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Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.

2018年3月27日 更新者：GlaxoSmithKline

A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol 50mcg Twice Daily Via DISKUS® Inhaler on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (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)

186

阶段

  • 第四阶段

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

  • 美国
    • California
      • Berkeley、California、美国、94705
        • GSK Investigational Site
      • Fullerton、California、美国、92835
        • GSK Investigational Site
      • Rancho Mirage、California、美国、92270
        • GSK Investigational Site
      • San Diego、California、美国、92103
        • GSK Investigational Site
      • Walnut Creek、California、美国、94598
        • GSK Investigational Site
    • Colorado
      • Fort Collins、Colorado、美国、80528
        • GSK Investigational Site
      • Wheat Ridge、Colorado、美国、80033
        • GSK Investigational Site
    • Connecticut
      • Hartford、Connecticut、美国、06105
        • GSK Investigational Site
    • Florida
      • Fort Lauderdale、Florida、美国、33316
        • GSK Investigational Site
      • Jacksonville、Florida、美国、32205
        • GSK Investigational Site
      • Sarasota、Florida、美国、34239
        • GSK Investigational Site
      • Tamarac、Florida、美国、33321
        • GSK Investigational Site
    • Georgia
      • Atlanta、Georgia、美国、30342
        • GSK Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60612
        • GSK Investigational Site
      • North Chicago、Illinois、美国、60064
        • GSK Investigational Site
    • Kansas
      • Wichita、Kansas、美国、67207
        • GSK Investigational Site
    • Massachusetts
      • Boston、Massachusetts、美国、02135
        • GSK Investigational Site
    • Michigan
      • Cadillac、Michigan、美国、49601
        • GSK Investigational Site
    • Missouri
      • Saint Charles、Missouri、美国、63301
        • GSK Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68124
        • GSK Investigational Site
    • New York
      • Bronxville、New York、美国、10708
        • GSK Investigational Site
    • North Carolina
      • Charlotte、North Carolina、美国、28207
        • GSK Investigational Site
    • Oregon
      • Portland、Oregon、美国、97213
        • GSK Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国、29406-7108
        • GSK Investigational Site
      • Greer、South Carolina、美国、29651
        • GSK Investigational Site
      • Simpsonville、South Carolina、美国、29681
        • GSK Investigational Site
      • Spartanburg、South Carolina、美国、29303
        • GSK Investigational Site
    • Tennessee
      • Kingsport、Tennessee、美国、37660
        • GSK Investigational Site
      • Milan、Tennessee、美国、38372
        • GSK Investigational Site
    • Texas
      • Corsicana、Texas、美国、75110
        • GSK Investigational Site
      • San Antonio、Texas、美国、78217
        • GSK Investigational Site
      • San Antonio、Texas、美国、78205
        • GSK Investigational Site
    • Virginia
      • Richmond、Virginia、美国、23249
        • GSK Investigational Site
      • Richmond、Virginia、美国、23225
        • GSK Investigational Site
    • Washington
      • Bellingham、Washington、美国、98226
        • GSK Investigational Site
      • Spokane、Washington、美国、99204
        • GSK Investigational Site
      • Spokane、Washington、美国、99202
        • 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:

  • Established clinical history of COPD.
  • Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.
  • Smoking history of at least 10 pack-years, where both current and former smokers will be eligible.
  • Must have at least one native, evaluable hip.

Exclusion criteria:

  • History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.

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：Salmeterol 50 mcg BID
Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.
药品：Salmeterol 50 mcg BID
Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
其他名称：
  • GR33343G
设备：DISKUS inhaler
Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
实验性的：Fluticasone Propionate/Salmeterol 250/50 mcg BID
Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
设备：DISKUS inhaler
Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.
药品：Fluticasone Propionate/Salmeterol 250/50 mcg BID
Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
其他名称：
  • CCI18781/GR33343G

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
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4
大体时间：Baseline and Week 26, 52, 78, 104, 130, and 156
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Baseline and Week 26, 52, 78, 104, 130, and 156

次要结果测量

结果测量
措施说明
大体时间
Percent Change From Baseline in BMD at the Total Hip
大体时间：Baseline and Week 26, 52, 78, 104, 130, and 156
BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value.
Baseline and Week 26, 52, 78, 104, 130, and 156

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

  • This study has not been published in the scientific literature.

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 (实际的)

2004年4月28日

初级完成 (实际的)

2007年9月6日

研究完成 (实际的)

2007年9月6日

研究注册日期

首次提交

2006年7月19日

首先提交符合 QC 标准的

2006年7月19日

首次发布 (估计)

2006年7月21日

研究记录更新

最后更新发布 (实际的)

2018年7月2日

上次提交的符合 QC 标准的更新

2018年3月27日

最后验证

2018年3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

  • SCO40041

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：SCO40041
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 知情同意书
    信息标识符：SCO40041
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 数据集规范
    信息标识符：SCO40041
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  4. 研究协议
    信息标识符：SCO40041
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 个人参与者数据集
    信息标识符：SCO40041
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 带注释的病例报告表
    信息标识符：SCO40041
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  7. 临床研究报告
    信息标识符：SCO40041
    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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条件

罕见疾病

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