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

27 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

350

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Trial Transparency Trial Transparency
  • Numero di telefono: 800-633-1610 option 6
  • Email: Contact-us@sanofi.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

COPD patients who are newly referred to start dupilumab treatment

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Altri nomi:
  • Dupixent
Cohort 2: Control COPD participants not prescribed dupilumab
750 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.
Altro: Cohort 2: usual care only
Usual care that patients receive

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant Characteristics
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: End of study (24 months after the last participant is enrolled)
Insurance Provider
End of study (24 months after the last participant is enrolled)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
COPD Exacerbations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sanofi

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 luglio 2026

Completamento primario (Stimato)

30 giugno 2029

Completamento dello studio (Stimato)

30 novembre 2029

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00119059
  • SANOFI STUDY No: OBS21707 (Altro identificatore: SANOFI)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Periodo di condivisione IPD

Study Duration

Criteri di accesso alla condivisione IPD

Qualified researchers

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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