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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2008-006144-18
    Sponsor's Protocol Code Number:2008001
    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:2009-03-06
    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 number2008-006144-18
    A.3Full title of the trial
    Ensayo clínico aleatorizado doble ciego frente a placebo para evaluación del tratamiento con colistina inhalada en EPOC y/o bronquiectasias no fibrosis quística con infección bronquial crónica por Pseudomonas aeruginosa.
    A.4.1Sponsor's protocol code number2008001
    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 SponsorComplejo Hospitalario Universitario de Albacete. Director Gerente Dr Jesús Martino Sánchez Martínez
    B.1.3.4CountrySpain
    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 COLISTIMETATO DE SODIO GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador
    D.2.1.1.2Name of the Marketing Authorisation holderG.E.S. GENERICOS ESPAÑOLES LABORATORIO, 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for nebuliser 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 INNCOLISTINA MESILATO SODIO
    D.3.9.3Other descriptive nameCOLISTIN MESILATE SODIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 placeboNebuliser solution
    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
    Infección bronquial crónica por Pseudomonas aeruginosa en pacientes con EPOC y/o bronquiectasias no fibrosis quística
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level HLGT
    E.1.2Classification code 10006436
    E.1.2Term Bronchial disorders (excl neoplasms)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Objetivo primario.

    1.1. Evaluar la eficacia a largo plazo del uso de colistina nebulizada en los pacientes con EPOC y/o BQ de origen distinto a FQ con infección bronquial crónica por Pseudomonas aeruginosa desde el punto de vista clínico demostrada por disminución en el nº de exacerbación anuales
    E.2.2Secondary objectives of the trial
    2. Objetivos secundarios.

    2.1 Evaluar la mejoría de síntomas clínicos (tos, expectoración y disnea).

    2.2. Evaluar la mejoría en la calidad de vida según el cuestionario de St George.

    2.3. Evolución en la capacidad funcional (FEV1 y FVC, metros y desaturación en el test de la marcha e índice BODE).

    2.4. Evaluar respuesta microbiológica (número de colonias, aparición de resistencias y de otros microorganismos).

    2.5. Evaluar la respuesta inflamatoria sistémica.

    2.6. Valorar la tolerancia al tratamiento con colistina nebulizada y aparición de efectos secundarios.

    2.7. Conocer la situación epidemiológica de la infección bonquial crónica por Pseudomonas aeruginosa en nuestro medio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Población Elegible
    Pacientes que acudan a las consultas de Neumología del los centros participantes con infección bronquial crónica y aquellos cuyas muestras remitidas al laboratorio de microbiología del complejo hospitalario puedan ser compatibles con colonización crónica por Pseudomonas aeruginosa
    2. Criterios de inclusión de los sujetos:
    -Pacientes mayores de 18 años y adultos con índice de Katz A.
    -EPOC definido según criterios GOLD y/o Bronquiectasias confirmadas por TAC.
    -Colonización bronquial crónica por Pseudomonas aeruginosa
    -Expectoración purulenta.
    -Al menos 3 exacerbaciones infecciosas respiratorias anuales.
    -Situación clínica estable (no presencia de exacerbación de infección bronquial durante las 4 semanas previas a su inclusión en el estudio).
    E.4Principal exclusion criteria
    Criterios de exclusión de los sujetos:
    - Pacientes con fibrosis quística
    - Tratamiento previo con antibiótico inhalado durante los seis meses previos a la inclusión
    - Tratamiento antibiótico durante las 4 semanas previas a su inclusión en el estudio.
    - Pacientes ingresados por exacerbación por infección respiratoria
    -Resistencia al colistimetato de sodio definida como CMI > 128 mcg/ml
    -Intolerancia al colistimetato de sodio inhalado
    -Embarazo
    -Presencia de gérmenes bacterianos concomitantes en el esputo en los últimos 3 meses (Staphyloccocus aureus, Stenotrophomonas maltophilia )
    -VEMS1 < 30% del valor teórico inicial o <1,0 litros
    -Creatinina > 1,5 mg/dl
    -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)
    Variable clínicas basales:

    Edad, sexo, EPOC, bronquiectasias. Tabaquismo, clase funcional de disnea NYHA, tratamiento respiratorio crónico, oxigenoterapia, índice de masa corporal (BMI), esputo de 24 horas (volumen, color) nº de exacerbaciones en último año, test de calidad de vida St George . TAC torácico actual o en año anterior, Analítica general, estudio microbiológico de esputo, antibiograma, espirometría, test de la marcha e índice BODE

    Variables de eficacia primaria

    Nº de agudizaciones anuales

    Variables de eficacia secundaria

    - Eficacia clínica: mejoría en la calidad de vida (St George), disminución de la tos, de la expectoración, reducción de la disnea en la escala de la NYHA y supervivencia.

    - Eficacia funcional: ausencia de deterioro en FEV1 y FVC y en el test de la marcha de 6 minutos e índice BODE.

    - Eficacia microbiológica: disminución en nº de colonias en el recuento semicuantitativo

    - Eficacia inflamatoria: disminución en los parámetros inflamatorios sistémicos

    Variables de seguridad

    Todos los Acontecimientos Adversos (AA) y los (Acontecimientos adversos Graves) AAG deben ser recogidos en la historia clínica y en el CRD, en cada visita deben registrarse en el Formulario de Acontecimientos Adversos específico del CRD todos los AA que el paciente ha presentado desde la visita anterior.

    El promotor del estudio notificará aquellos acontecimientos que sean graves e inesperados que puedan estar relacionados con los tratamientos en investigación (es decir, aquellas reacciones adversas graves e inesperadas) a la Agencia Española del Medicamento y Productos Sanitarios, a los órganos competentes de las comunidades autónomas implicados ensayo) y a los CEICs implicados.

    La notificación se realizará a través del Formulario de Notificación de Sospecha de Reacción Adversa que forma parte del Anexo I de la Circular 15/2001 y que se adjunta como Anexo en el protocolo del estudio. El plazo máximo de notificación será de 15 días naturales a partir del momento en que el promotor haya tenido conocimiento de la sospecha de RA. Aquellas RAG que hayan causado la muerte del sujeto, o puesto en peligro su vida, tendrán un plazo máximo de notificación de 7 días naturales a partir del momento en que el promotor haya tenido conocimiento del mismo. Dicha información se completará, cuando sea posible, durante los 8 días siguientes.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2011-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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