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COPD (Chronic Obstructive Pulmonary Disease)STRIDENCT07612878

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

An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Sanofi at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Cohort 1: Dupilumab
How many people
350 participants
Where
7 sitesUnited States
Study dates
6 Aug 2026to 30 Nov 2029
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: COPD patients who are newly referred to start dupilumab treatment

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Trial Transparency Trial Transparency contact

800-633-1610 option 6

Contact-us@sanofi.com

7 sites in 1 country

United States7 sites, 7 recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Michael Woods Study Coordinator, 614 293 4925, michael.woods@osumc.edu

    Phil Diaz, MD

    Recruiting

  • Duke

    Durham, North Carolina, 27705

    Jessica Shier, 919-620-7300, jessica.shier@duke.edu

    Matt McCravy, MD

    Recruiting

  • The Respire Institute

    Houston, Texas, 77094

    Janeth Rodriguez, 713 464 0899, jrodriguez@mpsds.com

    Murtuza Ahmed, MD

    Recruiting

  • IU Health Pulmonology & Critical Care Medicine

    Indianapolis, Indiana, 46202

    Kim McPeak, (317) 962-5820, kmcpeak@IUHealth.org

    Marc Rovner, MD, MMM, CPE, FACP, FCCP

    Recruiting

  • Activian Clinical Research

    Kingwood, Texas, 77339

    Katie Rice, 832 225 4800, krice@activian.com

    Amanbir Sohal, MD

    Recruiting

  • University of Kansas

    Lawrence, Kansas, 66045

    Laurin Brown, 913 588 2077, lbrown37@kumc.edu

    Matthew Sharpe, MD

    Recruiting

  • The Lung & Sleep Institute of North Texas

    North Richland Hills, Texas, 76180

    Neha Nair, 817-284-9225, neha@lungsleeptexas.com

    Tamer Hudali, MD MPH

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cohort 1: Dupilumab, Cohort 2: usual care only
Keywords
COPD, Dupilumab, Dupixent, Chronic Obstructive Pulmonary Disease, Exacerbation, Home Spirometry
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cohort 1: DupilumabDrug

    Also called Dupixent

    medicine already approved by the FDA

  • Cohort 2: usual care onlyOther

    Usual care that patients receive

Study groups in NCT07612878
Study groupRoleWhat they receive
Cohort 1: COPD participants prescribed dupilumab350 COPD consented participants prescribed dupilumab with prospective data collection
Receives: Drug: Cohort 1: Dupilumab
Cohort 2: Control COPD participants not prescribed dupilumab700 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.
Receives: Other: Cohort 2: usual care only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Characteristics

    Age

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

  2. Participant Characteristics

    Sex

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

  3. Patient Characteristics

    Height in meters

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

  4. Participant Characteristics

    Weight in kilograms

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

  5. Patients Characteristics

    BMI in kg/m^2

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

  6. Patients Characteristics

    Smoking and cannabis status/type/history

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

  7. Patient Characteristics

    Medical History

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

  8. Patient Characteristics

    Baseline disease characteristics

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

  9. Patient Characteristics

    Emphysema status

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

  10. Patient Characteristics

    Disease severity

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

  11. Patient Characteristics

    Eosinophil value

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

  12. Patient Characteristics

    COPD-relevant vaccination status

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

  13. Patient Characteristics

    Prior and current medications

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

  14. Patient Characteristics

    Previous and current comorbidities

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

  15. Patient Characteristics

    Reason(s) for initiation of dupilumab treatment

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

  16. Patient Characteristics

    Insurance Provider

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

Secondary outcomes (9)

  1. COPD Exacerbations

    (1a) Total number of moderate or severe COPD exacerbations in the 12 and 24 months after enrollment

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

  2. FEV changes

    Change from enrollment in FEV at 12 and 24 months after enrollment

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

  3. 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.

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

  4. Events

    Major Adverse Cardiovascular Events (MACE), hospitalization, and all cause of death

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

  5. COPD Exacerbations

    (1b) Total number of moderate COPD exacerbations in the 12 and 24 months after enrollment

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

  6. COPD Exacerbations

    (1c) Total number of severe COPD exacerbations in the 12 and 24 months after enrollment

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

  7. 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

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

  8. 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.

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

  9. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start6 Aug 2026
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612878
Sponsor's protocol ID
Pro00119059
Other IDs
SANOFI STUDY No: OBS21707
Acronym
STRIDE
Status last verified
Aug 2026
First submitted
19 May 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Sanofi at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency Trial Transparency (800-633-1610 option 6, Contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Characteristics (time frame: End of study (24 months after the last participant is enrolled)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07612878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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