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

Plain Language Summary

Simplified for easier understanding

This observational study tracks how well dupilumab (an injectable biologic drug) works in real-world clinical practice for people with COPD (chronic obstructive pulmonary disease) that remains uncontrolled despite standard inhaler treatments, and who have elevated blood eosinophils (a type of immune cell linked to inflammation). **You may be eligible if:** - You are an adult with COPD that remains poorly controlled despite being on combination inhaler therapy (LAMA/LABA/ICS or LAMA/LABA) - You have elevated blood eosinophil levels - Your doctor has decided to start you on dupilumab as part of your standard care - You are willing to allow your anonymized clinical data to be used in this study **You may NOT be eligible if:** - You do not meet the criteria for dupilumab according to the official prescribing information - You are currently in, or recently participated in, another study that might affect the results - You were hospitalized for a COPD flare-up within the past 4 weeks - You have a condition that limits your ability to complete questionnaires or participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.


Locations(18)

Investigational Site Number: DE18

Auerbach, Germany

Investigational Site Number: DE21

Augsburg, Germany

Investigational Site Number: DE13

Bad Homburg, Germany

Investigational Site Number: DE19

Berlin, Germany

Investigational Site Number: DE02

Berlin, Germany

Investigational Site Number: DE29

Burgwedel, Germany

Investigational Site Number: DE01

Darmstadt, Germany

Investigational Site Number: DE09

Erkelenz, Germany

Investigational Site Number: DE06

Flensburg, Germany

Investigational Site Number: DE08

Fürstenwalde, Germany

Investigational Site Number: DE03

Hamburg, Germany

Investigational Site Number: DE04

Hamburg, Germany

Investigational Site Number: DE07

Hohenstein-Ernstthal, Germany

Investigational Site Number: DE10

Itzehoe, Germany

Investigational Site Number: DE24

Kaiserslauten, Germany

Investigational Site Number: DE25

Lüneburg, Germany

Investigational Site Number: DE20

Marburg, Germany

Investigational Site Number: DE14

Markkleeberg, Germany

View Full Details on ClinicalTrials.gov

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NCT07052396


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