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A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)

2018年2月6日 更新者：Sunovion Respiratory Development Inc.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)

This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.

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, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011). The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29. Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).

研究类型

介入性

注册 (实际的)

275

阶段

  • 阶段2

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
    • Alabama
      • Jasper、Alabama、美国、35501
        • Jasper Summit Research, LLC
    • Arizona
      • Phoenix、Arizona、美国、85006
        • Pulmonary Associates, PA
    • California
      • Fullerton、California、美国、92835
        • California Research Medical Group, Inc.
      • Los Angeles、California、美国、90095
        • UCLA David Geffen School of Medicine
      • Riverside、California、美国、92506
        • Integrated Research Group
      • Sacramento、California、美国、95819
        • Capital Allergy & Respiratory Disease Center
      • San Diego、California、美国、92120
        • Institute of HealthCare Assessment, Inc.
    • Florida
      • Clearwater、Florida、美国、33765
        • Clinical Research of West Florida
      • Tampa、Florida、美国、33603
        • Clinical Research of West Florida
    • Georgia
      • Austell、Georgia、美国、30106
        • Georgia Clinical Research
      • Lawrenceville、Georgia、美国、30046
        • Gwinnett Biomedical Research
    • Kansas
      • Topeka、Kansas、美国、66606
        • Veritas Clinical Specialities, LTD
    • Minnesota
      • Minneapolis、Minnesota、美国、55407
        • Minnesota Lung Center
    • North Carolina
      • Charlotte、North Carolina、美国、28207
        • American Health Research
      • Raleigh、North Carolina、美国、27607
        • North Carolina Clinical Research
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • New Horizons Clinical Research
    • Oregon
      • Medford、Oregon、美国、97504
        • Clinical Research Institute of Southern Oregon, PC
      • Medford、Oregon、美国、97504
        • Sunstone Medical Research LLC
      • Portland、Oregon、美国、97202
        • Allergy Associates Research Center
    • South Carolina
      • Greenville、South Carolina、美国、29615
        • Upstate Pharmaceutical Research
      • Greenville、South Carolina、美国、29615
        • Greenville Pharmaceutical Research, Inc
      • Spartanburg、South Carolina、美国、29303
        • South Carolina Pharmaceutical Research
      • Union、South Carolina、美国、29379
        • CU Pharmacuetical Research
    • Texas
      • Houston、Texas、美国、77030
        • Baylor College of Medicine
      • New Braunfels、Texas、美国、78130
        • Central Texas Health Research
    • Virginia
      • Richmond、Virginia、美国、23225
        • Pulmonary Associates of Richmond, Inc.

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

35年 至 75年 (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:

  • Male and female subjects age 35 through 75 years, inclusive.
  • A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
  • Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
  • Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
  • Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

  • Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:

    • a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
    • b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
    • c. Abstinence.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
  • Current evidence or history of clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
  • Concomitant pulmonary disease or primary diagnosis of asthma.
  • History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin
  • Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
  • Use of daily oxygen therapy > 10 hours per day.
  • Use of systemic steroids within 3 months prior to the Screening Period.
  • Respiratory tract infection within 6 weeks prior to or during the Screening Period.
  • History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
  • History of urinary retention or bladder neck obstruction type symptoms.
  • History of narrow-angle glaucoma.
  • Prolonged QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
  • Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
  • History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
  • Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
  • Female subject who is pregnant or lactating

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：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
药品：Placebo
EP-101 Placebo AM + EP-101 Placebo PM
其他名称：
  • SUN101
实验性的：EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
药品：EP-101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
其他名称：
  • SUN101
实验性的：EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
药品：EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
其他名称：
  • SUN101
实验性的：EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
药品：EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
其他名称：
  • SUN101
实验性的：EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
药品：EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
其他名称：
  • SUN101

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 in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
大体时间：Baseline and Day 29
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).
Baseline and Day 29

次要结果测量

结果测量
措施说明
大体时间
The Standardized Change From Baseline FEV1 AUC(0-12)
大体时间：Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Standardized Change From Baseline FEV1 AUC(12-24)
大体时间：Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Day 28
The Peak FEV1 Change From Baseline
大体时间：Day 28
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.
Day 28
The Number of Subjects With Treatment-emergent Adverse Events
大体时间：Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Number of Subjects With Treatment-emergent Serious Adverse Events
大体时间：Baseline up to Day 28
Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
大体时间：Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Percentage of Subjects With Treatment-emergent Adverse Events
大体时间：Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Percentage of Subjects With Treatment-emergent Serious Adverse Events
大体时间：Baseline up to Day 28
Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28
The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
大体时间：Baseline up to Day 28
Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
Baseline up to Day 28

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

Sunovion Respiratory Development Inc.

调查人员

  • 研究主任：Respiratory Medical Director, MD、Sunovion Respiratory Development

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

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

2012年10月1日

初级完成 (实际的)

2013年4月1日

研究完成 (实际的)

2013年4月1日

研究注册日期

首次提交

2012年10月10日

首先提交符合 QC 标准的

2012年10月10日

首次发布 (估计)

2012年10月15日

研究记录更新

最后更新发布 (实际的)

2018年3月8日

上次提交的符合 QC 标准的更新

2018年2月6日

最后验证

2018年2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

  • EP-101-04 (SUN101)

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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