The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry
Study of People With COPD Starting a Biologic Treatment
Study Overview
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.
Study Details
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: COPD (Chronic Obstructive Pulmonary Disease)
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Age: 40 years or above
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Gender: All
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
The purpose of this research study is to learn about the effects and safety of an approved biologic medicine in people with chronic obstructive pulmonary disease (COPD) who are newly starting this treatment in real-world care.
Participants will receive the biologic medicine as part of their usual medical care, with treatment decisions made by them and their regular health care professionals. The study will collect health information over time. Participants will also have chest images collected and stored for future research, and some participants who agree will measure their breathing at home using a device that checks lung function (home spirometry).
Who can participate:
Adults with COPD may be able to participate if they:
- Are 40 years or older
- Have COPD and are newly referred to start this biologic treatment
- Have had a standard breathing test (spirometry) at the baseline visit or within the past three months
Study timeline and visits:
Participation lasts about 2 years.
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