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NCT Number: NCT07612878

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

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort 1: Dupilumab

Drug

medicine already approved by the FDA

Other names: Dupixent

Cohort 2: usual care only

Other

Usual care that patients receive

Primary outcomes

  1. Participant Characteristics

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

    Age

  2. Participant Characteristics

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

    Sex

  3. Patient Characteristics

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

    Height in meters

  4. Participant Characteristics

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

    Weight in kilograms

  5. Patients Characteristics

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

    BMI in kg/m^2

  6. Patients Characteristics

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

    Smoking and cannabis status/type/history

  7. Patient Characteristics

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

    Medical History

  8. Patient Characteristics

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

    Baseline disease characteristics

  9. Patient Characteristics

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

    Emphysema status

  10. Patient Characteristics

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

    Disease severity

  11. Patient Characteristics

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

    Eosinophil value

  12. Patient Characteristics

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

    COPD-relevant vaccination status

  13. Patient Characteristics

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

    Prior and current medications

  14. Patient Characteristics

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

    Previous and current comorbidities

  15. Patient Characteristics

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

    Reason(s) for initiation of dupilumab treatment

  16. Patient Characteristics

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

    Insurance Provider

Secondary outcomes

  1. COPD Exacerbations

    Time frame: 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

  2. FEV changes

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

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

  3. Changes in Quality of Life

    Time frame: 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.

  4. Events

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

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

  5. COPD Exacerbations

    Time frame: 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

  6. COPD Exacerbations

    Time frame: 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

  7. Changes in Quality of Life

    Time frame: 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

  8. Changes in Quality of Life

    Time frame: 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.

  9. Changes in Quality of Life

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency Trial Transparency

CONTACT

[email protected]

800-633-1610 option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Acronym: STRIDE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 29, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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