Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD

20 de noviembre de 2016 actualizado por: GlaxoSmithKline

A 24-week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder Delivered Once Daily Via a Dry Powder Inhaler Compared With Placebo in Subjects of Asian Ancestry With Chronic Obstructive Pulmonary Disease

The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

646

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Corea, república de
      • Seoul, Corea, república de, 158-710
        • GSK Investigational Site
      • Suwon, Gyeonggi-do, Corea, república de, 442-723
        • GSK Investigational Site
      • jeonju-si, Jeollabuk-Do, Corea, república de, 561-712
        • GSK Investigational Site
  • Filipinas
      • Quezon City, Filipinas, 1100
        • GSK Investigational Site
      • Quezon City, Filipinas, 1109
        • GSK Investigational Site
  • Porcelana
      • Beijing, Porcelana, 100034
        • GSK Investigational Site
      • Beijing, Porcelana, 100191
        • GSK Investigational Site
      • Beijing, Porcelana, 100020
        • GSK Investigational Site
      • Beijing, Porcelana, 100048
        • GSK Investigational Site
      • Changsha, Porcelana, 410013
        • GSK Investigational Site
      • Chengdu, Porcelana, 610041
        • GSK Investigational Site
      • Chongqing, Porcelana, 400038
        • GSK Investigational Site
      • Chongqing, Porcelana, 400037
        • GSK Investigational Site
      • Shanghai, Porcelana, 200025
        • GSK Investigational Site
      • Shanghai, Porcelana, 200433
        • GSK Investigational Site
      • Shanghai, Porcelana, 200080
        • GSK Investigational Site
      • Tianjin, Porcelana, 300052
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510515
        • GSK Investigational Site
      • Guangzhou, Guangdong, Porcelana, 510120
        • GSK Investigational Site
    • Guangxi
      • Nanning, Guangxi, Porcelana, 530021
        • GSK Investigational Site
    • Hunan
      • Changsha, Hunan, Porcelana, 410011
        • GSK Investigational Site
    • Liaoning
      • Shenyang, Liaoning, Porcelana, 110015
        • GSK Investigational Site
      • Shenyang, Liaoning, Porcelana, 110001
        • GSK Investigational Site
    • Shaanxi
      • Xian, Shaanxi, Porcelana, 710032
        • GSK Investigational Site
      • Xian, Shaanxi, Porcelana, 710061
        • GSK Investigational Site
    • Zhejiang
      • Hang Zhou, Zhejiang, Porcelana, 310003
        • GSK Investigational Site
  • Taiwán
      • Changhua, Taiwán, 500
        • GSK Investigational Site
      • Kaohsiung, Taiwán, 833
        • GSK Investigational Site
      • Taichung, Taiwán, 404
        • GSK Investigational Site
      • Taichung, Taiwán, 40705
        • GSK Investigational Site
      • Taichung, Taiwán, 40201
        • GSK Investigational Site
      • Taipei, Taiwán, 100
        • GSK Investigational Site
      • Taipei, Taiwán, 112
        • GSK Investigational Site
      • Tau-Yuan County, Taiwán, 333
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • COPD diagnosis define by ATS(American Thoracic Society)/ ERS (European Respiratory Society)
  • Subjects of Asian ancestry
  • Valid informed consent
  • Current or former smoker
  • > or = 2 on the modified Medical Research Council Dyspnea Scale at Screening

Exclusion Criteria:

  • Pregnancy
  • A current diagnosis of asthma
  • alpha1-antitrypsin deficiency as the underlying cause for COPD
  • Other active, respiratory disorders
  • Have lung volume reduction surgery within 12 months prior to Screening
  • A chest X-ray or CT (Computerised Tomography) scan reveals evidence of clinical significant abnormalities not believed to be due to the presence of COPD
  • Poorly controlled COPD: acute worsening of COPD managed by corticosteroids, antibiotics, or treatments prescribed by a physician 6 weeks prior to Screening, or requires hospitalisation due to poorly controlled COPD 12 weeks prior to Screening
  • Lower respiratory tract infection requires antibiotics within 4 weeks prior to Screening
  • Other disease or abnormalities, in the opinion of the investigator, would put the safety of the subject at risk during the study or would affect safety or efficacy analysis if the disease/condition exacerbated during the study
  • Subject with carcinoma that has not been in complete remission for at least 5 years, carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
  • Subject has a history of hypersensitivity to any of the study medications or components of the inhalation powder. Subject has a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation will also be excluded.
  • Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening
  • Subjects who are medically unable to withhold albuterol, ipratropium for 4 hrs and/or theophylline for 12 hrs prior to spirometry testing.
  • Subjects use a list of prohibited medications specified in the study protocol, including but not limited to traditional or herbal medications for the treatment of COPD
  • Subject requires long-term oxygen therapy or nocturnal oxygen therapy for greater than 12 hours a day
  • Pulmonary rehabilitation: subjects who are in the maintenance phase are not excluded.
  • Non-compliance
  • Questionable validity of the Informed Consent
  • Prior use of study medication or other investigational drugs
  • Affiliation with investigator site

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: placebo
placebo coincidente
Droga: Placebo
placebo coincidente
Experimental: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
Droga: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
Periodo de tiempo: Baseline to Day 169
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.
Baseline to Day 169

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168
Periodo de tiempo: Baseline (BL) and Day 168
CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.
Baseline (BL) and Day 168

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2011

Finalización primaria (Actual)

1 de septiembre de 2012

Finalización del estudio (Actual)

1 de septiembre de 2012

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2011

Publicado por primera vez (Estimar)

20 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

20 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 113684

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Datos del estudio/Documentos

  1. Plan de Análisis Estadístico
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulario de informe de caso anotado
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulario de consentimiento informado
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informe de estudio clínico
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  5. Especificación del conjunto de datos
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocolo de estudio
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
  7. Conjunto de datos de participantes individuales
    Identificador de información: 113684
    Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir