A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
23 de novembro de 2016 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
187
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Fukuoka, Japão, 811-2201
- GSK Investigational Site
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Fukuoka, Japão, 819-8555
- GSK Investigational Site
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Fukushima, Japão, 964-0871
- GSK Investigational Site
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Gunma, Japão, 371-0048
- GSK Investigational Site
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Hiroshima, Japão, 732-0057
- GSK Investigational Site
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Hokkaido, Japão, 001-0901
- GSK Investigational Site
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Hokkaido, Japão, 064-0915
- GSK Investigational Site
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Hokkaido, Japão, 070-8644
- GSK Investigational Site
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Hyogo, Japão, 651-0073
- GSK Investigational Site
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Ibaraki, Japão, 300-0053
- GSK Investigational Site
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Ibaraki, Japão, 310-0015
- GSK Investigational Site
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Ishikawa, Japão, 920-8610
- GSK Investigational Site
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Kagawa, Japão, 760-0073
- GSK Investigational Site
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Kagawa, Japão, 763-8502
- GSK Investigational Site
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Kanagawa, Japão, 239-0821
- GSK Investigational Site
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Kyoto, Japão, 601-1495
- GSK Investigational Site
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Kyoto, Japão, 615-8087
- GSK Investigational Site
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Miyagi, Japão, 981-8563
- GSK Investigational Site
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Miyagi, Japão, 984-8560
- GSK Investigational Site
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Nagano, Japão, 390-0303
- GSK Investigational Site
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Nagano, Japão, 390-0832
- GSK Investigational Site
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Nagano, Japão, 390-8601
- GSK Investigational Site
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Nagano, Japão, 391-0011
- GSK Investigational Site
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Oita, Japão, 870-0921
- GSK Investigational Site
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Oita, Japão, 876-0047
- GSK Investigational Site
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Okayama, Japão, 701-0304
- GSK Investigational Site
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Osaka, Japão, 545-8586
- GSK Investigational Site
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Osaka, Japão, 530-0012
- GSK Investigational Site
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Osaka, Japão, 576-0016
- GSK Investigational Site
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Osaka, Japão, 589-0022
- GSK Investigational Site
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Tokyo, Japão, 185-0014
- GSK Investigational Site
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Tokyo, Japão, 187-0024
- GSK Investigational Site
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Toyama, Japão, 930-0194
- GSK Investigational Site
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Wakayama, Japão, 641-8510
- GSK Investigational Site
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Yamanashi, Japão, 400-0031
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Pneumonia During the Treatment Period
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2010
Conclusão Primária (Real)
1 de janeiro de 2012
Conclusão do estudo (Real)
1 de janeiro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
30 de agosto de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de agosto de 2010
Primeira postagem (Estimativa)
31 de agosto de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de janeiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de novembro de 2016
Última verificação
1 de novembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Doenças Pulmonares Obstrutivas
- Doenças pulmonares
- Doença Pulmonar Obstrutiva Crônica
- Efeitos Fisiológicos das Drogas
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Antiinflamatórios
- Agentes dermatológicos
- Agentes broncodilatadores
- Agentes Antiasmáticos
- Agentes do Sistema Respiratório
- Agentes Antialérgicos
- Fluticasona
- Xhance
Outros números de identificação do estudo
- 114156
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dados/documentos do estudo
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Relatório de Estudo Clínico
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudo
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Formulário de Consentimento Informado
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Formulário de Relato de Caso Anotado
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Plano de Análise Estatística
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Especificação do conjunto de dados
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
-
Conjunto de dados de participantes individuais
Identificador de informação: 114156Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .