Actively Recruiting
Long-term Observational Study of Dupilumab Treatment in Adults with COPD Assessing Patient Characteristics, Safety, and Reported Outcomes
Led by Sanofi · Updated on 2026-04-14
500
Participants Needed
22
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a long-term observational study to understand how dupilumab is used and its effects in patients with Chronic Obstructive Pulmonary Disease COPD who are treated as part of routine care. This study will follow about 350 to 500 participants in multiple sites across France over 36 months, collecting detailed information on patient characteristics, safety, and patient-reported outcomes. The goal is to describe various aspects of COPD and treatment history to better characterize this patient group. Participants in this study are those newly starting dupilumab treatment for COPD, as prescribed by their doctors in line with approved guidelines. The study does not involve any additional treatment but observes the use of dupilumab over time. No placebo or comparator group is included. Data will be collected retrospectively and prospectively, covering medical history before dupilumab initiation and ongoing treatment effects during the 36-month follow-up. Throughout the study, researchers will gather detailed data on demographics, disease characteristics, lung function, exacerbations, comorbidities, and patient-reported assessments such as quality of life and symptom scores. Safety outcomes, including adverse events and reasons for stopping treatment, will be monitored. The study duration for each participant is about 36 months, allowing long-term observation of treatment and disease progression in real-world conditions.
CONDITIONS
Brief Title
Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes
Research Team
T
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