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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Drug: Cohort 1: Dupilumab; Other: Cohort 2: usual care only

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Trial Transparency Trial Transparency; Phone Number: 800-633-1610 option 6; Email: Contact-us@sanofi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COPD patients who are newly referred to start dupilumab treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: COPD participants prescribed dupilumab; 350 COPD consented participants prescribed dupilumab with prospective data collection	Drug: Cohort 1: Dupilumab; medicine already approved by the FDA; Other Names: 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.	Other: Cohort 2: usual care only; Usual care that patients receive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Exacerbations	(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	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	(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	Major Adverse Cardiovascular Events (MACE), hospitalization, and all cause of death	End of study (2 years after the last participant is enrolled)
COPD Exacerbations	(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	(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	(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	(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	(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)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Exacerbation; Dupilumab; Dupixent; Home Spirometry
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; dupilumab
• Other Study ID Numbers: Pro00119059; SANOFI STUDY No: OBS21707 (Other Identifier: SANOFI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Time Frame: Study Duration
• IPD Sharing Access Criteria: Qualified researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes