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    Summary
    EudraCT Number:2012-003532-23
    Sponsor's Protocol Code Number:CTBM100C2401E1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-21
    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 ConcernedItaly - Italian Medicines Agency
    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
    Estensione della durata di 48 settimane dello studio CTBM100C2401, di fase IV, multicentrico, in aperto, con un solo gruppo di trattamento per valutare la sicurezza a lungo termine di tobramicina polvere per inalazione (Tobramycin Inhalation Powder TIP) in pazienti con fibrosi cistica
    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
    Estensione di uno studio clinico per valutare la sicurezza a lungo termine di tobramicina polvere per inalazione (Tobramycin Inhalation Powder – TIP) in pazienti con fibrosi cistica
    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 FARMA
    B.1.3.4CountryItaly
    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
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@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*448CPS 28MG+10IN
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical 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 codeTBM100C
    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
    Infezione polmonare cronica con pseudomonas aeruginosa in pazienti con la fibrosi cistica
    E.1.1.1Medical condition in easily understood language
    Bacterial infection in cystic fibrosis patients
    Infezione batteriologica in pazienti con la fibrosi cistica
    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 10057582
    E.1.2Term Lung infection pseudomonal
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.2 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 HLT
    E.1.2Classification code 10037132
    E.1.2Term Pseudomonal infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    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).
    Valutare la sicurezza di tobramicina polvere per inalazione (TIP) nel corso di 12 cicli di trattamento (6 cicli di trattamento nello studio principale e 6 cicli di trattamento nello studio di estensione) in termini di incidenza di eventi avversi (Adverse Event – AE) emergenti in corso di trattamento.
    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 respiratoryrelated 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 • PLEASE SEE PROTOCOL
    Valutare gli endpoint di interesse nel corso di 12 cicli di trattamento con TIP (6 cicli di trattamento nello studio principale e 6 cicli di trattamento nello studio di estensione). Gli endpoint di interesse sono definiti come:  Variazione del FEV1 in % del predetto (relativo e assoluto) nel corso di 12 cicli di trattamento con TIP  Variazione assoluta delle unità formanti colonie (Colony Forming Unit – CFU) di P. aeruginosa per grammo di espettorato nel corso di 12 cicli di trattamento con TIP  Variazione della concentrazione minima inibente (Minimal inhibitory concentration – MIC) di tobramicina per P. aeruginosa nel corso di 12 cicli di trattamento con TIP  PER FAVORE VEDERE SINOSSI IN ITALIANO
    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.
    I pazienti eleggibili per l’inclusione nel presente studio devono soddisfare tutti i seguenti criteri: 1. Consenso informato scritto, e assenso (se appropriato) prima dell’effettuazione di qualsiasi procedura correlata allo studio. 2. Soggetti che hanno completato lo studio principale CTBM100C2401 e che sono in grado di aderire a tutti i requisiti del protocollo dello studio di estensione.
    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.
    I pazienti che soddisfano uno qualsiasi dei seguenti criteri non sono eleggibili per lo studio di estensione. 1. Creatinina sierica pari a 2mg/dl o superiore, BUN (Blood Urea Nitrogen - BUN) pari a 40mg/dl o superiore o analisi delle urine anormale definita come proteinuria 2+ o superiore al momento dell’ingresso nello studio di estensione (Visita 15). 2. Utilizzo di diuretici dell’ansa nei 7 giorni precedenti l’ingresso nello studio di estensione. 3. Donne in gravidanza o allattamento, dove la gravidanza è definita come lo stato di una donna dopo il concepimento e fino al termine della gestazione, confermato da un test di laboratorio HCG positivo (&gt; 5 mIU/mL) alla Visita 15. 4. Donne potenzialmente fertili, definite come tutte le donne fisiologicamente in grado di iniziare una gravidanza, a meno che non utilizzino un metodo contraccettivo altamente efficace durante la somministrazione del trattamento in studio. I metodi contraccettivi altamente efficaci comprendono: PER FAVORE VEDERE SINOSSI IN ITALIANO
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of treatment-emergent adverse event
    La variabile primaria di interesse è l’incidenza di eventi avversi (AE) emergenti
    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
    nel corso di 12 cicli di trattamento (studio core ed estensione) e soltanto nella estensione
    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 respiratoryrelated AE 5) Rate of and time to the first use of anti-pseudomonal antibiotics (overall, oral, intravenous) 6) Evaluation of clinical laboratory results and (in selected study sites) audiology
    1) Variazione del FEV1 in % del predetto (relativo e assoluto) nel corso di 12 cicli di trattamento con TIP 2) Variazione assoluta delle unità formanti colonie (Colony Forming Unit – CFU) di P. aeruginosa per grammo di espettorato nel corso di 12 cicli di trattamento con TIP 3) Variazione della concentrazione minima inibente (Minimal inhibitory concentration – MIC) di tobramicina per P. aeruginosa nel corso di 12 cicli di trattamento con TIP 4) Tempo alla prima ospedalizzazione e tasso di ospedalizzazione a causa di AE seri correlati alla patologia respiratoria nel corso di 12 cicli di trattamento con TIP 5) Tempo al primo utilizzo e tasso di utilizzo (complessivo, orale, endovenoso) di antibiotico anti-pseudomonas (diversi da quelli regolarmente programmati come trattamento profilattico) nel corso di 12 cicli di trattamento con TIP 6) Valutazione dei risultati clinici e di laboratorio e audiologia
    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) 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) Visite 15 (basale della estensione), 16, 18, 20, 22, 24, 26, 27 2) Visite 15 (basale della estensione), 16, 18, 20, 22, 24, 26, 27 3) Visite 15 (basale della estensione), 16, 18, 20, 22, 24, 26, 27 4) nel corso di 12 cicli di trattamento (core studio e estensione) e nello studio di estensione soltanto 5) nel corso di 12 cicli di trattamento (core studio e estensione) e nello studio di estensione soltanto 6) Valutazione dei risultati clinici e di laboratorio e audiologia nel corso di 12 cicli di trattamento (studio core e studio di estensione) e soltanto nello studio di estensione
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    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
    Mexico
    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
    LPLV : 24/NOV/2014
    LPLV : 24/11/2014
    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 months19
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months22
    E.8.9.2In all countries concerned by the trial days0
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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
    nessuno
    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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-18
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