobramycin via the Cyclops® in children with cystic fibrosis
    Farmacokinetische evaluatie en verdraagzaamheid van droog poeder tobramycine via de Cyclops® bij kinderen met mystische fibrose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic evaluation and tolerability of dry powder tobramycin via
    the Cyclops® in children with cystic fibrosis
    Effectiviteit en gebruiksvriendelijkheid van droog poeder inhalatie met
    tobramycine bij kinderen met cystische fibrose
    A.3.2Name or abbreviated title of the trial where available
    DPI-tobra-child
    DPI-tobra-kind
    A.4.1Sponsor's protocol code numberDPI-tobra-kind
    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 SponsorUniversity Medical Center Groningen
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointPrincipal investigator AM Akkerman
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700 RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503616161
    B.5.6E-maila.m.akkerman-nijland@umcg.nl
    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 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 nameDry powder tobramycin
    D.3.2Product code J01GB01
    D.3.4Pharmaceutical form Inhalation powder
    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 INNTOBRAMYCIN
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeIt is a bacterial product derived from the amino glycoside antibiotics complex nebramycin produced by a strain of Streptomyces tenebrarius.
    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 nameNebulization tobramycin
    D.3.4Pharmaceutical form Inhalation vapour
    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 INNTOBRAMYCIN
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    D.3.11.13.1Other medicinal product typeIt is a bacterial product derived from the amino glycoside antibiotic complex nebramycin produced by a strain of Streptomyces tenebrarius.
    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
    Lung infections
    Cystische Fibrose
    Luchtweginfecties
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    Lung infections
    Cystische Fibrose / taaislijmziekte
    Luchtweginfecties
    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 investigate the pharmacokinetic properties of dry powder tobramycin
    via the Cyclops® at different dosages in children with cystic fibrosis,
    together with the local tolerability.
    Onderzoek van de farmacokinetiek en de lokale verdraagzaamheid van
    droog poeder tobramycine bij kinderen met cystische fibrose.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical diagnosis of CF and a positive sweat test or two CF-related
    mutations
    - Age 6 - 18 years
    - Ability to breathe through a mouthpiece and to use the Cyclops
    - Ability to perform pulmonary function tests
    - Written informed consent (child and parents)
    - Klinische diagnose van CF met een positieve zweettest of twee CFgerelateerde
    mutaties
    - Leeftijd 6-18 jaar
    - Vermogen om de Cyclops te gebruiken
    - Vermogen om spirometrie te blazen
    - Verkregen informed consent
    E.4Principal exclusion criteria
    - Acute exacerbation
    - FEV1 < 60%
    - Subjects with known or suspected renal, auditory, vestibular of
    neuromuscular dysfunction, or with severe, active haemoptysis
    - History of adverse events on previous tobramycin or other amino
    glycoside use
    - History of adverse events on the use of powder inhaler
    - Concurrent use of cyclosporine, amphotericin B, cephalosporins,
    polymyxins, vancomycin and NSAID's
    - Acute exacerbatie
    - FEV1 < 60%
    - Personen met bekende of vermeende nier-, gehoor of neuromusculaire
    disfunctie, of met ernstige en actieve hemoptysis
    - Voorgeschiedenis met bijwerkingen van eerder tobramycine gebruik of
    andere aminoglycoside
    - Voorgeschiedenis met bijwerkingen van eerder poederinhalatie
    - Gelijktijdig gebruik van ciclosporine, amphothericine B, cefalosporinen,
    polymyxinen, vancomycine en NSAID's
    E.5 End points
    E.5.1Primary end point(s)
    The following pharmacokinetic parameters will be calculated:
    - AUC0 to 8-12 (area under the curve from 0 to 8-12 h)
    De volgende farmacokinetische parameters worden berekend:
    - AUC0 tot 8-12 (area under the curve from 0 tot 8-12 h)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within four weeks after the last test dose
    Binnen vier weken na de laatste test dosering
    E.5.2Secondary end point(s)
    The following pharmacokinetic parameters will be calculated:
    - Actual dose (dose minus remainder in inhaler after inhalation)
    - Cmax (maximum plasma concentration)
    - Tmax (time to maximum plasma concentration)
    - Ka (absorption rate constant)
    - T 1/2 el (terminal elimination half-life)
    - CL/F (clearance following pulmonary administration (F=
    bioavailability))

    Local tolerability of the inhalation of dry powder tobramycin. Both points
    need to have a positive result.
    - Drop of FEV1 of >10% (lung function measurement)
    - Adverse events
    De volgende farmacokinetische parameters worden berekend:- Actuele dosis (dosis minus het restant in de inhaler na inhalatie)
    - Cmax (maximum plasma concentration)
    - Tmax (time to maximum plasma concentration)
    - Ka (absorption rate constant)
    - T 1/2 el (terminal elimination half-life)
    - CL/F (clearance following pulmonary administration (F=
    bioavailability))

    Lokale verdraagzaamheid van de inhalatie van droog poeder
    tobramycine. Beide punten moeten een positief resultaat hebben:
    - Daling van FEV1 of >10% (longfunctie meting)
    - Bijwerkingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet van toepassing
    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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 6-16 years
    Kinderen met leeftijd 6-16 jaar
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children
    Kinderen
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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
    Geen
    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 Decision2020-01-06
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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