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    Summary
    EudraCT Number:2012-001585-14
    Sponsor's Protocol Code Number:EPJ-2012
    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:2012-10-29
    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 number2012-001585-14
    A.3Full title of the trial
    Effect of the elimination of colonization by Pneumocystis jirovecii on inflammatory response in patients with chronic obstructive pulmonary disease
    Efecto de la eliminación de la colonización por Pneumocystis jirovecii sobre la respuesta inflamatoria en pacientes con enfermedad pulmonar obstructiva crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the treatment for Pneumocystis jirovecii in patients with chronic obstructive pulmonary disease.
    Evaluación del tratamiento contra Pneumocystis jirovecii en pacientes con enfermedad pulmonar obstructiva crónica
    A.4.1Sponsor's protocol code numberEPJ-2012
    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 SponsorFISEVI
    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 supportAndalusian Regional Ministry of Health
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCICEC Hospital Virgen del Rocio
    B.5.2Functional name of contact pointClara M. Rosso Fernández
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Manuel Siurot s/n
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number34955013414
    B.5.5Fax number34954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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 Wellvone
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline, 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.3.1Product nameWellvone
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    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 INNATOVAQUONE
    D.3.9.1CAS number 95233-18-4
    D.3.9.4EV Substance CodeSUB05602MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 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 obstructive pulmonary disease
    Enfermedad pulmonar obstructiva crónica
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease
    Enfermedad pulmonar obstructiva crónica
    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 10064107
    E.1.2Term Pneumocystis jiroveci infection
    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 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 effect of atovaquone on systemic inflammatory activity in patients with chronic obstructive pulmonary disease colonized by P. jirovecii.
    Conocer el efecto del tratamiento con atovacuona sobre la actividad inflamatoria sistémica en los pacientes con enfermedad pulmonar obstructiva crónica colonizados por P. jirovecii.
    E.2.2Secondary objectives of the trial
    1. To assess the effectiveness of atovaquone in the eradication of P. jirovecii in patients with chronic obstructive pulmonary disease .

    2. To evaluate the decrease in systemic inflammatory response after a specific treatment against P. jirovecii in patients with chronic obstructive pulmonary disease.
    1. Conocer la eficacia de la atovacuona en la erradicación de la colonización por P. jirovecii en pacientes con enfermedad pulmonar obstructiva crónica.

    2. Evaluar la disminución de la respuesta inflamatoria sistémica tras un tratamiento específico frente a la colonización por P. jirovecii en pacientes con enfermedad pulmonar obstructiva crónica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients over 39 years old.
    ? Patients who have not submitted an exacerbation in the last 4 months.
    ? Possibility of obtaining a sample of sputum or oropharyngeal wash samples
    ? Informed consetn form
    ? Edad > 39 años
    ? Enfermos que no hayan presentado un episodio de exacerbación en los últimos 4 meses
    ? Posibilidad de obtener una muestra de esputo o lavado orofaríngeo
    ? Consentimiento informado del paciente
    E.4Principal exclusion criteria
    ? Confirmed diagnosis or suspicion of cancer
    ? Presence of autoimmune diseases or asma
    ? Patients infected with HIV
    ? Use of immunosuppressive or treatment with inhaled corticosteroids
    ? Presence of exacerbation and / or pneumonia
    ? Patients with other significant diseases that non-COPD.
    ? Patients with anemia, leukopenia or thrombopenia
    ? Patients with impaired renal function (serum creatinine 1.5 x upper limit of normal)
    ? Patients with diagnosis of liver cirrhosis or chronic hepatitis
    ? Pregnant, nursing or childbearing women who are not using contraception method at least in previous three months of the trial during this.
    ? Participation in another trial with an IMP in 30 days previous or 6 semividas (the larger of both)
    ? Hipersensibility to atovaquone
    ? Lost follow-up
    ? Diagnóstico confirmado o sospecha de neoplasia
    ? Presencia de enfermedades autoinmunes o asma.
    ? Presencia de infección por el VIH.
    ? Utilización de inmunosupresores o necesidad de tratamiento con corticoides inhalados.
    ? Presencia de exacerbación y/o neumonía.
    ? Pacientes con otras enfermedades significativas que no sean EPOC. Se considera enfermedad significativa cualquier enfermedad o afección que, a juicio del investigador, pueda poner en riesgo la salud del paciente por participar en el estudio o influir sobre los resultados del estudio o sobre la capacidad del paciente para participar en el estudio.
    ? Pacientes con anemia, leucopenia o trombopenia.
    ? Pacientes con deterioro de la función renal (creatinina sérica > 1,5 x límite superior de normalidad).
    ? Pacientes con diagnóstico de cirrosis hepática o hepatitis crónica.
    ?Mujeres embarazadas o lactantes o en edad fértil que no estén utilizando métodos anticonceptivos autorizados médicamente como mínimo tres meses antes del ensayo o durante éste.
    ? Participación en otro ensayo con un fármaco en investigación en los 30 días o 6 semividas (la mayor de las dos).
    ? Hipersensibilidad conocida a la Atovacuona.
    ? Imposibilidad de seguimiento del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    - Over 50% reduction of the values of IL-6 in serum in each patient after treatment.

    - Over 50% reduction of the values of IL-8 in serum in each patient after treatment.

    - Over 50% reduction of the values of TNF-a in serum in each patient after treatment.

    - Over 50% reduction of the values of ICAM-1 in serum in each patient after treatment.
    - Reducción de más del 50% de los valores de IL-6 en suero en cada paciente tras el tratamiento.

    - Reducción de más del 50% de los valores de IL-8 en suero en cada paciente tras el tratamiento.

    - Reducción de de más del 50% de los valores de TNF-? en suero en cada paciente tras el tratamiento.

    - Reducción de de más del 50% de los valores de ICAM-1 en suero en cada paciente tras el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 mes
    E.5.2Secondary end point(s)
    - Over 30% reduction of the values of IL-6 in serum in each patient one month after finishing treatment.

    - Over 30% reduction of the values of IL-8 in serum in each patient one month after finishing treatment.

    -Over 30% reduction of the values of TNF-a in serum in each patient one month after finishing treatment.

    -Over 30% reduction of the values of ICAM-1 in serum in each patient one month after finishing treatment.
    - Reducción de más del 30% de los valores de IL-6 en suero en cada paciente tras un mes de terminado el tratamiento.

    - Reducción de más del 30% de los valores de IL-8 en suero en cada paciente tras un mes de terminado el tratamiento.

    - Reducción de de más del 30% de los valores de TNF-? en suero en cada paciente tras un mes de terminado el tratamiento.

    - Reducción de de más del 30% de los valores de ICAM-1 en suero en cada paciente tras un mes de terminado el tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month
    1 mes
    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 No
    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 Yes
    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 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 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
    LVLS
    Última visita del último sujeto.
    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 months
    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 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: 23
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 23
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 23
    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)
    It is no different from normal treatment of this condition
    No difiere de los cuidados habituales para esta patología
    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 Decision2013-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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