The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry
Purpose
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.
Condition
- COPD (Chronic Obstructive Pulmonary Disease)
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Indianapolis, Indiana 46202
North Richland Hills, Texas 76180
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
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.