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    Summary
    EudraCT Number:2005-004103-10
    Sponsor's Protocol Code Number:CTP-G007.05, Protocol Amendment 02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-004103-10
    A.3Full title of the trial
    Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections
    A.4.1Sponsor's protocol code numberCTP-G007.05, Protocol Amendment 02
    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 SponsorPARI Pharma GmbH
    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 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 nameTobramycin 100 PARI
    D.3.2Product code T100 PARI
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 to 1,5
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.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 Yes
    D.2.1.1.1Trade name Tobi
    D.2.1.1.2Name of the Marketing Authorisation holder4 9612.00.00
    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 nameTOBI®
    D.3.4Pharmaceutical form Inhalation vapour, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 to 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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic Fibrosis with Pseudomoas aeuriginosa infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the bioavailability in the Tobramycin 100 PARI / eFlow treatment group compared to the TOBI® / PARI LC PLUS / PRONEB® ULTRA compressor treatment group. Both groups of patients will be treated during a period of 28 days, receiving the study medication twice a day.

    1. Evaluation of serum and sputum levels of the new formulation Tobramycin 100 PARI containing 150 mg / 1.5 ml Tobramycin nebulized via eFlow®, compared with the registered TOBI® nebulized via PARI LC PLUS. Primary endpoint is plasma tobramycin levels at day 7.
    2. Evaluation of safety data: safety of Tobramycin 100 PARI will be determined for 28 days treatment in 30 CF patients. The active control arm has 30 CF patients receiving TOBI standard therapy.


    Primary endpoint:
    Pharmacokinetics: serum Tobramycin levels at day 7
    E.2.2Secondary objectives of the trial
    - Sputum Tobramycin levels at days 1, 7 and 28, measured 10 minutes after end of inhalation.
    - Trough tobramycin plasma levels at days 1 and 28, measured before inhalation of study medication.

    Tolerability:

    - Bronchospasm: number and relative percentage of patients with bronchospasm (defined as a fall in FEV1 > 15% at 30 min after the end of inhalation)
    - Fall of FEV1 in percent from pre- to post treatment

    Safety endpoints:

    - Extreme cough or wheezing or onset of respiratory distress.
    - Frequency and severity of dyspnea.
    - Audiology: audiological alterations and signs of tinnitus will be recorded.
    - Proportion of subjects reporting advers events.
    - Proportion of subjects with laboratory test abnormalities.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients older than 8 years of age.
    - Subjects with documented CF: Documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for AF508 genetic mutation (or heterozygosity for two well characterized mutations) and two clinical findings consistent with CF.
    - Ability to perform reproducible spirometry.
    - Stable condition with no exacerbation requiring IV antibiotics or hospitalization within one months period prior to screening visit.
    - No change in FEV1 bigger than 20% from baseline within one month period prior to screening visit.
    - Documented P. aeruginosa presence in a sputum/throat culture within 6 months prior to screening or at least two consecutive positive P. aeruginosa cultures within one year.
    - FEV1 at least of 40% of predicted, based on gender, age and height.
    - Room air oximetry from at least 88% saturation.




    E.4Principal exclusion criteria
    1. Use of an investigational drug within 30 days prior to study entry or during the trial.
    2. Active drug and alcohol abuse.
    3. Inability to handle the study inhalers or to inhale the test formulations.
    4. Inability to adhere to the requirements of the protocol.
    5. FEV1 lesst han 40% predicted.
    6. Administration of any anti pseudomonas antibiotics by any route within 7 days prior to initial study drug administration, with the exception of macrolide, provided that these are taken as a maintenace therapy at least 6 weeks before entering the trial.
    7. Severe respiratory infection within one month prior to screening, which requires hospital admission or treatment with intravenous antiobiotics
    8. Positive urine pregnancy test.
    9. Hemoptysis > 60 cc at any time within thirty days prior to study drug administration.
    10. Known local or systemic hypersensitivity to aminoglycosides.
    11. Serum creatinine = or greater than 1,2 mg/d, BUN = 20 mg/dl or greater, or an abnormal urine analysis defined as more than 1+ proteinuria in urinstix.
    12.History of sputum culture or throat swab culture yielding B.cepacia in the
    previous 12 months and/or sputum or throat swab culture yielding B. cepacia at
    screening.
    13. Presence of allergic bronchopulmonary aspergillosis (ABPA) as evidenced by
    positive cultures for aspergillosis, positive skin test and IgE>1000 IU.
    14. Patients with right side heart failure.
    15. Non-compliance with recommended pulmonary rehabilitation
    16. Significant liver disease clinically diagnosed.
    17. Patients with history of GI bleeding.
    18. Patients with known or suspected neuromuscular dysfunction.
    19. Patients with known or suspected auditory or vestibular dysfunction.
    20. Women of childbearing potential and sexually active who are not already using a high effective method of contraception.


    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics: serum Tobramycin levels at day 7: trough level, peak level and area under the curve (AUC).
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    See study protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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) 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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    There are not plans for special treatments or a different care after the subjects have ended their participation in the trial. Patients will continue with their respective treatments under follow up from their specialist.
    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 Decision2006-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-07
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