A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
23 de noviembre de 2016 actualizado por: GlaxoSmithKline
A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
187
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
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Fukuoka, Japón, 811-2201
- GSK Investigational Site
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Fukuoka, Japón, 819-8555
- GSK Investigational Site
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Fukushima, Japón, 964-0871
- GSK Investigational Site
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Gunma, Japón, 371-0048
- GSK Investigational Site
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Hiroshima, Japón, 732-0057
- GSK Investigational Site
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Hokkaido, Japón, 001-0901
- GSK Investigational Site
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Hokkaido, Japón, 064-0915
- GSK Investigational Site
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Hokkaido, Japón, 070-8644
- GSK Investigational Site
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Hyogo, Japón, 651-0073
- GSK Investigational Site
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Ibaraki, Japón, 300-0053
- GSK Investigational Site
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Ibaraki, Japón, 310-0015
- GSK Investigational Site
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Ishikawa, Japón, 920-8610
- GSK Investigational Site
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Kagawa, Japón, 760-0073
- GSK Investigational Site
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Kagawa, Japón, 763-8502
- GSK Investigational Site
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Kanagawa, Japón, 239-0821
- GSK Investigational Site
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Kyoto, Japón, 601-1495
- GSK Investigational Site
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Kyoto, Japón, 615-8087
- GSK Investigational Site
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Miyagi, Japón, 981-8563
- GSK Investigational Site
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Miyagi, Japón, 984-8560
- GSK Investigational Site
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Nagano, Japón, 390-0303
- GSK Investigational Site
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Nagano, Japón, 390-0832
- GSK Investigational Site
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Nagano, Japón, 390-8601
- GSK Investigational Site
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Nagano, Japón, 391-0011
- GSK Investigational Site
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Oita, Japón, 870-0921
- GSK Investigational Site
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Oita, Japón, 876-0047
- GSK Investigational Site
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Okayama, Japón, 701-0304
- GSK Investigational Site
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Osaka, Japón, 545-8586
- GSK Investigational Site
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Osaka, Japón, 530-0012
- GSK Investigational Site
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Osaka, Japón, 576-0016
- GSK Investigational Site
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Osaka, Japón, 589-0022
- GSK Investigational Site
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Tokyo, Japón, 185-0014
- GSK Investigational Site
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Tokyo, Japón, 187-0024
- GSK Investigational Site
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Toyama, Japón, 930-0194
- GSK Investigational Site
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Wakayama, Japón, 641-8510
- GSK Investigational Site
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Yamanashi, Japón, 400-0031
- GSK Investigational Site
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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:
- Out patient at least 40 years of age
- Both genders; females childbearing potencial must be willing to use birth control method
- A diagnosis of COPD at Screening
- Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
- Post-bronchodilator FEV1/FVC ratio of less than 70%
- Post-bronchodilator FEV1 of less than 80%
Exclusion Criteria:
- Current diagnosis of sthma
- Respiratory disorders other than COPD
- Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
- Concurrent other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during this study
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 |
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Experimental: Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
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Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
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Experimental: Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
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Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Periodo de tiempo: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.
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From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
Periodo de tiempo: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
Relatedness was assessed by the investigator.
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From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Pneumonia During the Treatment Period
Periodo de tiempo: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli.
All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot
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From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Periodo de tiempo: Baseline (Week -2), and Week 52/Withdrawal (WD)
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Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count).
Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.
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Baseline (Week -2), and Week 52/Withdrawal (WD)
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Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Periodo de tiempo: Baseline (Week -2), and Week 52/Withdrawal (WD
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Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA).
Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.
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Baseline (Week -2), and Week 52/Withdrawal (WD
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Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Periodo de tiempo: Baseline (Week -2), Week 52/Withdrawal (WD)
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Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC).
The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample.
The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample.
Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.
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Baseline (Week -2), Week 52/Withdrawal (WD)
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Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
Periodo de tiempo: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
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24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol.
Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
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Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
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Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Periodo de tiempo: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
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Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD.
Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes.
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
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Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
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Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Periodo de tiempo: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
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Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD).
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
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Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
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Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Periodo de tiempo: Baseline (Week -2), Week 12, Week 24, and Week 52
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A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52).
Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings.
Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.
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Baseline (Week -2), Week 12, Week 24, and Week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
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 agosto de 2010
Finalización primaria (Actual)
1 de enero de 2012
Finalización del estudio (Actual)
1 de enero de 2012
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2010
Primero enviado que cumplió con los criterios de control de calidad
30 de agosto de 2010
Publicado por primera vez (Estimar)
31 de agosto de 2010
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
23 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades Pulmonares Obstructivas
- Enfermedades pulmonares
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes antiinflamatorios
- Agentes dermatológicos
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Agentes antialérgicos
- Fluticasona
- Xhance
Otros números de identificación del estudio
- 114156
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
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Informe de estudio clínico
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de informe de caso anotado
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 114156Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .