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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

NCT07052396

RecruitingN/A

Sponsor: Sanofi

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Dupilumab

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (18)

Auerbach, Germany
Augsburg, Germany
Bad Homburg, Germany
Berlin, Germany
Berlin, Germany
Burgwedel, Germany
Darmstadt, Germany
Erkelenz, Germany
Flensburg, Germany
Fürstenwalde, Germany
Hamburg, Germany
Hamburg, Germany
Hohenstein-Ernstthal, Germany
Itzehoe, Germany
Kaiserslauten, Germany
Lüneburg, Germany
Marburg, Germany
Markkleeberg, Germany