Cohort 1: Dupilumab: medicine already approved by the FDA
Cohort 2: usual care only: Usual care that patients receive
Study 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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Participant Characteristics — End of study (24 months after the last participant is enrolled) Age
Participant Characteristics — End of study (24 months after the last participant is enrolled) Sex
Patient Characteristics — End of study (24 months after the last participant is enrolled) Height in meters
Participant Characteristics — End of study (24 months after the last participant is enrolled) Weight in kilograms
Patients Characteristics — End of study (24 months after the last participant is enrolled) BMI in kg/m\^2
Patients Characteristics — End of study (24 months after the last participant is enrolled) Smoking and cannabis status/type/history
Patient Characteristics — End of study (24 months after the last participant is enrolled) Medical History
Patient Characteristics — End of study (24 months after the last participant is enrolled) Baseline disease characteristics
Patient Characteristics — End of study (24 months after the last participant is enrolled) Emphysema status
Patient Characteristics — End of study (24 months after the last participant is enrolled) Disease severity
Patient Characteristics — End of study (24 months after the last participant is enrolled) Eosinophil value
Patient Characteristics — End of study (24 months after the last participant is enrolled) COPD-relevant vaccination status
Patient Characteristics — End of study (24 months after the last participant is enrolled) Prior and current medications
Patient Characteristics — End of study (24 months after the last participant is enrolled) Previous and current comorbidities
Patient Characteristics — End of study (24 months after the last participant is enrolled) Reason(s) for initiation of dupilumab treatment
Patient Characteristics — End of study (24 months after the last participant is enrolled) Insurance Provider
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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