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

2026년 8월 28일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

350

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Trial Transparency Trial Transparency
  • 전화번호: 800-633-1610 option 6
  • 이메일: Contact-us@sanofi.com

연구 장소

  • 미국
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • 모병
        • IU Health Pulmonology & Critical Care Medicine
        • 연락하다:
        • 수석 연구원:
          • Marc Rovner, MD, MMM, CPE, FACP, FCCP
    • North Carolina
      • Durham, North Carolina, 미국, 27705
        • 모병
        • Duke
        • 연락하다:
        • 수석 연구원:
          • Matt McCravy, MD
    • Texas
      • North Richland Hills, Texas, 미국, 76180
        • 모병
        • The Lung & Sleep Institute of North Texas
        • 연락하다:
        • 수석 연구원:
          • Tamer Hudali, MD MPH

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

COPD patients who are newly referred to start dupilumab treatment

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Cohort 1: COPD participants prescribed dupilumab
350 COPD consented participants prescribed dupilumab with prospective data collection
의약품: Cohort 1: Dupilumab
medicine already approved by the FDA
다른 이름들:
  • 듀피젠트
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.
다른: Cohort 2: usual care only
Usual care that patients receive

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Participant Characteristics
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: End of study (24 months after the last participant is enrolled)
Insurance Provider
End of study (24 months after the last participant is enrolled)

2차 결과 측정

결과 측정
측정값 설명
기간
COPD Exacerbations
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 6일

기본 완료 (추정된)

2029년 6월 30일

연구 완료 (추정된)

2029년 11월 30일

연구 등록 날짜

최초 제출

2026년 5월 19일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 5월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 28일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pro00119059
  • SANOFI STUDY No: OBS21707 (기타 식별자: SANOFI)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

Study Duration

IPD 공유 액세스 기준

Qualified researchers

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다