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    Summary
    EudraCT Number:2008-000164-17
    Sponsor's Protocol Code Number:tobra nasal CF pilot
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000164-17
    A.3Full title of the trial
    Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei
    Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.

    Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways.
    A.3.2Name or abbreviated title of the trial where available
    tobra nasal CF pilot
    A.4.1Sponsor's protocol code numbertobra nasal CF pilot
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Jena
    B.1.3.4CountryGermany
    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 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 Gernebcin 80 mg
    D.2.1.1.2Name of the Marketing Authorisation holderInfectoPharm GmbH, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGernebcin 80 mg
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPEndosinusial use
    Inhalation use
    Nasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtobramycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
    E.2.2Secondary objectives of the trial
    1. drug safety of nasal Tobramycin (only for pilot-study)
    - Serum levels in non-toxic range
    - mucosal tolerance
    2. Changes of the Sino-nasal-outcome test SNOT-20 adapt CF
    / patient`s diary
    3. detection of P. aeruginosa in sputum / througt swap
    4. Genotyping of P. aeruginosa
    5. Changes in rhinoscopic findings (size of polyps, mucosa, secretions)
    6. Changes in rhinomanometric findings (pilot study)
    7. Cytology, Cytokines in nasal lavage
    8. Incidence of rhinosinusitic and pulmonal exazerbations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has a confirmed diagnosis of cystic fibrosis based on:
    3 positive sweat chloride tests and/or genetic characterisation
    2. detection of P. aeruginosa in nasal lavage (culture) with chronic P.
    aeruginosa colonization of the lung (from day – 28)
    3. informed consent of the patients or parents
    4. Subject is older than 7 years
    5. Subject is able to comply with the inhalation procedures and nasal
    lavage procedures scheduled in the protocol.
    6. Women of childbearing potential are only included into the study, if they
    are using an effective method of birth control during the protocol (e.g.
    implants, combined oral contraceptives, injectables, some IUDs, sexual
    abstinence or vasectomised partner)
    E.4Principal exclusion criteria
    1. subject has a critical condition defined as:
    FEV1 < 30% and / or
    SaO2 < 93% without O2-substitution; need of O2-substitution
    2. Subject had an ENT surgery within 3 months prior to study
    3. Subject shows signs of nasal bleeding
    4. Subject has an ear drum perforation
    5. Subject had an acute rhinosinusitis or a pulmonary exacerbation at study
    entry with need of additional systemic antibiotic therapy against
    pseudomonas aerug.
    6. Subject is unlikely to comply with the procedures scheduled in the protocol
    7. Subject has a known allergic reaction to the medication
    8. Subject is pregnant or breastfeeding
    9. Subject participates in another clinical trial within 30 days prior to study
    entry or 30 days after end of the study.
    10. Systemic (oral or intravenous) antibiotic treatment against P.a. 14 days
    prior to the inclusion and during the study
    11. If serum level of tobramycin is above 2 mg/l one hour after inhalation,
    subject has to withdraw the participation in the study.
    12. progressed renal insufficiency
    13. severe damage of the N. acusticus
    14. dissiness (potential damage of N. vestibularis)
    E.5 End points
    E.5.1Primary end point(s)
    Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 Information not present in EudraCT
    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
    The end of the trial will be reached, when the last subject completes his last visit.
    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 months2
    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.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-05-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 (> 7 years)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 14
    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)
    After the study the patients get their usual treatment. Normaly this takes place in their CF-centre.
    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 Decision2008-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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