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    Summary
    EudraCT Number:2012-000524-18
    Sponsor's Protocol Code Number:DB2116134
    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:2012-12-21
    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 number2012-000524-18
    A.3Full title of the trial
    A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD
    Estudio multicéntrico, aleatorizado, doble ciego, de doble enmascaramiento, de grupos paralelos, para evaluar la eficacia y seguridad de Umeclidinium/ Vilanterol comparado con Propionato de fluticasona/Salmeterol, durante 12 semanas, en sujetos con EPOC.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare umeclidinium/vilanterol compared with fluticasone propionate/salmeterol in COPD
    Estudio para evaluar Umeclidinium/ Vilanterol comparado con Propionato de fluticasona/Salmeterol en la EPOC.
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberDB2116134
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGSK Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44208990 4466
    B.5.5Fax number44208990 4466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameUmeclidinium bromide/vilanterol
    D.3.2Product code GSK573719/GW642444
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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.3.8INN - Proposed INNUmeclidinium bromide
    D.3.9.1CAS number 869113-09-7
    D.3.9.2Current sponsor codeGSK573719
    D.3.9.4EV Substance CodeSUB31865
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVILANTEROL
    D.3.9.1CAS number 503068-34-6
    D.3.9.2Current sponsor codeGW642444
    D.3.9.4EV Substance CodeSUB30696
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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 Seretide®
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Wellcome UK Limited
    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 namefluticasone propionate/salmeterol
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    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.3.8INN - Proposed INNfluticasone propionate
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL
    D.3.9.1CAS number 89365-50-4
    D.3.9.4EV Substance CodeSUB10430MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboInhalation powder, pre-dispensed
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation powder, pre-dispensed
    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
    Chronic Obstructive Pulmonary Disease (COPD) which may also be called emphysema or chronic bronchitis.
    Enfermedad Pulmonar Obstructiva Crónica (EPOC) que puede llamarse enfisema o bronquitis crónica.
    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 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
    Compare the efficacy and safety of UMEC/VI Inhalation Powder (62.5/25mcg once daily) with fluticasone propionate/salmeterol (500/50mcg twice-daily) over 12 weeks in subjects with COPD who have a history of infrequent COPD exacerbations
    Comparar la eficacia y seguridad de UMEC/VI polvo para inhalación (62,5/25 µg una vez al día) con propionato de fluticasona/salmeterol (500/50 µg dos veces al día) durante 12 semanas en sujetos con EPOC que tengan historia de exacerbaciones infrecuentes de la enfermedad
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type of subject: Outpatient
    2. Informed Consent: A signed and dated written informed consent prior to study participation
    3. Age: Subjects 40 years of age or older at Visit 1
    4. Gender: Male or female subjects.
    A female is eligible to enter and participate in the study if she is of:
    Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to
    one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study ? screening to follow-up contact):
    - Abstinence
    - Oral Contraceptive, either combined or progestogen alone
    - Injectable progestogen
    - Implants of levonorgestrel
    - Estrogenic vaginal ring
    - Percutaneous contraceptive patches
    - Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
    - Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee?s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject?s medical records.
    - Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent(foam/gel/film/cream/suppository)
    5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004] as follows:
    Chronic obstructive pulmonary disease is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
    Although COPD affects the lungs, it also produces significant systemic consequences.
    6. Smoking history: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day/20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar smoking cannot be used to calculate pack year history.
    7. Severity of disease: A pre and post-salbutamol FEV1/FVC ratio of <0.70 and a postsalbutamol FEV1 of >=30% and <=70% of predicted normal values calculated using NHANES III reference equations at Visit 1 [Hankinson, 1999; Hankinson, 2010].
    8. Dyspnea: A score of >=2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1.
    1. Tipo de sujeto: Ambulatorio.
    2. Consentimiento informado: Se ha de obtener el consentimiento informado por escrito antes de la participación en el estudio.
    3. Edad: Sujetos de 40 años de edad o mayores en la Visita 1.
    4. Sexo: Hombres o mujeres.
    Una mujer es elegible para participar en el estudio si:
    No es fértil (es decir, es fisiológicamente incapaz de quedarse embarazada, incluidas las mujeres posmenopáusicas o quirúrgicamente estériles). Las mujeres quirúrgicamente estériles se definen como aquellas que han sido sometidas a histerectomía, ooforectomía o ligadura de trompas bilateral documentadas. Las mujeres posmenopáusicas se definen como aquellas que tienen amenorrea de más de 1 año de duración con un perfil clínico apropiado, por ejemplo, edad apropiada, >45 años, en ausencia de tratamiento de sustitución hormonal.
    O
    Es fértil, tiene una prueba de embarazo negativa en la selección y está de acuerdo en utilizar uno de los siguientes métodos anticonceptivos aceptables de forma consistente y correcta (es decir, de acuerdo con la ficha técnica aprobada y las instrucciones del médico durante el estudio; desde la selección hasta el contacto de seguimiento):
    - Abstinencia
    - Anticonceptivo oral, combinado o progesterona sola
    - Progestágeno inyectable
    - Implantes de levonorgestrel
    - Anillo vaginal estrogénico
    - Parches anticonceptivos percutáneos
    - Dispositivo intrauterino (DIU) o sistema intrauterino (SIU) que cumpla los criterios de efectividad de los PNT según se establece en la etiqueta del producto
    - Esterilización del varón (vasectomía con documentación de azoospermia) antes de la inclusión de la mujer en el estudio y este varón debe ser la única pareja sexual de esa mujer. En esta definición, "documentada" se refiere al resultado de la exploración clínica del sujeto o la revisión de la historia clínica del sujeto para la elegibilidad para el estudio, obtenida a través de una entrevista con el sujeto o de sus informes médicos.
    - Método de doble barrera: preservativo y capuchón oclusivo (diafragma o capuchón cervical) con un espermicida (espuma/gel/película/crema/supositorio)
    5. Diagnóstico de EPOC: Historia clínica establecida de EPOC según la siguiente definición de la American Thoracic Society/European Respiratory Society [Celli, 2004]:
    La enfermedad pulmonar obstructiva crónica (EPOC) es una enfermedad que se puede prevenir y tratar, caracterizada por una obstrucción al flujo de aire que no es totalmente reversible. La obstrucción al flujo de aire suele ser progresiva y se asocia a una respuesta inflamatoria anormal de los pulmones a partículas o gases nocivos, causada principalmente por el humo del tabaco. Aunque la EPOC sfecta a los pulmones, también tiene consecuencias sistémicas significativas.
    6. Historia de fumador: Fumador actual o antiguo de >=10 paquete-años [número de paquete años = (número de cigarrillos al día / 20) x número de años de fumador (por ejemplo, 20 cigarrillos al día durante 10 años o 10 cigarrillos al día durante 20 años)]. Los fumadores antiguos se definen como aquellos que han dejado de fumar al menos 6 meses antes de la Visita 1. El tabaco de pipa o el cigarro puro no se pueden utilizar para calcular la historia de paquete-años.
    7. Gravedad de la enfermedad: Cociente VEMS/CVF pre y post-salbutamol <0,70 y VEMS post-salbutamol >=30% y <=70% del valor normal teórico calculado utilizando las ecuaciones de referencia NHANES III en la Visita 1 [Hankinson, 1999; Hankinson, 2010].
    8. Disnea: Una puntuación >=2 en la escala Modified Medical Research Council Dyspnea (mMRC) en la Visita 1.
    E.4Principal exclusion criteria
    1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
    2. Asthma: A current diagnosis of asthma
    3. Other Respiratory Disorders: Known ?-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject, who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Inactive tuberculosis in more than one lobe is exclusionary. Allergic rhinitis is not exclusionary.
    4. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through
    participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
    5. Contraindications: A history of allergy or hypersensitivity to any
    anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid, lactose/milk protein or magnesium stearate or a medical condition such as narrowangle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of a inhaled anticholinergic.
    6. Hospitalization: Hospitalization for pneumonia within 12 weeks prior to Visit 1
    7. History of COPD Exacerbation: A documented history of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics, and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence.
    8. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
    9. 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject eligibility are listed in Appendix 4 (Section 11.4). The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4.
    10. Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit
    11. Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1:
    (See Full Table in Protocol - Section 4.3; page 24)
    12. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ?12 hours per day) is not exclusionary.
    13. Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy.
    14. Pulmonary Rehabilitation Program: Participation in the acute phase of a
    pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
    15. Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
    16. Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating investigator
    17. Inability to read: A subject will not be eligible for the study if in the opinion of the investigator the subject cannot read.
    1. Embarazo: Mujeres en estado de gestación o lactancia o que tengan planeado quedarse embarazadas durante el estudio.
    2. Asma: Diagnóstico actual de asma.
    3. Otras enfermedades respiratorias: La deficiencia conocida de alfa-1 antitripsina, las infecciones pulmonares activas (como tuberculosis) y el cáncer de pulmón son condiciones excluyentes absolutas. Un sujeto que, a juicio del investigador, tenga cualquier otra enfermedad respiratoria significativa además de la EPOC, debe ser excluido. Son ejemplos: bronquiectasias clínicamente significativas, hipertensión pulmonar, sarcoidosis o enfermedad pulmonar intersticial. La tuberculosis inactiva que afecte a más de un lóbulo pulmonar es excluyente. La rinitis alérgica no es excluyente.
    4. Otras enfermedades/anomalías: Sujetos con evidencia antigua o actual de anomalías clínicamente significativas cardiovasculares, neurológicas, psiquiátricas, renales, hepáticas, inmunológicas, endocrinas (incluidas la diabetes no controlada o la enfermedad tiroidea) o hematológicas que estén incontroladas o historia anterior de cáncer en remisión <5 años antes de la Visita 1 (el carcinoma cutáneo localizado que ha sido totalmente extirpado no es excluyente). Significativa se define como cualquier enfermedad que a juicio del investigador pondría en riesgo la seguridad del sujeto si participara en el estudio o que afectaría al análisis de eficacia o seguridad si la enfermedad/anomalía se exacerbara durante el estudio.
    5. Contraindicaciones: Historia de alergia o hipersensibilidad a cualquier antagonista de los receptores anticolinérgicos/muscarínicos, beta2-agonista, corticosteroides, lactosa/proteínas de la leche o estearato de magnesio o una enfermedad como el glaucoma de ángulo cerrado, la hipertrofia prostática o la obstrucción del cuello de la vejiga que, a juicio del médico del estudio, contraindique la participación en el estudio o el empleo de anticolinérgicos inhalados.
    6. Hospitalización: Hospitalización por neumonía en las 12 semanas anteriores a la Visita 1.
    7. Historia de exacerbaciones de la EPOC: Historia documentada de al menos una exacerbación de la EPOC en los 12 meses anteriores a la Visita 1, que obligue a la administración de corticosteroides orales y antibióticos o a la hospitalización. Sólo el empleo anterior de antibióticos no se califica de historia de exacerbación a menos que el empleo se asocie al tratamiento de síntomas de empeoramiento de la EPOC como aumento de la disnea, volumen del esputo o purulencia del esputo.
    8. Resección pulmonar: Sujetos sometidos a cirugía reductora del volumen pulmonar en los 12 meses anteriores a la Selección (Visita 1).
    9. ECG de 12 derivaciones: Hallazgo ECG anormal y significativo en el ECG de 12 derivaciones realizado en la Visita 1. Se proporcionará a los investigadores revisiones realizadas por un cardiólogo independiente centralizado para ayudar en la evaluación de la elegibilidad del sujeto. Los hallazgos ECG que impiden la elegibilidad del sujeto se citan en el Apéndice 4 (Sección 11.4). El investigador del estudio determinará el significado médico de cualquier otra anomalía ECG no citada en el Apéndice 4.
    10. Medicación anterior a la espirometría: Sujeto incapaz de suspender el salbutamol al menis 4 horas antes de la espirometría en cada visita del estudio.
    11. Medicaciones anteriores a la Selección: Empleo de las siguientes medicaciones en los siguientes intervalos de tiempo anteriores a la Visita 1: (Ver la Tabla completa en el Protocolo: Apartado 4.3)
    12. Oxígeno: Empleo de oxigenoterapia prolongada (LTOT) descrita como oxigenoterapia prescrita durante más de 12 horas al día. El empleo de oxígeno a demanda (<=12 horas al día) no es excluyente.
    13. Terapia nebulizada: Empleo regular (prescrito para su uso todos los días, no a demanda) de broncodilatadores de acción corta (ej., salbutamol) a través de terapia nebulizada.
    14. Programa de rehabilitación pulmonar: Participación en la fase aguda de un programa de rehabilitación pulmonar en las 4 semanas anteriores a la Visita 1. Los sujetos que estén en la fase de mantenimiento de un programa de rehabilitación pulmonar no serán excluidos.
    15. Abuso de alcohol o drogas: Historia conocida o sospecha de abuso de alcohol o drogas en los 2 años anteriores a la Visita 1.
    16. Afiliación con el centro investigador: Un sujeto no será elegible para este estudio si es familiar directo del investigador, subinvestigador, coordinador del estudio o empleado de un centro investigador participante.
    17. Incapacidad para leer: Un sujeto no será elegible para el estudio si el investigador considera que el sujeto no puede leer.
    E.5 End points
    E.5.1Primary end point(s)
    24-hour weighted-mean serial FEV1
    Media ponderada del VEMS de 24 horas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On Treatment Day 84, the weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre evening dose), 13, 15, 18, 23, and 24 hours after the morning dose.
    El Día 84 de tratamiento, la media ponderada se calcula con el VEMS pre-dosis y el VEMS post-dosis medidos 5 y 15 minutos y 1, 3, 6, 9, 12 (antes de la dosis nocturna), 13, 15, 18, 23 y 24 horas después de la dosis matutina.
    E.5.2Secondary end point(s)
    Trough and Weighted Mean FEV1
    Rescue salbutamol use (percentage of rescue-free days and puffs/day)
    Proportion of subjects achieving an increase in FEV1 of ?12% and ?200mL above baseline
    Proportion of subjects achieving an increase of ?100mL above baseline in trough FEV1
    Peak and serial FEV1
    Serial, trough and weighted mean FVC
    TDI focal score
    Incidence of adverse events (AEs)
    COPD exacerbations
    Vital signs
    EQ-5D health outcome assessment
    COPD Assessment Test (CAT)
    St. George?s Respiratory Questionnaire for COPD patients (SGRQ-C)
    - VEMS valle y media ponderada del VEMS.
    - Empleo de salbutamol de rescate (porcentaje de días sin rescate e inhalaciones/día)
    - Proporción de sujetos que alcanzan un incremento del VEMS >=12% y ?200 mL por encima del valor basal.
    - Proporción de sujetos que alcanzan un incremento ?100 mL por encima del valor basal en el VEMS valle.
    - VEMS máximo
    - VEMS seriado, valle y media ponderada
    - Puntuación del TDI
    - Incidencia de acontecimientos adversos (AA)
    - Exacerbaciones de la EPOC
    - Constantes vitales
    - EQ-5D
    - Prueba de evaluación de la EPOC (CAT)
    - St. George?s Respiratory Questionnaire para pacientes con EPOC (SGRQ-C)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weighted Mean FEV1 and FVC over 0-6 hours post-dose on Day 1 and day 84
    Trough FEV1 and FVC at Day 28, Day 56, Day 84 and 85
    Rescue salbutamol use
    Proportion of subjects achieving an increase in FEV1 of ?12% and ?200mL above baseline at any time during 0-6 hours post-dose on Treatment Day 1
    Proportion of subjects achieving an increase of ?100mL above baseline in trough FEV1
    Peak FEV1
    Serial FEV1 and FVC over 0 to 6 hours post-dose on Day 1 and over 0 to 24 hours post-dose on Day 84
    Weighted mean FVC over 0-24 hours post-dose on Day 84
    - Media ponderada de la CVF durante 0-6 horas después de la dosis los Días 1 y 84.
    - VEMS y CVF valle los Días 28, 56, 84 y 85
    - Empleo de salbutamol de rescate
    - Proporción de sujetos que alcanzan un incremento del VEMS ?12% y ?200 mL por encima del valor basal en cualquier momento durante 0-6 horas después de la dosis el Día 1 de tratamiento.
    - Proporción de sujetos que alcanzan un incremento ?100 mL por encima del valor basal en el VEMS valle.
    - VEMS máximo
    - VEMS y CVF seriado durante 0-6 horas después de la dosis el Día 1 y durante 0-24 horas después de la dosis el Día 84.
    - Media ponderada de la CVF durante 0-24 horas después de la dosis el Día 84
    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 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) 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 Yes
    E.8.2.3.1Comparator description
    fluticasone propionate/salmeterol
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Denmark
    Germany
    Hungary
    Netherlands
    Poland
    Russian Federation
    Spain
    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 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 months6
    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 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 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: 710
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 710
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 508
    F.4.2.2In the whole clinical trial 710
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the patient?s medical condition whether or not GSK is providing specific post study treatment.
    GSK will not provide post-study treatment. There are no plans to provide study
    medication for compassionate use following study completion. At the end of the treatment period (Visit 5 or Early Withdrawal), subjects can resume conventional COPD therapy as prescribed by the investigator.
    El investigador es responsable de garantizar que el sujeto recibe los cuidados posteriores al estudio necesarios para su enfermedad con independencia de que GSK proporcione o no un tto. específico posterior al estudio. GSK no proporcionará tto. posterior al estudio. No se prevé proporcionar medicación del estudio para uso compasivo después de terminar el estudio. Al final del periodo de tto., los sujetos pueden reanudar la terapia convencional para la EPOC bajo prescripción del investigador.
    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 Decision2013-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
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