The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry
Recruiting · NCT07612878 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed across 3 US states.
- IU Health Pulmonology & Critical Care Medicine - Indianapolis, Indiana, United States
- Duke - Durham, North Carolina, United States
- The Lung & Sleep Institute of North Texas - North Richland Hills, Texas, United States