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    Summary
    EudraCT Number:2016-001238-89
    Sponsor's Protocol Code Number:FACE
    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:2016-04-20
    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 number2016-001238-89
    A.3Full title of the trial
    IRON DEFICIENCY IN PATIENTS WITH COPD: IMPACT OF TOPPING WITH IRON CARBOXYMALTOSE. FACE STUDY (ASSESSMENT IN PATIENTS WITH FERINJECT AND IRON DEFICIENCY COPD TO IMPROVE EXERCISE TOLERANCE)
    DEFICIENCIA DE HIERRO EN PACIENTES CON EPOC: IMPACTO DE LA REPOSICIÓN CON HIERRO CARBOXIMALTOSA. FACE STUDY (FERINJECT ASSESSMENT IN PATIENTS WITH COPD AND IRON DEFICIENCY TO IMPROVE EXERCISE TOLERANCE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of iron replacement in patients with chronic obstructive pulmonary disease
    Impacto de la reposición de hierro en pacientes con enfermedad pulmonar obstructiva crónica
    A.4.1Sponsor's protocol code numberFACE
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    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 supportno
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital del Mar
    B.5.2Functional name of contact pointServicio de Neumología
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim, 25-29
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932483056
    B.5.5Fax number0034932483425
    B.5.6E-mailDARodriguez@parcdesalutmar.cat
    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 Ferinject 50 mg/ml Solución inyectable y para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France, 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 Solution for injection
    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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 1000
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Iron deficiency in Chronic obstructive pulmonary disease patients (COPD)
    Deficiencia de hierro en pacientes enfermedad pulmonar obstructiva crónica (EPOC)
    E.1.1.1Medical condition in easily understood language
    Disease of lung inflammation
    Enfermedad de la inflamación de los pulmones
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 if intravenous iron (carboxymaltose) treatment in stable COPD and iron deficiency with or without mild anemia improves exercise tolerance.
    Investigar si el tratamiento con hierro intravenoso (carboximaltosa) en la EPOC estable y déficit de hierro con o sin anemia leve mejora la tolerancia al esfuerzo.
    E.2.2Secondary objectives of the trial
    Investigate whether intravenous iron treatment (carboxymaltose) in stable COPD and improve iron deficiency:
    a) Clinical:
    1. Disease symptoms (measured by the CAT and CRQ questionnaires)
    2. Daily physical activity (measured by accelerometer and IPAQ questionnaire)
    b) Basic:
    3. Increases levels of hepcidin.
    4. Systemic inflammation and oxidative stress response modulate hepcidin.
    Investigar si el tratamiento con hierro intravenoso (carboximaltosa) en la EPOC estable y déficit de hierro mejora:
    a) Clínicos:
    1. Los síntomas de la enfermedad (medido mediante los cuestionarios CAT y CRQ)
    2. La actividad física diaria (medida por acelerómetro y cuestionario IPAQ)
    b) Básicos:
    3. Aumenta los niveles de hepcidina.
    4. La inflamación sistémica y estrés oxidativo modulan la respuesta de la hepcidina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients of both genres aged between 45 and 80 years.
    -Clinical stability for at least 8 weeks prior to inclusion in the study.
    - No change for the last 8 weeks in COPD and comorbidities pharmacotherapy treatment since last antibiotics intake and/ or systemic steroids for COPD exacerbation.
    - Patients who have signed the informed consent indicating that they have been informed of all pertinent aspects of the trial.
    -Pacientes adultos de ambos sexos de edades comprendidas entre los 45 y 80 años.
    -Estabilidad clínica durante al menos 8 semanas previas a la inclusión en el estudio desde la última toma de antibióticos y/o esteroides sistémicos por exacerbación de la EPOC.
    -Tratamiento farmacológico sin cambios durante las últimas 8 semanas tanto de la EPOC como de las comorbilidades.
    -Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo.
    E.4Principal exclusion criteria
    -Cardiovascular, neurological, liver, kidney, musculoskeletal alterarions or uncontrolled psychiatric disorders that prevent the exercise.
    - Asthma diagnosis.
    -Obesity, BMI superior than or equal to 30 kg / m2
    - Any digestive, renal or gynecological loss of blood .
    - Chronic home oxygen therapy.
    - Heart failure with fraction ejection below 60%.
    - Active oncologic disease or that have required treatment in the last year.
    -Allergy or hypersensitivity to carboxymaltose iron or to any of the excipients of the study drug.
    - Hemoglobin equal or below 12g / dl in men and 11 g / dl in women.
    - Dose iron replenish superior of 1000 mg (20 ml carboxymaltose iron) in a week
    - Hypersensitivity to parenteral iron. Use of erythropoietin, iron (oral or intravenous -IV-) or transfusion prior month.
    - Chronic liver disease (transaminases three times under the normal value).
    -Pregnant or breast-feeding.
    -Participation in a clinical drug research before 3 months in pre-drug administration.
    -Alteraciones cardiovasculares, neurológicas, hepáticas, renales, músculo-esqueléticas o trastornos psiquiátricos no controlados que impidan la práctica de ejercicio.
    -Diagnóstico de Asma.
    -Obesidad, IMC mayor o igual a 30 kg/m2
    -Cualquier pérdida de sangre a nivel digestivo, renal o ginecológico.
    -Oxigenoterapia crónica domiciliaria.
    -Insuficiencia cardíaca con fracción de eyección menor del 60%.
    -Enfermedad oncológica activa o que ha requerido tratamiento en el último año.
    -Alergia o hipersensibilidad al hierro carboximaltosa o a alguno de los excipientes del medicamento en estudio.
    -Hemoglobina igual o inferior a 12g/dl en varones y 11 g/dl en mujeres.
    -Dosis de hierro a reponer en una semana mayor de 1000 mg (20 ml de hierro carboximaltosa).
    -Hipersensibilidad al hierro parenteral. Uso de eritropoyetina, hierro (oral o intravenoso -IV-) the previous month.
    -Enfermedad hepática crónica (transaminasas tres inferior veces el valor normal).
    -Mujeres embarazadas o en periodo de lactancia.
    -Participación en alguna investigación clínica con medicamentos dentro de los 3 meses anteriores a la administración del fármaco.
    E.5 End points
    E.5.1Primary end point(s)
    Resistance time cycle ergometer at 75% of the maximum load or Wpico
    Tiempo de resistencia en cicloergómetro al 75% de la carga máxima o Wpico
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks from treatment administration
    4 semanas desde la administración del tratamiento
    E.5.2Secondary end point(s)
    a) CAT and CRQ questionnaires to assess symptoms and quality of life.
    b) Daily physical activity measured by the accelerometer SenseWear® Pro2 Armband (SWA ; Body Media, Pittsburgh , PA) with a record for 7 days of daily physical activity.
    c) Venous blood extraction for laboratory tests (routine blood chemistries, including: serum ferritin, transferrin , transferrin saturation, serum iron , blood count hepatograma) , hepcidin for the biomarkers study related to systemic inflammation and route of hepcidin ( IL - 6, CRP ) plus oxidative stress at a blood level.
    a)Cuestionarios CAT y CRQ síntomas y para valorar calidad de vida.
    b) Actividad física diaria. Se medirá por acelerometría mediante el acelerómetro SenseWear® Pro2 Armband (SWA; Body Media, Pittsburgh, PA) con un registro durante 7 días de la actividad física diaria.
    c) Extracción venosa para analítica (bioquímica sanguínea rutinaria, incluyendo; ferritina sérica, transferrina, saturación de transferrina, hierro sérico, hemograma. hepatograma), hepcidina y para estudio de biomarcadores relacionados con inflamación sistémica y la vía de la hepcidina (IL-6, PCR), además de estrés oxidativo a nivel sanguíneo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks from treatment administration
    4 semanas desde la administración del tratamiento
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    Last visit of the last recruited patient.
    Última visita del último paciente reclutado.
    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 months6
    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 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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state42
    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)
    Patients will receive adequate treatment by their physician.
    Los pacientes recibirán el tratamiento que su médico considere oportuno.
    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 Decision2016-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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