COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, Dupilumab, Dupixent, Chronic Obstructive Pulmonary Disease, Exacerbation, Home Spirometry
Brief 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.
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.
Interventions
DRUGCohort 1: Dupilumab
medicine already approved by the FDA
OTHERCohort 2: usual care only
Usual care that patients receive
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Characteristics | End of study (24 months after the last participant is enrolled) | Age |
| Patient Characteristics | End of study (24 months after the last participant is enrolled) | Height in meters |
| Patients Characteristics | End of study (24 months after the last participant is enrolled) | BMI in kg/m\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COPD Exacerbations | 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 |
| FEV changes | End of study (2 years after the last participant is enrolled) | Change from enrollment in FEV at 12 and 24 months after enrollment |
| Changes in Quality of Life | 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. |
| Events | End of study (2 years after the last participant is enrolled) | Major Adverse Cardiovascular Events (MACE), hospitalization, and all cause of death |
Countries
United States
Contacts
CONTACTTrial Transparency Trial Transparency
Outcome results
None listed