此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2016年11月20日 更新者: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).

研究概览

研究类型

介入性

注册 (实际的)

646

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

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

有资格学习的性别

全部

描述

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

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
安慰剂比较:安慰剂
匹配安慰剂
匹配安慰剂
实验性的:fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
Inhaled corticosteroid/long acting beta-agonist

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
Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168
大体时间: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

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。

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。

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

2011年4月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2011年6月9日

首先提交符合 QC 标准的

2011年6月16日

首次发布 (估计)

2011年6月20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20日

最后验证

2016年11月1日

更多信息

与本研究相关的术语

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. 统计分析计划
    信息标识符:113684
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  2. 带注释的病例报告表
    信息标识符:113684
    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:113684
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  4. 临床研究报告
    信息标识符:113684
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  5. 数据集规范
    信息标识符:113684
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register
  6. 研究协议
    信息标识符:113684
    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:113684
    信息评论:For additional information about this study please refer to the GSK Clinical Study Register

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.

安慰剂的临床试验

3
订阅