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 a biologic medicine in people with chronic obstructive pulmonary disease (COPD) who are just starting this treatment in real-world care. Researchers will also describe the characteristics of people who start this treatment for COPD.
Participants will receive their COPD care and treatment decisions from their usual health care professionals. The study will collect health information over time. The study will also collect and store chest images for future research projects. Participants who agree will also do home spirometry (a breathing test done at home to measure lung function).
Who can participate:
People with COPD may be able to participate if they:
- Are 40 years old or older
- Have been newly referred to start this biologic treatment for COPD
- Have had standard COPD breathing tests (spirometry) done around the time of the first study visit (or within the past three months)
Study timeline and visits:
Participation lasts about 2 years.
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