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A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

2018年8月2日 更新者：GlaxoSmithKline

A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week Treatment period. There will be a 7-day Follow-up period after the treatment period.

研究类型

介入性

注册 (实际的)

528

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

  • 乌克兰
      • Cherkassy、乌克兰、18009
        • GSK Investigational Site
      • Ivano-Frankivsk、乌克兰、76018
        • GSK Investigational Site
      • Kharkiv、乌克兰、61035
        • GSK Investigational Site
      • Kiev、乌克兰、03680
        • GSK Investigational Site
      • Kyiv、乌克兰、04107
        • GSK Investigational Site
  • 俄罗斯联邦
      • Chelyabinsk、俄罗斯联邦、454034
        • GSK Investigational Site
      • Kazan、俄罗斯联邦、420015
        • GSK Investigational Site
      • Kemerovo、俄罗斯联邦、650000
        • GSK Investigational Site
      • Moscow、俄罗斯联邦、115446
        • GSK Investigational Site
      • Moscow、俄罗斯联邦、125367
        • GSK Investigational Site
      • Moscow、俄罗斯联邦、115093
        • GSK Investigational Site
      • Yaroslavl、俄罗斯联邦、150003
        • GSK Investigational Site
  • 德国
      • Berlin、德国、14057
        • GSK Investigational Site
      • Berlin、德国、10117
        • GSK Investigational Site
      • Berlin、德国、10787
        • GSK Investigational Site
      • Berlin、德国、10789
        • GSK Investigational Site
      • Hamburg、德国、20253
        • GSK Investigational Site
    • Bayern
      • Muenchen、Bayern、德国、80809
        • GSK Investigational Site
    • Hessen
      • Frankfurt、Hessen、德国、60389
        • GSK Investigational Site
      • Frankfurt am Main、Hessen、德国、60596
        • GSK Investigational Site
    • Niedersachsen
      • Hannover、Niedersachsen、德国、30159
        • GSK Investigational Site
    • Sachsen
      • Delitzsch、Sachsen、德国、04509
        • GSK Investigational Site
      • Dresden、Sachsen、德国、01307
        • GSK Investigational Site
      • Leipzig、Sachsen、德国、04207
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg、Sachsen-Anhalt、德国、39112
        • GSK Investigational Site
  • 意大利
    • Campania
      • Benevento、Campania、意大利、82100
        • GSK Investigational Site
      • Salerno、Campania、意大利、84100
        • GSK Investigational Site
    • Lazio
      • Roma、Lazio、意大利、00135
        • GSK Investigational Site
    • Lombardia
      • Sesto S. Giovanni MI、Lombardia、意大利、20099
        • GSK Investigational Site
    • Puglia
      • Acquaviva Delle Fonti BA、Puglia、意大利、70021
        • GSK Investigational Site
    • Toscana
      • Pisa、Toscana、意大利、56124
        • GSK Investigational Site
    • Umbria
      • Perugia、Umbria、意大利、06156
        • GSK Investigational Site
    • Veneto
      • Cittadella PD、Veneto、意大利、35013
        • GSK Investigational Site
      • Verona、Veneto、意大利、37134
        • GSK Investigational Site
  • 比利时
      • Bouge、比利时、5004
        • GSK Investigational Site
      • Brussels、比利时、1200
        • GSK Investigational Site
      • Bruxelles、比利时、1070
        • GSK Investigational Site
      • Edegem、比利时、2650
        • GSK Investigational Site
      • Genk、比利时、3600
        • GSK Investigational Site
      • Gent、比利时、9000
        • GSK Investigational Site
      • Gilly、比利时、6060
        • GSK Investigational Site
  • 法国
      • Bethune Cedex、法国、62408
        • GSK Investigational Site
      • Brest Cedex、法国、29609
        • GSK Investigational Site
      • Lille、法国、59000
        • GSK Investigational Site
      • Marseille Cedex 20、法国、13915
        • GSK Investigational Site
      • Montpellier cedex 5、法国、34295
        • GSK Investigational Site
      • Nice、法国、06002
        • GSK Investigational Site
      • Pessac cedex、法国、33604
        • GSK Investigational Site
  • 波兰
      • Bialystok、波兰
        • GSK Investigational Site
      • Czestochowa、波兰、42-200
        • GSK Investigational Site
      • Lodz、波兰、93-329
        • GSK Investigational Site
      • Lodz、波兰、92-107
        • GSK Investigational Site
      • Ostrow Wielkopolski、波兰、63-400
        • GSK Investigational Site
      • Piekary Slaskie、波兰、41-940
        • GSK Investigational Site
      • Wilkowice、波兰、43-365
        • GSK Investigational Site
  • 菲律宾
      • Jaro, Iloilo City、菲律宾、5000
        • GSK Investigational Site
      • Lipa City、菲律宾、4217
        • GSK Investigational Site
      • Quezon City、菲律宾、1101
        • GSK Investigational Site
      • Quezon City、菲律宾、1100
        • GSK Investigational Site
  • 西班牙
      • Alicante、西班牙、03114
        • GSK Investigational Site
      • Barakaldo (Vizcaya)、西班牙、48903
        • GSK Investigational Site
      • Cáceres、西班牙、10003
        • GSK Investigational Site
      • Madrid、西班牙、28040
        • GSK Investigational Site
      • Pozuelo De Alarcón/Madrid、西班牙、28223
        • GSK Investigational Site
      • San Sebastián、西班牙、20014
        • GSK Investigational Site
      • Valencia、西班牙、46015
        • 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:

  • Signed and dated written informed consent
  • Male or females ≥ 40 years of age
  • Established clinical history of COPD by ATS/ERS definition
  • Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
  • Former or current smoker > 10 pack years
  • Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)
  • have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (Visit 1)

Exclusion Criteria:

  • Current diagnosis of asthma
  • Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
  • Lung volume reduction surgery within previous 12 months
  • Clinically significant abnormalities not due to COPD by chest x-ray
  • Hospitalized for poorly controlled COPD within 12 weeks of Screening
  • Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
  • Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
  • Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
  • Carcinoma not in complete remission for at least 5 years
  • Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
  • Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation - Known/suspected history of alcohol or drug abuse in the last 2 years
  • Women who are pregnant or lactating or plan to become pregnant
  • Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
  • Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study - Non-compliance or inability to comply with study procedures or scheduled visits
  • 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
实验性的：Fluticasone Furoate/Vilanterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
药品：Fluticasone Furoate 100mcg/Vilanterol 25mcg
Inhalation Powder
有源比较器：Fluticasone Propionate/Salmeterol
Inhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
药品：Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Inhalation Powder

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
Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84
大体时间：Baseline and Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
Baseline and Day 84

次要结果测量

结果测量
措施说明
大体时间
Time to Onset on Treatment Day 1
大体时间：Day 1
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.
Day 1
Change From Baseline in Trough FEV1 on Treatment Day 85
大体时间：Baseline and Day 85
Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.
Baseline and Day 85

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。

一般刊物

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

2011年2月1日

初级完成 (实际的)

2011年10月1日

研究完成 (实际的)

2011年10月19日

研究注册日期

首次提交

2011年4月14日

首先提交符合 QC 标准的

2011年4月26日

首次发布 (估计)

2011年4月27日

研究记录更新

最后更新发布 (实际的)

2018年8月31日

上次提交的符合 QC 标准的更新

2018年8月2日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 113107

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. 个人参与者数据集
    信息标识符：113107
    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：113107
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 统计分析计划
    信息标识符：113107
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  4. 数据集规范
    信息标识符：113107
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 临床研究报告
    信息标识符：113107
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 知情同意书
    信息标识符：113107
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  7. 研究协议
    信息标识符：113107
    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.

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