RecruitingNCT07052396
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
A Prospective, Non-interventional, Multicenter Observational Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With COPD Under Real-world Conditions
Sponsor
Sanofi
Enrollment
350 participants
Start Date
Jul 1, 2025
Study Type
OBSERVATIONAL
Conditions
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-world setting over 24 months.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria4
- 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.
Interventions
DRUGDupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT07052396
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