Status:
RECRUITING
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
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18+ years
Brief Summary
Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-w...
Detailed Description
Non-interventional Study. Patients receive Dupilumab in accordance with the summary of product characteristics in a real-world setting. The Dupilumab initiation must be independent of the study recrui...
Eligibility Criteria
Inclusion
- Participants willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.
- Adult participants.
- Participants with uncontrolled Chronic Obstructive Pulmonary Disease (COPD) despite long-acting muscarinic antagonist (LAMA)/ long-acting beta2-agonist (LABA)/ Inhaled Corticosteroid (ICS) (or LAMA/LABA if ICS are not appropriate) therapy and elevated blood eosinophils
- Participants newly initiated on dupilumab treatment as indicated in the dupilumab Summary of Product Characteristics (SmPC) in the specified label for COPD, determined by the treating physician, and independent of participation in the non-interventional study (NIS).
Exclusion
- Participants not eligible for dupilumab treatment according to SmPC.
- Participation in an ongoing interventional or observational study or participation in an interventional or observational study up to 12 months before enrolment that might, in the treating physician's opinion, influence the assessments for the current study.
- Any acute or chronic condition that, in the treating physician´s opinion, would limit the participants´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
- Participants hospitalized due to an exacerbation of their COPD within the last 4 weeks prior to enrolment.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07052396
Start Date
July 1 2025
End Date
July 1 2029
Last Update
December 22 2025
Active Locations (18)
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1
Investigational Site Number: DE18
Auerbach, Germany, 08209
2
Investigational Site Number: DE21
Augsburg, Germany, 86152
3
Investigational Site Number: DE13
Bad Homburg, Germany, 61350
4
Investigational Site Number: DE19
Berlin, Germany, 10717