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    Summary
    EudraCT Number:2013-002202-31
    Sponsor's Protocol Code Number:POL7080-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-01
    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 number2013-002202-31
    A.3Full title of the trial
    A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment.
    Estudio de fase II abierto y multicéntrico para evaluar la tolerabilidad, seguridad, eficacia y farmacocinética/farmacodinamia (FC/FD) de POL7080 en el tratamiento de pacientes con exacerbación aguda de la bronquiectasia no asociada a fibrosis quística, causada por infección por Pseudomonas aeruginosa que requiere tratamiento intravenoso
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.
    Estudio realizado en varios hospitales para verificar la tolerancia, seguridad y eficacia de la medicación del estudio (POL7080) y su distribución en el cuerpo cuando se administra a pacientes con bronquiectasia causada por la bacteria Pseudomonas aeruginosa, que requiere tratamiento por vía intravenosa.
    A.3.2Name or abbreviated title of the trial where available
    POL7080-002
    POL7080-002
    A.4.1Sponsor's protocol code numberPOL7080-002
    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 SponsorPolyphor Ltd.
    B.1.3.4CountrySwitzerland
    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 supportPolyphor Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support
    B.5.2Functional name of contact pointNúria Bordas
    B.5.3 Address:
    B.5.3.1Street AddressC/ Consell de Cent 331-336
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34931850229
    B.5.5Fax number+34931850257
    B.5.6E-mailnuria.bordas@tfscro.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 No
    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.3.1Product namePOL7080
    D.3.2Product code POL7080
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOL7080
    D.3.9.1CAS number 944252-63-5
    D.3.9.2Current sponsor codePOL7080
    D.3.9.3Other descriptive namePOL7080
    D.3.9.4EV Substance CodeSUB120823
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typePOL7080 is a synthetic cyclic peptide consisting of 14 amino acids.
    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
    Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.
    Exacerbación aguda de la bronquiectasia no asociada a fibrosis quística, causada por infección por Pseudomonas aeruginosa.
    E.1.1.1Medical condition in easily understood language
    Worsening bronchiectasis caused by Pseudomonas aeruginosa bacterium
    Empeoramiento de la bronquiectasia causada por la bacteria Pseudomonas aeruginosa.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    To investigate the efficacy of POL7080 administered for 14 days in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.
    Investigar la eficacia de POL7080 administrado durante 14 días para el tratamiento de pacientes con exacerbaciones agudas de la bronquiectasia no asociada a fibrosis quística debidas a una infección por Pseudomonas aeruginosa.
    E.2.2Secondary objectives of the trial
    To investigate POL7080 for the following parameters:

    a.Safety and tolerability.
    b.Pharmacokinetics/pharmacodynamics of POL7080.
    Investigar POL7080 en los siguientes parámetros:

    a.Seguridad y tolerabilidad.
    b.Farmacocinética/farmacodinamia de POL7080.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male* and female** aged ?18 to <80 and suffering from documented non-cystic fibrosis bronchiectasis***.
    * Men should practice contraception up to 75 days after the end of treatment.
    **Women of child bearing potential should practice a reliable method of contraception up to 30 days after the end of treatment.
    ***The diagnosis of bronchiectasis must have been made by high-resolution computed tomography or by bronchogram and documented in the patient?s record.
    2. Patients currently having an exacerbation with:
    Increased cough.
    Increased volume of sputum production.
    Increase in sputum purulence.
    3. Patients with documented Pseudomonas aeruginosa infection for the current episode or a positive rapid test for Pseudomonas aeruginosa in the sputum at inclusion or known to be chronically infected with Pseudomonas aeruginosa in the past or isolation of Pseudomonas aeruginosa in the sputum culture at least 2 times in the last 12 months prior to inclusion (from patient records).
    4. Sputum sample collected for quantitative culture before starting treatment.
    5. Venous access available for IV dosing.
    6. Written informed consent from patient.
    1. Hombres* y mujeres** con edades comprendidas entre ?18 años y <80 años con bronquiectasia*** no asociada a fibrosis quística documentada.
    * Los hombres deben utilizar métodos anticonceptivos durante los 75 días siguientes a la finalización del tratamiento.
    ** Las mujeres en edad fértil deben utilizar métodos anticonceptivos fiables durante los 30 días siguientes a la finalización del tratamiento.
    ***El diagnóstico de bronquiectasia debe haberse realizado mediante tomografía computerizada de alta resolución o mediante broncograma y estar documentado en la historia del paciente.
    2. Pacientes que en la actualidad sufren una exacerbación con:
    Aumento de la tos.
    Aumento en el volumen de producción de esputo.
    Aumento en la purulencia del esputo.
    3. Pacientes con infección por Pseudomonas aeruginosa documentada para el episodio en curso, o que den positivo en una prueba rápida para Pseudomonas aeruginosa en esputo en el momento de la inclusión, o con infección crónica por Pseudomonas aeruginosa conocida en el pasado, o en los que se haya aislado Pseudomonas aeruginosa en el cultivo del esputo al menos 2 veces en los 12 meses previos a la inclusión (por los datos de la historia del paciente).
    4. Muestra de esputo recogida para cultivo cuantitativo antes de iniciar el tratamiento.
    5. Disponibilidad de un acceso venoso para la administración i.v.
    6. Consentimiento informado por escrito del paciente
    E.4Principal exclusion criteria
    1. Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception (in women of child bearing age). Men who are unwilling to follow contraception.
    2. Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis.
    3. Current exacerbation of bronchiectasis is associated with lung abscess or empyema.
    4. Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa.
    5. Change or addition to maintenance anti-pseudomonas antibiotics including inhalation antibiotics within 4 weeks prior to current exacerbation.
    6. Change or increase in total daily dose of maintenance macrolide antibiotics within 8 weeks prior to current exacerbation.
    7. Change or increase in total daily dose of systemic or local corticosteroids or NSAIDs within 8 weeks prior to current exacerbation.
    8. Patients with known HIV infection with CD4+ cell count < 200/mm3.
    9. Patients with life threatening arrhythmia identified at study baseline or having been diagnosed and/or treated for life threatening arrhythmia in the last 6 months.
    10. Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 6 weeks of study entry.
    11. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent.
    12. Creatinine clearance <60mL/min.
    1. Mujeres embarazadas o en periodo de lactancia o que no desean usar un método anticonceptivo fiable (en mujeres en edad fértil). Hombres que no desean utilizar anticonceptivos.
    2. Pacientes con fibrosis quística, infección pulmonar por micobacterias activa, enfermedad pulmonar obstructiva crónica terminal u oxígenoterapia de larga duración, asma grave no controlada, sarcoidosis activa o aspergilosis broncopulmonar alérgica.
    3. Exacerbación actual de bronquiectasia asociada a absceso pulmonar o empiema.
    4. Sospecha o confirmación de que el episodio de exacerbación actual se debe a patógenos diferentes de Pseudomonas aeruginosa.
    5. Cambio en los antibióticos antipseudomonas de mantenimiento, o adición de nuevos antibióticos, incluidos los antibióticos inhalados, en las 4 semanas previas a la exacerbación actual.
    6. Cambio o aumento en la dosis total diaria de antibióticos macrólidos de mantenimiento en las 8 semanas previas a la exacerbación actual.
    7. Cambio o aumento en la dosis total diaria de AINE o corticoesteroides locales o sistémicos en las 8 semanas previas a la exacerbación actual.
    8. Pacientes con diagnóstico de infección por el virus del VIH con una cifra de linfocitos CD4+ < 200/mm3.
    9. Pacientes con arritmia potencialmente mortal identificada en el momento basal del estudio, o a los que se les ha diagnosticado y/o tratado por arritmia en los últimos 6 meses.
    10. Morbilidad concomitante de tal gravedad que es probable que el paciente fallezca o presente afecciones médicas graves en las 6 semanas posteriores a la inclusión en el estudio.
    11. Pacientes que actualmente participan en un estudio con otro producto sanitario o producto en fase de investigación clínica, o que haga menos de 30 días que han finalizado un estudio con otro producto sanitario o producto en fase de investigación, o pacientes que estén recibiendo otro fármaco en fase de investigación.
    12. Aclaramiento de creatinina <60ml/min.
    E.5 End points
    E.5.1Primary end point(s)
    Sputum Bacterial clearance [reduction in the daily quantitative viable counts of (cfu/mL) Pseudomonas aeruginosa by at least 1-log].
    Aclaramiento bacteriano del esputo [reducción en los recuentos viables cuantitativos diarios de (UFC/ml) Pseudomonas aeruginosa en al menos una unidad logarítmica].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be evaluated througout the study
    El criterio principal de valoración se evaluará durante todo el estudio
    E.5.2Secondary end point(s)
    1. Safety and tolerability of POL7080 by evaluating adverse events (AEs), changes in vital signs, physical examination results, blood chemistry, haematology and ECG parameters.
    2. Pharmacokinetics/pharmacodynamics of POL7080, by assessing the correlation of selected PK parameters of POL7080 with primary end points and selected secondary end points.
    3. Time to log reductions in cfu/mL of Pseudomonas aeruginosa as compared to baseline.
    4. 24-h sputum volume.
    5. Sputum purulence score.
    6. Total WBC count, serum C-reactive protein (CRP) and procalcitonin (PCT).
    7. Lung function tests: FEV1 (% predicted), FVC (% predicted), FEV1/FVC ratio.
    8. Microbiology:
    a) The in vitro susceptibility [(MIC - minimum inhibitory concentration performed at the central laboratory) of POL7080 and selected anti pseudomonas antimicrobials for the baseline Pseudomonas aeruginosa isolates will be summarised and compared.
    b) All Pseudomonas aeruginosa isolates that show any increase in MIC to POL7080, as compared to baseline, during the daily sputum culture will be summarized. The sero typing results of such isolates will also be presented.
    c) Microbiological response at TOC.
    9. Patient Reported Outcome (PRO): Leicester Cough Questionnaire (LCQ), St. George`s Respiratory Questionnaire (SGRQ).
    10. Evaluation of following biomarkers: Sputum Myeloperxidase (SMPO), Sputum Elastase Activity (SEA), sputum cell counts, IL6 and IL8 (wherever possible).
    1. Seguridad y tolerabilidad de POL7080 administrado mediante la evaluación de acontecimientos adversos (AA), alteraciones de las constantes vitales, resultados de la exploración física, bioquímica sanguínea, hematología y parámetros del ECG.
    2. Farmacocinética/farmacodinamia de POL7080, mediante la evaluación de la correlación de ciertos parámetros FC de POL7080 con los criterios principales de valoración y los criterios secundarios de valoración correspondientes.
    3. Tiempo hasta la reducción logarítmica en UFC/ml de Pseudomonas aeruginosa, en comparación con el periodo basal.
    4. Volumen de esputo durante 24 horas.
    5. Valor de purulencia del esputo.
    6. Recuento total de leucocitos, Proteína C reactiva (PCR) y procalcitonina (PCT).
    7. Pruebas de la función pulmonar: FEV1 (porcentaje previsto), FVC (porcentaje previsto), relación FEV1/FVC.
    8. Microbiología:
    a) Se resumirá y comparará la sensibilidad in vitro [(CIM - concentración inhibitoria mínima, realizada en el laboratorio central) de POL7080 y de determinados antibióticos antipseudomonas para las cepas basales aisladas de Pseudomonas aeruginosa.
    b) Se resumirán todas las cepas aisladas de Pseudomonas aeruginosa que muestren un incremento de la CIM con POL7080, en comparación con el valor basal, durante el cultivo del esputo diario. También se presentarán los resultados del serotipado de estas cepas.
    c) Respuesta microbiológica en el TOC.
    9. Resultados comunicados por el paciente (RCP): Cuestionario de la tos de Leicester (LCQ), Cuestionario respiratorio del hospital St. George (SGRQ).
    10. Evaluación de los biomarcadores siguientes: Concentración de mieloperoxidasa en esputo (SMPO), Actividad de elastasa en esputo (SEA), recuento celular en esputo, IL6 y IL8 (cuando sea posible).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint will be evaluated througout the study
    Los criterios secundarios de valoración se evaluaran durante todo el estudio.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerance
    tolerabilidad
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 EEA4
    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 No
    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
    End of study: Test of cure (TOC) assessment for the last patient.
    Test-of-Cure (TOC) is the time of the primary end point assessment at 4± 1 day after EOT.
    Fin del estudio: Visita Test de curación (TOC) para el último paciente.
    Test de curación (TOC) es el momento de la evaluación del criterio principal de valoración 4 ± 1 días después del FdT.
    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 months7
    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 months7
    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 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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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