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A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD

2016年11月23日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

187

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 日本
      • Fukuoka、日本、811-2201
        • GSK Investigational Site
      • Fukuoka、日本、819-8555
        • GSK Investigational Site
      • Fukushima、日本、964-0871
        • GSK Investigational Site
      • Gunma、日本、371-0048
        • GSK Investigational Site
      • Hiroshima、日本、732-0057
        • GSK Investigational Site
      • Hokkaido、日本、001-0901
        • GSK Investigational Site
      • Hokkaido、日本、064-0915
        • GSK Investigational Site
      • Hokkaido、日本、070-8644
        • GSK Investigational Site
      • Hyogo、日本、651-0073
        • GSK Investigational Site
      • Ibaraki、日本、300-0053
        • GSK Investigational Site
      • Ibaraki、日本、310-0015
        • GSK Investigational Site
      • Ishikawa、日本、920-8610
        • GSK Investigational Site
      • Kagawa、日本、760-0073
        • GSK Investigational Site
      • Kagawa、日本、763-8502
        • GSK Investigational Site
      • Kanagawa、日本、239-0821
        • GSK Investigational Site
      • Kyoto、日本、601-1495
        • GSK Investigational Site
      • Kyoto、日本、615-8087
        • GSK Investigational Site
      • Miyagi、日本、981-8563
        • GSK Investigational Site
      • Miyagi、日本、984-8560
        • GSK Investigational Site
      • Nagano、日本、390-0303
        • GSK Investigational Site
      • Nagano、日本、390-0832
        • GSK Investigational Site
      • Nagano、日本、390-8601
        • GSK Investigational Site
      • Nagano、日本、391-0011
        • GSK Investigational Site
      • Oita、日本、870-0921
        • GSK Investigational Site
      • Oita、日本、876-0047
        • GSK Investigational Site
      • Okayama、日本、701-0304
        • GSK Investigational Site
      • Osaka、日本、545-8586
        • GSK Investigational Site
      • Osaka、日本、530-0012
        • GSK Investigational Site
      • Osaka、日本、576-0016
        • GSK Investigational Site
      • Osaka、日本、589-0022
        • GSK Investigational Site
      • Tokyo、日本、185-0014
        • GSK Investigational Site
      • Tokyo、日本、187-0024
        • GSK Investigational Site
      • Toyama、日本、930-0194
        • GSK Investigational Site
      • Wakayama、日本、641-8510
        • GSK Investigational Site
      • Yamanashi、日本、400-0031
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
药品：Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
实验性的：Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
药品：Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
大体时间：From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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.
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
大体时间：From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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.
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Pneumonia During the Treatment Period
大体时间：From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
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
From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
大体时间：Baseline (Week -2), and Week 52/Withdrawal (WD)
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.
Baseline (Week -2), and Week 52/Withdrawal (WD)
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)
大体时间：Baseline (Week -2), and Week 52/Withdrawal (WD
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.
Baseline (Week -2), and Week 52/Withdrawal (WD
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
大体时间：Baseline (Week -2), Week 52/Withdrawal (WD)
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.
Baseline (Week -2), Week 52/Withdrawal (WD)
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
大体时间：Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
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.
Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
大体时间：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
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.
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
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
大体时间：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
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.
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
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
大体时间：Baseline (Week -2), Week 12, Week 24, and Week 52
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.
Baseline (Week -2), Week 12, Week 24, and Week 52

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2012年1月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2010年8月30日

首先提交符合 QC 标准的

2010年8月30日

首次发布 (估计)

2010年8月31日

研究记录更新

最后更新发布 (估计)

2017年1月11日

上次提交的符合 QC 标准的更新

2016年11月23日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 114156

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

研究数据/文件

  1. 临床研究报告
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 研究协议
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 知情同意书
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  4. 带注释的病例报告表
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 统计分析计划
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 数据集规范
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  7. 个人参与者数据集
    信息标识符：114156
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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