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    Summary
    EudraCT Number:2012-003532-23
    Sponsor's Protocol Code Number:CTBM100C2401E1
    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:2012-11-29
    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 number2012-003532-23
    A.3Full title of the trial
    A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
    Extensión al ensayo CTBM100C2401 de 48 semanas, fase IV, multicéntrico, abierto, con un único brazo para evaluar la seguridad a largo plazo del polvo de tobramicina para inhalación (TIP) en pacientes con Fibrosis Quística
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
    Extensión de un ensayo clinico para evaluar la seguridad a largo plazo del polvo de tobramicina para inhalación (TIP) en pacientes con Fibrosis Quística
    A.4.1Sponsor's protocol code numberCTBM100C2401E1
    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 SponsorNovartis Farmaceutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmaceutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.com
    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 TOBI Podhaler
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/03/140
    D.3 Description of the IMP
    D.3.1Product nameTOBI Podhaler
    D.3.2Product code TBM100C
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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.3.9.1CAS number 32986-56-4
    D.3.9.2Current sponsor codeTBM100
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    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 Yes
    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
    Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
    Infeccion pulmonar cronica con Pseudomonas aeruginosa en pacientes con fibrosis quística
    E.1.1.1Medical condition in easily understood language
    Bacterial infection in cystic fibrosis patients
    Infección bateriana en pacientes con fibrosis quística
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021860
    E.1.2Term Infection pseudomonas aeruginosa
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of Tobramycin Inhalation Powder (TIP) across 12 treatment cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) in terms of the incidence of treatment emergent adverse events (AEs).
    Evaluar la seguridad de tobramicina polvo para inhalación (TIP) durante 12 ciclos de tratamiento (6 ciclos de tratamiento en el estudio principal y 6 ciclos de tratamiento en el estudio de extensión) en cuanto a la incidencia de acontecimientos adversos (AAs) surgidos debido al tratamiento.
    E.2.2Secondary objectives of the trial
    To evaluate endpoints of interest across 12 cycles (6 treatment cycles in the core study and 6 treatment cycles in the extension study) of TIP treatment:
    ? change in FEV1 % predicted (relative and absolute)
    ? absolute change in P. aeruginosa CFU per gram of sputum
    ? change of P. aeruginosa tobramycin MIC
    ? time to first and the rate of the usage (overall, oral, intravenous) of antipseudomonal antibiotic (other than those regularly scheduled as prophylactic
    treatment)
    ? time to first and the rate of hospitalization due to serious respiratory-related AEs
    ? safety profile of TIP in terms of clinical laboratory results and audiology (in a sub-set of patients)
    ? safety profile of TIP in terms of acute change in FEV1 from pre-dose to 30
    minutes post dose
    ? To evaluate the above endpoints of interest (including the primary endpoint of incidence of AEs) across the 6 cycles of treatment in this extension study.
    Evaluar las variables de interés durante 12 ciclos (6 ciclos de tratamiento en el estudio principal y 6 ciclos de tratamiento en el estudio de extensión) del tratamiento con TIP:
    Las variables de interés se definen como:
    ?el cambio en el % previsto de FEV1 (relativo y absoluto) durante 12 ciclos de tratamiento con TIP
    ?el cambio absoluto en las UFC de P. aeruginosa por gramo de esputo durante 12 ciclos de tratamiento con TIP
    ?el cambio en la CMI de tobramicina para P. aeruginosa durante 12 ciclos de tratamiento con TIP
    ?el tiempo hasta el primer uso (general, oral, intravenoso) de antibiótico antipseudomonal (distinto a los normalmente programados como tratamiento profiláctico) y su tasa, durante 12 ciclos de tratamiento con TIP
    ?el tiempo hasta la primera hospitalización debido a AAs graves relacionados con problemas respiratorios, y su tasa, durante 12 ciclos de tratamiento con TIP.
    Referirse al protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent, HIPAA (Health Insurance Portability and Accountability Act) authorization (where
    applicable), and assent (as appropriate) prior to the performance of any study-related procedure.

    2. Completed the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study.
    1. Proporcionar el consentimiento informado por escrito, y asentimiento (según corresponda) antes de realizar ningún procedimiento relacionado con el estudio.
    2. Haber finalizado el estudio principal CTBM100C2401 y poder cumplir todos los requisitos del protocolo del estudio de extensión
    E.4Principal exclusion criteria
    1. Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at entry
    into the extension study (visit 15).

    2. Use of loop diuretics within 7 days prior to entry into the extension
    study.

    3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the
    termination of gestation, confirmed by a positive HCG laboratory test (> 5 mIU/mL) at Visit 15.

    4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are
    using a highly effective method of contraception during dosing of
    study treatment as defined in full protocol.
    1. Creatinina sérica 2 mg/dl o más, BUN 40 mg/dl o más, o un análisis de orina anormal definido como proteinuria 2+ o superior en el momento de la inclusión en el estudio de extensión (visita 15).
    2. Uso de diuréticos de asa en los 7 días previos a la inclusión en el estudio de extensión.
    3. Mujeres embarazadas o en período de lactancia, donde el embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado mediante el resultado positivo de la prueba de laboratorio de HCG (> 5 mIU/mL) en la Visita 15.
    4. Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando un método de anticoncepción altamente eficaz durante la administración del tratamiento del estudio. Ver protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of treatment-emergent adverse event
    Incidencia de acontecimientos adversos surgidos debido al tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Across 12 cycles of treatment (core study and extension) and within the extension alone
    Durante 12 ciclos de tratamiento (6 ciclos de tratamiento en el estudio principal y 6 ciclos de tratamiento en el estudio de extensión)
    E.5.2Secondary end point(s)
    1) Relative change in FEV1% predicted, FVC % predicted and FEF25-75 % predicted from baseline

    2) Relative change in P aeruginosa CFU in sputum from baseline

    3) Change in P aeruginosa tobramycin MIC from baseline

    4) Rate of and time to the first hospitalization due to serious respiratory-related AE

    5) Rate of and time to the first use of anti-pseudomonal antibiotics (overall, oral, intravenous)

    6) Acute change in FEV1% predicted from pre-dose to post-dose 30 minutes

    7) Evaluation of clinical laboratory results and (in selected study sites) audiology
    Las variables de interés se definen como:
    1) el cambio en el % previsto de FEV1 (relativo y absoluto) respecto a la basal
    2) el cambio absoluto en las UFC de P. aeruginosa por gramo de esputo respecto a la basal
    3) el cambio en la CMI de tobramicina para P. aeruginosa respecto a la basal
    5) el tiempo hasta el primer uso de antibiótico antipseudomona (general, oral, intravenoso) y su tasa
    4) el tiempo hasta la primera hospitalización debido a AAs graves relacionados con problemas respiratorios, y su tasa
    7) resultados de los análisis clínicos de laboratorio y audiología (en un subgrupo de pacientes)
    6) cambio agudo en el FEV1 desde antes de la dosis hasta 30 minutos después de la dosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27

    2) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27

    3) Visits 15 (baseline of extension), 16, 18, 20, 22, 24, 26, 27

    4) across 12 cycles of treatment (core study and extension) and within the extension alone

    5) across 12 cycles of treatment (core study and extension) and within the extension alone

    6) Visits 16, 18, 20, 22, 24, 26

    7) Evaluation of clinical laboratory results and (in selected study sites) audiology: across 12 cycles of treatment (core study and extension) and within the extension alone
    1) Visitas 15 (basal de la extension), 16, 18, 20, 22, 24, 26, 27

    2) Visitas 15 (basal de la extension), 16, 18, 20, 22, 24, 26, 27

    3) Visitas 15 (basal de la extension), 16, 18, 20, 22, 24, 26, 27

    4) durante 12 ciclos de tratamiento (estudio principal y extension) y solamente en la extension

    5) durante 12 ciclos de tratamiento (estudio principal y extension) y solamente en la extension

    6) Visitas 16, 18, 20, 22, 24, 26

    7) resultados de los análisis clínicos de laboratorio y audiología (en un subgrupo de pacientes): durante 12 ciclos de tratamiento (estudio principal y extension) y solamente en la extension
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Australia
    Canada
    France
    Germany
    Hungary
    Italy
    Mexico
    Spain
    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
    Ultima visita del ultimo paciente
    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: 25
    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: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children : written informed consent given by adult subjects or by the parents/legal guardian on behalf of the subject
    Niños: proporcionar consentimineto informado por escrito por un adulto o por los padred/ tutores legales en represenación del paciente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    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)
    None
    Ninguno
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-18
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