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    EudraCT Number:2014-004715-37
    Sponsor's Protocol Code Number:M-34273-46
    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:2015-01-26
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-004715-37
    A.3Full title of the trial
    A randomised, double blind, placebo controlled, parallel study to assess the benefits of aclidinium bromide in the relief of COPD symptoms including cough when administered to patients with COPD
    Estudio aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, para evaluar los beneficios del bromuro de aclidinio en la mejoría de los síntomas de EPOC, incluída la tos, en su administración a pacientes con EPOC.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, double blind, placebo controlled, parallel study to assess the benefits of aclidinium bromide in the relief of COPD (Chronic obstructive pulmonary disease) symptoms including cough when administered to patients with COPD.
    Estudio aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, para evaluar los beneficios del bromuro de aclidinio en la mejoría de los síntomas de EPOC (enfermedad pulmonar obstructiva crónica), incluída la tos, en su administración a pacientes con EPOC.
    A.4.1Sponsor's protocol code numberM-34273-46
    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 SponsorAstraZeneca AB; Karlebyhus, Astraallén, Södertälje SE-151 85, Sweden
    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 supportAstraZeneca AB
    B.4.1Name of organisation providing supportMenarini Group through its affiliate Berlin Chemie AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    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. name Eklira Genuair
    D. of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAclidinium bromide 400 µg
    D.3.2Product code LAS34273
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLAS34273
    D.3.9.4EV Substance CodeSUB71687
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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 placeboInhalation powder
    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
    Chronic obstructive pulmonary disease (COPD)
    Enfermedad pulmonar obstructiva crónica (EPOC)
    E.1.1.1Medical condition in easily understood language
    COPD is a chronic lung disease that causes shortness of breath and coughing.
    A bronchodilator helps to open your airways and makes it easier to get air in and out of the lungs.
    EPOC es una enfermedad pulmonar crónica que causa dificultad para respirar y tos. Un broncodilatador ayuda a abrir las vías respiratorias y a conseguir aire dentro y fuera de los pulmones.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the effect of aclidinium bromide 400 micrograms administered twice a day on COPD symptoms including cough in patients with moderate COPD compared to placebo.

    2. To assess the effects of aclidinium bromide 400 micrograms administered twice a day in cough related quality of life measures when administered to the same target population.
    1. Evaluar el efecto del bromuro de aclidinio (400 microgramos) administrado dos veces al día sobre los síntomas de EPOC, incluida la tos, en pacientes con EPOC moderada, en comparación con placebo.

    2. Evaluar los efectos del bromuro de aclidinio (400 microgramos) administrado dos veces al día sobre las medidas de calidad de vida relacionada con la tos en la misma población de referencia.
    E.2.2Secondary objectives of the trial
    not applicable
    no aplicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A reduced group of research centres will participate in a 24-hours cough monitoring substudy. In addition to the main study assessments, all patients enrolled at the substudy centres will have ambulatory cough sound monitoring using a Vitalojak (trade mark) cough monitor (Vitalograph Ltd). Recording will cover the 24 hours preceding Visits 2, 3 and 4, and therefore will require the patient to attend additional visits to the clinic for monitor placement. Patients will be required to report the awakening time and sleep time on the days when the 24 hours cough recording takes place. Approximately 20% of all trial population will take part on this substudy.
    Un reducido grupo de centros de investigación participará en un subestudio de monitorización de la tos durante 24 horas. Además de las evaluaciones del estudio principal, todos los pacientes incluidos en los centros del subestudio serán objeto de monitorización ambulatoria de los sonidos de la tos mediante un monitor de tos Vitalojak (marca registrada) (Vitalograph Ltd). El registro abarcará las 24 horas previas a las visitas 2, 3 y 4, por lo que los pacientes deberán acudir a visitas adicionales al centro para la colocación del monitor. Los pacientes deberán comunicar la hora de despertar y la hora de dormirse los días en los que tenga lugar el registro de tos durante 24 horas. En torno al 20% de la población completa del ensayo participará en este subestudio.
    E.3Principal inclusion criteria
    1. Adult male or non-pregnant, non-lactating female aged >= 40. Women of childbearing potential will follow specific study requirements.
    Explanatory note: A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. Women of childbearing potential are allowed to enter the trial if they show to have a negative urine pregnancy test at the Visit 1 (Screening) and are using, during the last two months before the Screening Visit, at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal intra uterine devices (IUDs), sexual abstinence or vasectomy of the partner.

    2. Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years. Explanatory note: Ex-smoker definition includes those patients who quit smoking more than 6 months prior to the Screening Visit. Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history). When the patient has been smoker during several periods of time separated by inactivity periods, the total pack years resulting from several periods of smoking will be added up.
    Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.

    3. Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1>=50% and <80% and FEV1/FVC < 70%.
    Explanatory note: COPD diagnosis according to GOLD guidelines 2014

    4. Symptomatic patients with a CAT >= 10 at Screening and Randomisation Visit (Visit 1 and 2). Explanatory note: CAT questionnaire cannot be repeated.

    5. Clinical Diagnosis of Chronic Bronchitis (defined as ?presence of cough and sputum production for at least 3 months in each of 2 consecutive years?)

    6. Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained.
    1. Varones y mujeres no embarazadas ni en periodo de lactancia, adultos, ?40 años de edad. Las mujeres potencialmente fértiles deberán observar los requisitos específicos del estudio. Nota explicativa: Se considerará que una mujer es potencialmente fértil a menos que haya sido sometida a una histerectomía, sea posmenopáusica desde hace por lo menos un año o haya sido sometida a una ligadura de trompas. Las mujeres potencialmente fértiles podrán entrar en el ensayo si presentan un resultado negativo en una prueba de embarazo en orina en la visita 1 (selección) y utilizan, desde como mínimo dos meses antes de la visita de selección, por lo menos un método anticonceptivo médicamente aprobado y de gran eficacia, es decir, uno con una baja tasa de fracaso (menos del 1% al año) en su uso de manera constante y correcta; por ejemplo, anticonceptivos implantables, inyectables u orales combinados con al menos un método de barrera, dispositivos intrauterinos (DIU) hormonales, abstinencia sexual o vasectomía de la pareja.
    2. Fumadores o ex fumadores con un índice de consumo de cigarrillos de al menos 10 paquetes/año. Nota explicativa: La definición de ex fumador incluye a los pacientes que hayan dejado de fumar más de 6 meses antes de la visita de selección. El índice de consumo (paquetes/año) se calcula dividiendo el número de cigarrillos fumados al día entre 20 (el número de cigarrillos de una cajetilla) y multiplicando esta cifra por el número de años que ha fumado la persona. Por ejemplo, una persona que fume 40 cigarrillos al día y haya fumado así durante 10 años tendrá un índice de consumo de 20 (40 cigarrillos al día , 20 cigarrillos por cajetilla = 2; 2 x 10 años de consumo de tabaco = 20; índice de consumo = 20 paquetes/año). Si el paciente ha sido fumador durante varios periodos separados por un tiempo sin fumar, se obtendrá el índice de consumo total con la suma de los distintos periodos.
    No se permitirá participar a los pacientes que fumen otros tipos de tabaco, a menos que cumplan también el criterio de cigarrillos.
    3. Pacientes con diagnóstico clínico de EPOC moderada, con resultados disponibles de una prueba posbroncodilatador realizada en los 6 meses anteriores a la visita 1 (selección) que muestren un FEV1 >=50% y <80% y un FEV1/FVC <70%. Nota explicativa: Diagnóstico de EPOC con arreglo a las directrices de 2014 de la COPD.
    4. Pacientes sintomáticos con un CAT >= 10 en las visitas de selección y aleatorización (visitas 1 y 2). Nota explicativa: El cuestionario CAT no puede repetirse.
    5. Diagnóstico clínico de bronquitis crónica (definida como ?presencia de tos y expectoración durante un mínimo 3 meses en cada uno de dos años consecutivos?).
    6. Pacientes elegibles, capaces de participar en el ensayo y que den su consentimiento por escrito para hacerlo después de que se les hayan explicado los objetivos y la naturaleza de la investigación.
    E.4Principal exclusion criteria
    For inclusion and randomisation in the trial, patients must NOT meet any of the following criteria at Visit 1 (Screening) and at Visit 2 prior to randomisation.
    1. History or current diagnosis of asthma.
    2. Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
    3. Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
    4. Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
    5.Patient who in the investigator?s opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
    6. Use of long-term oxygen therapy.
    7. Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates. Explanatory note: The above medication is allowed if taken as stable for at least two months prior to Screening Visit.
    8. Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
    9.Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
    Explanatory note: Patients with symptomatic sleep apnoea syndrome, any disease related with sleep disturbances such as restless-legs syndrome or somnambulism are to be excluded. However the use of continuous positive airway pressure (CPAP) is not an exclusion criteria.
    10. Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)

    11. Patient with a history of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).

    12. Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
    Explanatory note: Patients with well-controlled, stable, asymptomatic benign prostatic hypertrophy are not excluded.
    13. Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis.
    Explanatory note: active hepatitis is defined as clinical symptoms associated with chronic portal inflammation with regional necrosis and fibrosis, which may progress to nodular postnecrotic cirrhosis or patients with antibody to hepatitis B core antigen (anti-HBc) and hepatitis B surface antigen (HBsAg) test with positive results or anti-HCV antibody and HCV RIBAHCV positive tests or genetic material (RNA) testing positive results.
    14. Current diagnosis of cancer other than basal or squamous cell skin cancer.
    15. Patient with any other serious or uncontrolled physical or mental dysfunction. Explanatory note: As judged by the investigator, the dysfunction could place the patient at higher risk derived from his/her participation in the study, could confound the results of the study or is likely to prevent the patient from complying with the requirements of the study or completing the study (e.g. suicidal ideation, mood disorders, personal history of overdose intake).
    16. Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment.
    17. Patient unlikely to be cooperative or that can not comply with the study procedures. Explanatory note: Patients who may have difficulties to follow the treatment, complete the Patient Diaries or attend the clinic at the required times or unable to properly use a DPI or pMDI inhaler device.
    18. Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening).
    19. Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication.
    20. Any other conditions that, in the investigator?s opinion, might indicate the patient to be unsuitable for the study.
    Para su inclusión y aleatorización en el ensayo, los pacientes NO deben cumplir ninguno de los criterios siguientes en la visita 1 (selección) ni en la visita 2 antes de la aleatorización.
    1. Antecedentes o diagnóstico actual de asma.
    2. Pacientes que hayan presentado una exacerbación moderada o severa de la EPOC en el año anterior a la visita 1 (selección) o durante el periodo de preinclusión.
    3. Pacientes que hayan presentado una infección respiratoria en el plazo de las 6 semanas anteriores a la visita 1 (selección) o durante el periodo de preinclusión.
    4. Trastornos respiratorios y cardiovasculares clínicamente importantes que se piense que contribuyen a la tos o que es probable que interfieran en la realización del estudio.
    5. Pacientes que, en opinión del investigador, puedan tener que comenzar un programa de rehabilitación pulmonar durante el estudio y/o pacientes que lo hayan comenzado/finalizado en el plazo de los 3 meses anteriores a la visita de selección.
    6. Uso de oxigenoterapia crónica.
    7. Pacientes en tratamiento no estable con inhibidores de la enzima convertidora de la angiotensina u opiáceos. Nota explicativa: Se permiten los medicamentos anteriores si se han recibido de manera estable desde al menos dos meses antes de la visita de selección.
    Pacientes en tratamiento con mucolíticos, antihistamínicos, expectorantes o antitusígenos, incluidos los de venta sin receta.
    9. Pacientes que no mantengan unos ciclos regulares de día/noche o vigilia/sueño, por ejemplo, trabajadores en turnos nocturnos.
    Nota explicativa: Se excluirá a los pacientes con apnea del sueño sintomática, cualquier enfermedad relacionada con trastornos del sueño, como el síndrome de las piernas inquietas o sonambulismo. Sin embargo, el uso de presión positiva continua en las vías respiratorias no constituye un criterio de exclusión.
    10. Pacientes con alteraciones clínicamente importantes en los resultados de la exploración física en la visita 1 (selección).
    11. Pacientes con antecedentes de reacciones de hipersensibilidad (incluido el broncoespasmo paradójico) a agentes inhalatorios anticolinérgicos, aminas simpaticomiméticas o medicación inhalada o a cualquiera de sus componentes.
    12. Pacientes con diagnóstico de glaucoma de ángulo estrecho, obstrucción sintomática del cuello vesical, retención urinaria aguda o hipertrofia prostática sintomática inestable. Nota explicativa: No se excluye a los pacientes con hipertrofia prostática benigna asintomática, bien controlada y estable.
    13. Pacientes con antecedentes de infección no controlada por el virus de la inmunodeficiencia humana y/o hepatitis activa.
    Nota explicativa: Se define como hepatitis activa la presencia de síntomas clínicos asociados a inflamación portal crónica con necrosis y fibrosis regionales, que puede evolucionar a cirrosis nodular posnecrótica, o pacientes con resultados positivos en las pruebas de anticuerpos contra el antígeno central de la hepatitis B (anti-HBc) y antígeno de superficie de la hepatitis B (HBsAg), o con resultados positivos en las pruebas de anticuerpos contra el virus de la hepatitis C e inmunotransferencia recombinante (RIBA) del virus de la hepatitis C, o con resultados positivos en las pruebas de material genético (RNA).
    14. Diagnóstico actual de cáncer distinto del carcinoma cutáneo basocelular o espinocelular.
    15. Pacientes con cualquier otra disfunción física o mental grave o no controlada. Nota explicativa: A juicio del investigador, la disfunción podría suponer un mayor riesgo para el paciente como consecuencia de su participación en el estudio, podría ejercer un efecto de confusión en los resultados del estudio o sería probable que impidiera al paciente cumplir los requisitos del estudio o completarlo (por ejemplo, ideación suicida, trastornos del estado de ánimo, antecedentes personales de sobredosis).
    16. Pacientes con antecedentes (en los 2 años anteriores a la visita de selección) de drogadicción y/o alcoholismo que, a juicio del investigador, pudieran impedir el cumplimiento del estudio.
    17. Pacientes con pocas probabilidades de colaborar o que no puedan cumplir los procedimientos del estudio.
    Nota explicativa: Pacientes que puedan tener dificultades para seguir el tratamiento, cumplimentar los diarios del paciente o acudir a consulta en los momentos requeridos, o ser incapaces de utilizar correctamente un inhalador DPI o pMDI.
    18. Pacientes tratados con cualquier fármaco en investigación en el plazo de los 30 días (o 6 semividas, eligiéndose el mayor de estos plazos) anteriores a la visita 1 (selección).
    19. Pacientes con intención de utilizar algún medicamento concomitante no permitido por este protocolo o que no hayan pasado el periodo de estabilización requerido para la medicación prohibida.
    20. Cualquier otra circunstancia que, en opinión del investigador, pudiera indicar que el paciente no es adecuado para el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    - Change from baseline in Overall E-RS Total score (i.e. score over the whole 8 weeks study period)
    Criterio principal de valoración de la eficacia:
    - Cambio respecto al valor basal de la puntuación total del E-RS global (es decir, puntuación a lo largo de todo el periodo de estudio de 8 semanas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    score over the whole 8 weeks study period
    puntuación a lo largo de todo el periodo de estudio de 8 semanas
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    - Change from baseline in Overall E-RS Cough and Sputum domain score.
    - Change from baseline in the LCQ Total score at Week 8.
    Criterios secundarios de valoración de la eficacia:
    - Cambio respecto al valor basal de la puntuación de los dominios de tos y expectoración del E-RS global.
    - Cambio respecto al valor basal de la puntuación total del LCQ en la semana 8.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints:
    - at Week 8
    Criterio de valoración de seguridad secundario:
    - a la semana 8
    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. 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 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 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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Última visita del último paciente
    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 months9
    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 months9
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    After last study procedure is performed at Visit 4, subjects should continue to take their usual medication, also allowed during the trial, and may resume other medications discontinued prior to trial enrolment (with investigator?s agreement).
    Después que se haya realizado el último procedimiento del estudio en la visita 4, los sujetos deberán continuar recibiendo su medicación habitual, permitida también durante el ensayo, y podrán reanudar otros medicamentos suspendidos antes de su inclusión en el ensayo (si el investigador lo estima adecuado).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-17
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