NCT07612878

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Jul 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

May 19, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

COPDDupilumabDupixentChronic Obstructive Pulmonary DiseaseExacerbationHome Spirometry

Outcome Measures

Primary Outcomes (16)

  • Participant Characteristics

    Age

    End of study (24 months after the last participant is enrolled)

  • Participant Characteristics

    Sex

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Height in meters

    End of study (24 months after the last participant is enrolled)

  • Participant Characteristics

    Weight in kilograms

    End of study (24 months after the last participant is enrolled)

  • Patients Characteristics

    BMI in kg/m\^2

    End of study (24 months after the last participant is enrolled)

  • Patients Characteristics

    Smoking and cannabis status/type/history

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Medical History

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Baseline disease characteristics

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Emphysema status

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Disease severity

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Eosinophil value

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    COPD-relevant vaccination status

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Prior and current medications

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Previous and current comorbidities

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Reason(s) for initiation of dupilumab treatment

    End of study (24 months after the last participant is enrolled)

  • Patient Characteristics

    Insurance Provider

    End of study (24 months after the last participant is enrolled)

Secondary Outcomes (9)

  • COPD Exacerbations

    End of Study (24 months after the last participant is enrolled)

  • FEV changes

    End of study (2 years after the last participant is enrolled)

  • Changes in Quality of Life

    End of study (2 years after the last participant is enrolled)

  • Events

    End of study (2 years after the last participant is enrolled)

  • COPD Exacerbations

    End of study (24 months after the last participant is enrolled)

  • +4 more secondary outcomes

Study Arms (2)

Cohort 1: COPD participants prescribed dupilumab

350 COPD consented participants prescribed dupilumab with prospective data collection

Drug: Cohort 1: Dupilumab

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.

Other: Cohort 2: usual care only

Interventions

medicine already approved by the FDA

Also known as: Dupixent
Cohort 1: COPD participants prescribed dupilumab

Usual care that patients receive

Cohort 2: Control COPD participants not prescribed dupilumab

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients who are newly referred to start dupilumab treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Trial Transparency Trial Transparency

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 29, 2026

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Study Duration
Access Criteria
Qualified researchers
More information