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.
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
350
medicine already approved by the FDA
Usual care that patients receive
Participant Characteristics
Age
Time frame: End of study (24 months after the last participant is enrolled)
Participant Characteristics
Sex
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Height in meters
Time frame: End of study (24 months after the last participant is enrolled)
Participant Characteristics
Weight in kilograms
Time frame: End of study (24 months after the last participant is enrolled)
Patients Characteristics
BMI in kg/m\^2
Time frame: End of study (24 months after the last participant is enrolled)
Patients Characteristics
Smoking and cannabis status/type/history
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Medical History
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Baseline disease characteristics
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Emphysema status
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Disease severity
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Eosinophil value
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
COPD-relevant vaccination status
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Prior and current medications
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Previous and current comorbidities
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Reason(s) for initiation of dupilumab treatment
Time frame: End of study (24 months after the last participant is enrolled)
Patient Characteristics
Insurance Provider
Time frame: End of study (24 months after the last participant is enrolled)
COPD Exacerbations
(1a) Total number of moderate or severe COPD exacerbations in the 12 and 24 months after enrollment
Time frame: 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
Time frame: 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.
Time frame: End of study (2 years after the last participant is enrolled)
Events
Major Adverse Cardiovascular Events (MACE), hospitalization, and all cause of death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: End of study (2 years after the last participant is enrolled)
Changes in Quality of Life
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(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.
Time frame: 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
Time frame: End of study (2 years after the last participant is enrolled)