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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-004000-30
    Sponsor's Protocol Code Number:TSI-BE-08
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-11-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-004000-30
    A.3Full title of the trial
    Ensayo Clínico Piloto, Aleatorizado, Paralelo, para Evaluar la Eficacia y Seguridad de dos Pautas de Tratamiento con Tobramicina Inhalada, en la Infección Bronquial Crónica por Pseudomonas aeruginosa, en Pacientes con Bronquiectasias no Debidas a Fibrosis Quística
    A.3.2Name or abbreviated title of the trial where available
    TOBI
    A.4.1Sponsor's protocol code numberTSI-BE-08
    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 SponsorServicio de Neumología del Hospital Valle Hebrón
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsor
    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 Tobi® 300 mg/5 ml Solución para nebulizador
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmaceutica S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTobi® 300 mg/5 ml Solución para nebulizador
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTobramicina
    D.3.9.1CAS number 32986-56-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infección bronquial crónica por Pseudomonas aeruginosa en pacientes afectos de bronquiectasias, sin fibrosis quística.
    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
    Evaluar la eficacia clínica del tratamiento con tobramicina inhalada administrada en ciclos de 14 vs 28 días (14 vs 28 días de tratamiento y 14 vs 28 días de descanso respectivamente), en pacientes con bronquiectasias infectadas crónicamente por P.aeruginosa.
    E.2.2Secondary objectives of the trial
    • Evaluar las funciones efectoras fagocíticas y linfocitarias en pacientes con bronquiectasias infectadas crónicamente por P.aeruginosa pre- y post tratamiento con tobramicina inhalada.
    • Evaluar la respuesta inflamatoria a nivel de vías aéreas (y sistémica) en pacientes con bronquiectasias infectadas crónicamente por P.aeruginosa tras la administración de tobramicina inhalada.
    • Evaluar la seguridad de tobramicina inhalada administrada en ciclos de 14 días (con 14 días de descanso), en pacientes con bronquiectasias infectadas crónicamente por P. aeruginosa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pacientes de ambos sexos entre 18 y 75 años de edad.
    • Bronquiectasias confirmadas por tomografía computerizada de alta resolución.
    • Bronquiectasias no debidas a Fibrosis quística (dos pruebas del sudor negativas y no antecedentes familiares)
    • Colonización bronquial crónica por Pseudomonas aeruginosa (3 cultivos de esputo positivos, separados al menos 1 mes entre ellos, de manera consecutiva en un periodo de 6 meses previos al inicio del tratamiento).
    • Expectoración purulenta ≥ 20 ml / diaria
    • Situación clínica estable. No presencia de exacerbación de infección bronquial durante las 4 semanas previas a su inclusión en el estudio.
    • No tratamiento previo con tobramicina inhlada 28 días previos a la inclusión
    • No tratamiento antibiótico durante las 4 semanas previas a su inclusión en el estudio.
    • Consentimiento informado por escrito para la participación en el ensayo clínico.
    E.4Principal exclusion criteria
    • Fibrosis Quística (pruebas del sudor positivas o antecedente familiar de FQ)
    • Resistencia a la tobramicina definida como CMI > 128 mcg/ml
    • Hipersensibilidad a la tobramicina
    • Intolerancia a la tobramicina inhalada (disminución > 20% del Peak-flow a los 15 minutos, 30 minutos, 2 horas o 6 horas post-tratamiento)
    • Embarazo
    • Presencia de gérmenes bacterianos concomitantes en el esputo en el último mes (Staphyloccocus aureus, Stenotrophomonas maltophilia )
    • VEMS1 < 30% del valor teórico inicial o  1,5 litros
    • Creatinina > 1,5 mg/dl
    • Alteración en las pruebas audiométricas
    • Fumadores activos o exfumadores de menos de 1 año
    • Tratamiento inmunosupresor incluidos los corticoesteroides por vía oral o parenteral.
    • Infección por VIH
    • Participación en otro ensayo clínico
    E.5 End points
    E.5.1Primary end point(s)
    Evaluar la eficacia clínica del tratamiento con tobramicina inhalada en pacientes con bronquiectasias infectadas crónicamente por P.aeruginosa.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Information not present in EudraCT
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2008-11-10. 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    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 Decision2009-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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