Actively Recruiting
Long-term Observational Study of Dupilumab Effectiveness, Safety, and Patient Outcomes in Adults with Chronic Obstructive Pulmonary Disease COPD Under Real-world Conditions
Led by Sanofi · Updated on 2025-12-22
350
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how Dupilumab affects health-related quality of life, patient characteristics, efficacy, and safety in adults with Chronic Obstructive Pulmonary Disease COPD in a real-world setting over 24 months. This non-interventional study observes patients who have started Dupilumab treatment independently of the study, focusing on those with uncontrolled COPD despite standard inhaled therapies and elevated blood eosinophils. Patients receive Dupilumab as prescribed in routine clinical practice, with no treatment assigned by the study itself. The study collects data over two years, documenting changes in COPD symptoms, lung function, exacerbation rates, and safety outcomes as patients continue their usual care. During the study, participants clinical data, including COPD Assessment Test CAT scores, lung function tests, exacerbation frequency, and adverse events, are monitored at regular intervals up to 24 months. Patient-reported outcomes and other health measures are collected to understand Dupilumabs long-term effects in everyday use. The study also gathers information on hospitalizations, workdays missed, and reasons for treatment initiation.
CONDITIONS
Brief Title
Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign informed consent for use of pseudonymized clinical data
- Adult participants aged 18 years or older
- Diagnosed with uncontrolled COPD despite LAMA/LABA/ICS or LAMA/LABA therapy with elevated blood eosinophils
- Newly started on Dupilumab treatment as prescribed by treating physician independently of this study
You will not qualify if you...
- Not eligible for Dupilumab treatment according to product guidelines
- Participation in another interventional or observational study currently or within 12 months before enrollment that may affect assessments
- Any acute or chronic condition limiting ability to complete questionnaires or participate, as judged by physician
- Hospitalized due to COPD exacerbation within 4 weeks prior to enrollment
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
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