ANEMODupilumab Effectiveness and Safety in COPD under Real-world Conditions
This observational study examines how Dupilumab, a medication, affects people with Chronic Obstructive Pulmonary Disease (COPD) in real-world settings, with a focus on changes in COPD Assessment Test (CAT) scores.
Data Collection
Collected from today forward - ProspectiveChronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This study aims to evaluate how well the medication Dupilumab works and how safe it is for people with Chronic Obstructive Pulmonary Disease (COPD) in real-world conditions. It focuses on understanding the long-term effects of Dupilumab on patients who are already using it, without altering their treatment plans. The study is important because it can provide valuable insights into how Dupilumab affects the everyday health and quality of life of people living with COPD, a condition that makes it hard to breathe and can significantly impact daily activities. Participants in the study continue their usual Dupilumab treatment as prescribed by their doctors, and researchers observe and record their health data during regular medical visits. The effectiveness of Dupilumab is measured through changes in the COPD Assessment Test (CAT) score, a questionnaire that helps evaluate the impact of COPD on a person's life. The study looks for improvements in CAT scores, where lower scores indicate better health. By gathering information on patient experiences and outcomes, the study aims to offer a clearer picture of how Dupilumab helps those with COPD in everyday life.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.350 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 18 locations
Investigational Site Number: DE18
Auerbach, GermanyOpen Investigational Site Number: DE18 in Google MapsInvestigational Site Number: DE21
Augsburg, GermanyInvestigational Site Number: DE13
Bad Homburg, GermanyInvestigational Site Number: DE19
Berlin, Germany