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    Summary
    EudraCT Number:2006-004167-56
    Sponsor's Protocol Code Number:027SC06104
    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:2009-04-16
    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 number2006-004167-56
    A.3Full title of the trial
    Prulifloxacino frente a levofloxacino en el tratamiento de pacientes con exacerbaciones agudas de bronquitis crónica (EABC)
    A.4.1Sponsor's protocol code number027SC06104
    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 SponsorA.C.R.A.F. S.p.A.
    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 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 Unidrox ® 600 mg
    D.2.1.1.2Name of the Marketing Authorisation holderA.C.R.A.F. S.p.A.
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrulifloxacin
    D.3.9.1CAS number 123447-62-1
    D.3.9.2Current sponsor codeAF3012 or NM441
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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.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 LEVOXACIN 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE 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 Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevofloxacin
    D.3.9.1CAS number 100986-85-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Exacerbación aguda de bronquitis crónica
    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 prulifloxacino frente al levofloxacino en la visita de control (TOC) en el tratamiento de pacientes con EABC
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia clínica en las visitas de seguimiento a largo plazo (6 semanas, 6 meses tras la finalización del tratamiento o siguiente EABC).

    Evaluar la eficacia microbiológica.

    Seguridad y tolerabilidad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes varones o mujeres, ambulatorios y hospitalizados, de 40 a 75 años de edad sin limitaciones raciales. Las mujeres en edad fértil es necesario que empleen algún método anticonceptivo de eficacia elevada (implantes, inyectables, DIU de cobre y hormonales, abstinencia sexual, pareja vasectomizada) [CPMP/ICH/286/95] y que den negativo a una prueba de embarazo.
    2. Pacientes diagnosticados de Exacerbación Aguda de Bronquitis Crónica*, caracterizada por la presencia de los tres síntomas siguientes o al menos dos incluida la purulencia:
    ? aumento de la disnea,
    ? aumento del volumen de esputo,
    ? aumento de la purulencia del esputo que debe confirmar macroscópicamente el Investigador.
    * La bronquitis crónica se caracteriza por tos y secreción excesiva de moco, y se diagnostica cuando los pacientes refieren producción de esputo la mayoría de los días durante al menos tres meses sucesivos durante 2 ó más años consecutivos.
    3. Pacientes con insuficiencia pulmonar de moderada a grave y que presenten un FEV1 menor o igual al 50% del valor predicho.
    4. Pacientes que precisen iniciar la administración concomitante de corticosteroides sistémicos (20-40 mg/día durante 7 días) o pacientes crónicamente tratados con corticosteroides que precisen aumentar la posología diaria.
    5. Disponibilidad de una muestra válida de esputo de origen broncopulmonar para su evaluación microbiológica, obtenida por expectoración, succión, broncoscopia o lavado bronquial. Las muestras válidas se caracterizarán por < 10 células epiteliales escamosas y > 25 leucocitos polimorfonucleares en campo de baja resolución, 100x aumentos.
    6. Radiografía de tórax negativa para descartar neumonía y tuberculosis activa.
    7. Consentimiento informado por escrito para participar en el ensayo, firmado y fechado por el paciente conforme a la normativa local, obtenido antes de cualquier actividad relacionada con el ensayo.
    E.4Principal exclusion criteria
    1. Hipersensibilidad o alergia a las fluoroquinolonas y/o a cualquiera de los componentes de los medicamentos del estudio.
    2. Asma subyacente
    3. Embarazo y lactancia.
    4. Antecedentes de tendinopatía.
    5. Antecedentes recientes o pasados de cuadros psiquiátricos o epilepsia.
    6. Antecedentes recientes o pasados de cardiopatía, trastornos del ritmo o anomalías clínicamente significativas en el ECG.
    7. Déficit latente o conocido de la actividad de la glucosa-6-fosfato-deshidrogenasa.
    8. Insuficiencia grave conocida hepática y/o renal (AST, ALT y/o niveles de creatinina por encima de dos veces el Límite Superior Normal (LSN)). Si no hubiera analíticas disponibles al requerirse tratamiento, el paciente puede incluirse en el estudio condicionalmente.
    9. Otros cuadros de vías respiratorias inferiores: bronquiectasias graves, fibrosis quística o cáncer de pulmón.
    10. Infecciones y/o neoplasias concurrentes.
    11. Tratamiento concomitante con hipoglucémicos.
    12. Pacientes en tratamiento con fenbufeno y xantinas. Sin embargo, los pacientes tratados con xantinas sí podrían incluirse si se vigilaran los niveles plasmáticos; si las concentraciones plasmáticas pasaran de 10-15 microgramos/ml, el Investigador tendría que reducir la posología diaria de dichas xantinas;
    13. Tratamiento con antibióticos o antibacterianos la semana anterior.
    14. Tratamiento con fármacos experimentales en las 4 semanas previas.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluar la eficacia clínica del prulifloxacino frente al levofloxacino en la visita de control de curación (TOC), en el tratamiento de pacientes con EABC.
    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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 300
    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 Decision2009-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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