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

28 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

350

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Trial Transparency Trial Transparency
  • Número de teléfono: 800-633-1610 option 6
  • Correo electrónico: Contact-us@sanofi.com

Ubicaciones de estudio

  • Estados Unidos
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Reclutamiento
        • IU Health Pulmonology & Critical Care Medicine
        • Contacto:
        • Investigador principal:
          • Marc Rovner, MD, MMM, CPE, FACP, FCCP
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Reclutamiento
        • Duke
        • Contacto:
        • Investigador principal:
          • Matt McCravy, MD
    • Texas
      • North Richland Hills, Texas, Estados Unidos, 76180
        • Reclutamiento
        • The Lung & Sleep Institute of North Texas
        • Contacto:
        • Investigador principal:
          • Tamer Hudali, MD MPH

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

COPD patients who are newly referred to start dupilumab treatment

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Cohort 1: COPD participants prescribed dupilumab
350 COPD consented participants prescribed dupilumab with prospective data collection
Droga: Cohort 1: Dupilumab
medicine already approved by the FDA
Otros nombres:
  • Dupixent
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.
Otro: Cohort 2: usual care only
Usual care that patients receive

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant Characteristics
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: End of study (24 months after the last participant is enrolled)
Insurance Provider
End of study (24 months after the last participant is enrolled)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
COPD Exacerbations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de agosto de 2026

Finalización primaria (Estimado)

30 de junio de 2029

Finalización del estudio (Estimado)

30 de noviembre de 2029

Fechas de registro del estudio

Enviado por primera vez

19 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Pro00119059
  • SANOFI STUDY No: OBS21707 (Otro identificador: SANOFI)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

Study Duration

Criterios de acceso compartido de IPD

Qualified researchers

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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