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

28. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

350

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Trial Transparency Trial Transparency
  • Telefonnummer: 800-633-1610 option 6
  • E-Mail: Contact-us@sanofi.com

Studienorte

  • Vereinigte Staaten
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • Rekrutierung
        • IU Health Pulmonology & Critical Care Medicine
        • Kontakt:
        • Hauptermittler:
          • Marc Rovner, MD, MMM, CPE, FACP, FCCP
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27705
        • Rekrutierung
        • Duke
        • Kontakt:
        • Hauptermittler:
          • Matt McCravy, MD
    • Texas
      • North Richland Hills, Texas, Vereinigte Staaten, 76180
        • Rekrutierung
        • The Lung & Sleep Institute of North Texas
        • Kontakt:
        • Hauptermittler:
          • Tamer Hudali, MD MPH

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

COPD patients who are newly referred to start dupilumab treatment

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Cohort 1: COPD participants prescribed dupilumab
350 COPD consented participants prescribed dupilumab with prospective data collection
Arzneimittel: Cohort 1: Dupilumab
medicine already approved by the FDA
Andere Namen:
  • Doppelt
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.
Sonstiges: Cohort 2: usual care only
Usual care that patients receive

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant Characteristics
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: End of study (24 months after the last participant is enrolled)
Insurance Provider
End of study (24 months after the last participant is enrolled)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
COPD Exacerbations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sanofi

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. August 2026

Primärer Abschluss (Geschätzt)

30. Juni 2029

Studienabschluss (Geschätzt)

30. November 2029

Studienanmeldedaten

Zuerst eingereicht

19. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

29. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Pro00119059
  • SANOFI STUDY No: OBS21707 (Andere Kennung: SANOFI)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

Study Duration

IPD-Sharing-Zugriffskriterien

Qualified researchers

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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