Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SANOFI STUDY No: OBS21707 | Other Identifier | SANOFI |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: COPD participants prescribed dupilumab | 350 COPD consented participants prescribed dupilumab with prospective data collection |
| |
| Cohort 2: Control COPD participants not prescribed dupilumab | 700 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1: Dupilumab | Drug | medicine already approved by the FDA |
|
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
COPD patients who are newly referred to start dupilumab treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Trial Transparency | Contact | 800-633-1610 option 6 | Contact-us@sanofi.com |
Not provided
Not provided
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
Study Duration
Qualified researchers
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cohort 2: usual care only | Other | Usual care that patients receive |
|
| 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) |
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) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |