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RECRUITINGOBSERVATIONAL

Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes

Prospective and Retrospective Observational Real-world Study to Characterize Patients With COPD on Dupilumab Long-term Treatment, and Assess Safety and Patient Reported Outcomes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients willing and able to sign willing to sign a consent form for use of their pseudonymized clinical data within the present non-intervention study. - Adult patients. - Patients 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 (a blood eosinophil count ≥ 300 cells/microL). - Patients 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). Who Should NOT Join This Trial: - Patient not eligible for dupilumab treatment according to SmPC. - Participation in an ongoing interventional study or participation in an interventional 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 patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study. * Adult patients. * Patients 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 (a blood eosinophil count ≥ 300 cells/microL). * Patients 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: * Patient not eligible for dupilumab treatment according to SmPC. * Participation in an ongoing interventional study or participation in an interventional 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 patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (20)

Investigational Site Number : 2500021
Aix-en-Provence, France
Investigational Site Number : 2500043
Blois, France
Investigational Site Number : 2500044
Brest, France
Investigational Site Number : 2500009
Colmar, France
Investigational Site Number : 2500022
Juan-les-Pins, France
Investigational Site Number : 2500020
Le Chesnay, France
Investigational Site Number : 2500038
Libourne, France
Investigational Site Number : 2500033
Lyon, France
Investigational Site Number : 2500024
Marseille, France
Investigational Site Number : 2500002
Montpellier, France
Investigational Site Number : 2500047
Morlaix, France
Investigational Site Number : 2500040
Niort, France
Investigational Site Number : 2500026
Nîmes, France
Investigational Site Number : 2500017
Paris, France
Investigational Site Number : 2500001
Pessac, France
Investigational Site Number : 2500034
Pierre-Bénite, France
Investigational Site Number : 2500048
Saint-Pierre, France
Investigational Site Number : 2500029
Toulouse, France
Investigational Site Number : 2500010
Vantoux, France
Investigational Site Number : 2500035
Villeurbanne, France