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Long-term follow-up of dupilumab treatment for COPD

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

Observational Sanofi · NCT07380711

This project will follow adults with uncontrolled COPD and high blood eosinophils who start dupilumab in routine care to see if it is safe and improves symptoms and quality of life over 36 months.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations22 sites (Aix-en-Provence and 21 other locations)
Trial IDNCT07380711 on ClinicalTrials.gov

What this trial studies

This is a non-interventional, partly retrospective and partly prospective observational follow-up of approximately 350–500 adults with COPD who start dupilumab as part of routine care. Participants will be followed for about 36 months across up to 50 sites in France, with data collected from medical records and patient-reported outcome questionnaires. The study will capture patient characteristics, safety events, treatment patterns, and measures such as exacerbations and quality-of-life scores without altering standard clinical care. Analyses will describe real-world outcomes and long-term safety in a population selected by elevated blood eosinophils and inadequate control on inhaled therapies.

Who should consider this trial

Good fit: Adults with COPD that remains uncontrolled despite LAMA/LABA/ICS (or LAMA/LABA if ICS unsuitable), with blood eosinophils ≥300 cells/µL, who are newly started on dupilumab according to the product label and consent to data use are ideal candidates.

Not a fit: People who are not eligible for dupilumab per the product label, who do not have elevated eosinophils, or who are participating in conflicting interventional trials are unlikely to benefit from joining this observational follow-up.

Why it matters

Potential benefit: If successful, the study could clarify long-term safety and real-world benefits of dupilumab for people with eosinophilic, uncontrolled COPD, helping doctors and patients make informed treatment choices.

How similar studies have performed: Early randomized and clinical data suggest IL-4/IL-13 blockade can help eosinophilic airway disease and some trials showed promising signals in eosinophilic COPD subgroups, but long-term real-world evidence is still limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Aix-en-Provence and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Disease COPD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.