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The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry (STRIDE)

2026年8月28日 更新者：Sanofi
The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and/or severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This registry will enroll 350 participants with COPD newly initiated in dupilumab over a period of approximately 12 months at approximately 20 US sites experienced in the diagnosis and treatment of COPD. Data, chest images, and home spirometries will be collected from participants for approximately 2 years. Participant management and treatment decisions will be determined by participants and their health care professionals.

研究类型

观察性的

注册 (估计的)

350

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。

学习联系方式

  • 姓名：Trial Transparency Trial Transparency
  • 电话号码：800-633-1610 option 6
  • 邮箱：Contact-us@sanofi.com

学习地点

  • 美国
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • IU Health Pulmonology & Critical Care Medicine
        • 接触：
        • 首席研究员：
          • Marc Rovner, MD, MMM, CPE, FACP, FCCP
    • North Carolina
      • Durham、North Carolina、美国、27705
        • 招聘中
        • Duke
        • 接触：
        • 首席研究员：
          • Matt McCravy, MD
    • Texas
      • North Richland Hills、Texas、美国、76180
        • 招聘中
        • The Lung & Sleep Institute of North Texas
        • 接触：
        • 首席研究员：
          • Tamer Hudali, MD MPH

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

COPD patients who are newly referred to start dupilumab treatment

描述

Inclusion Criteria:

  • COPD patients who are newly referred to start dupilumab treatment
  • Age ≥ 40 years
  • Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit

Exclusion Criteria:

  • Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)
  • Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments
  • Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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

队列和干预

团体/队列
干预/治疗
Cohort 1: COPD participants prescribed dupilumab
350 COPD consented participants prescribed dupilumab with prospective data collection
药品：Cohort 1: Dupilumab
medicine already approved by the FDA
其他名称：
  • 双色素
Cohort 2: Control COPD participants not prescribed dupilumab
700 COPD control participants from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. These participants will not be consented with retrospective data collection.
其他：Cohort 2: usual care only
Usual care that patients receive

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
Participant Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Age
End of study (24 months after the last participant is enrolled)
Participant Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Sex
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Height in meters
End of study (24 months after the last participant is enrolled)
Participant Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Weight in kilograms
End of study (24 months after the last participant is enrolled)
Patients Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
BMI in kg/m^2
End of study (24 months after the last participant is enrolled)
Patients Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Smoking and cannabis status/type/history
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Medical History
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Baseline disease characteristics
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Emphysema status
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Disease severity
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Eosinophil value
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
COPD-relevant vaccination status
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Prior and current medications
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Previous and current comorbidities
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Reason(s) for initiation of dupilumab treatment
End of study (24 months after the last participant is enrolled)
Patient Characteristics
大体时间：End of study (24 months after the last participant is enrolled)
Insurance Provider
End of study (24 months after the last participant is enrolled)

次要结果测量

结果测量
措施说明
大体时间
COPD Exacerbations
大体时间：End of Study (24 months after the last participant is enrolled)
(1a) Total number of moderate or severe COPD exacerbations in the 12 and 24 months after enrollment
End of Study (24 months after the last participant is enrolled)
FEV changes
大体时间：End of study (2 years after the last participant is enrolled)
Change from enrollment in FEV at 12 and 24 months after enrollment
End of study (2 years after the last participant is enrolled)
Changes in Quality of Life
大体时间：End of study (2 years after the last participant is enrolled)
(3a) Change from enrollment in St. George's Respiratory Questionnaire (SGRQ) Total Score at 12 and 24 months after enrollment. Minimum score is 0 and maximum score is 100. Higher scores indicate worse health status.
End of study (2 years after the last participant is enrolled)
Events
大体时间：End of study (2 years after the last participant is enrolled)
Major Adverse Cardiovascular Events (MACE), hospitalization, and all cause of death
End of study (2 years after the last participant is enrolled)
COPD Exacerbations
大体时间：End of study (24 months after the last participant is enrolled)
(1b) Total number of moderate COPD exacerbations in the 12 and 24 months after enrollment
End of study (24 months after the last participant is enrolled)
COPD Exacerbations
大体时间：End of study (24 months after the last participant is enrolled)
(1c) Total number of severe COPD exacerbations in the 12 and 24 months after enrollment
End of study (24 months after the last participant is enrolled)
Changes in Quality of Life
大体时间：End of study (2 years after the last participant is enrolled)
(3b) Change from enrollment in COPD Assessment Test (CAT), minimum score is 0, maximum score is 40. Higher scores mean worse health status. Total Score at 12 and 24 months after enrollment
End of study (2 years after the last participant is enrolled)
Changes in Quality of Life
大体时间：End of study (2 years after the last participant is enrolled)
(3c) Change from enrollment in Hospital Anxiety and Depression Scale (HADS) Score at 12 and 24 months after enrollment. Minimum score is 0, maximum score is 42. Lower scores mean better psycological well being.
End of study (2 years after the last participant is enrolled)
Changes in Quality of Life
大体时间：End of study (2 years after the last participant is enrolled)
(3d) Change from enrollment in mMRC-Dyspnea Score (mMRC-DS) Score, minimum score is 0, maximum score is4. Higher scores indicate worse health at 12 and 24 months after enrollment
End of study (2 years after the last participant is enrolled)

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

Sanofi

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)

2026年8月6日

初级完成 (估计的)

2029年6月30日

研究完成 (估计的)

2029年11月30日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年5月27日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年9月1日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8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

  • Pro00119059
  • SANOFI STUDY No: OBS21707 (其他标识符：SANOFI)

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

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

IPD 共享时间框架

Study Duration

IPD 共享访问标准

Qualified researchers

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

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

是的

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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