Long-term follow-up of dupilumab treatment for COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Investigational Site Number : 2500021
  Aix-en-Provence, France Recruiting
• Investigational Site Number : 2500022
  Antibes, France Recruiting
• Investigational Site Number : 2500043
  Blois, France Recruiting
• Investigational Site Number : 2500044
  Brest, France Recruiting
• Investigational Site Number : 2500009
  Colmar, France Recruiting
• Investigational Site Number : 2500031
  Contamine-sur-Arve, France Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dupilumab added to standard COPD care after a flare-up

  This study tests whether adding dupilumab to usual COPD care after a severe flare requiring hospitalization can reduce the chance of another flare.

  Recruiting Phase 4 Regeneron Pharmaceuticals · Mullica Hill, New Jersey · NCT07587658

• Dupilumab for adults with COPD and high blood eosinophils in routine care

  This study will try dupilumab in adults with uncontrolled COPD and high blood eosinophils to see if it improves symptoms, quality of life, and safety over 24 months in routine care.

  Recruiting at 18 sites Sanofi · Auerbach and 17 other locations · NCT07052396

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• IOS-based platform to screen, diagnose, and manage COPD and asthma

  This study tests an Impulse Oscillometry system to screen for and diagnose COPD and asthma and to help predict flare-ups over about a year, involving adults in China.

  Recruiting Beijing Chao Yang Hospital · Beijing, Beijing Municipality · NCT07910409

• Targeted NMES to improve breathing and leg/extra muscle strength in COPD

  This study tests whether targeted neuromuscular electrical stimulation helps people with COPD see improvements in breathing muscle function and overall muscle strength.

  Recruiting Universitas Padjadjaran · Bandung, West Java · NCT07910006

• Dupilumab for Major Depressive Disorder

  This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07908563

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.