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

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, observational study that follows adults with COPD who have been newly started on dupilumab by their treating physician. Patients receive dupilumab according to the approved product label and no treatment is assigned by the study. Clinical data, safety events, and patient-reported outcomes including health-related quality of life are collected from routine visits over 24 months. All data are pseudonymized and documented based on clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigational Site Number: DE18
  Auerbach, Germany Recruiting
• Investigational Site Number: DE21
  Augsburg, Germany Recruiting
• Investigational Site Number: DE13
  Bad Homburg, Germany Recruiting
• Investigational Site Number: DE19
  Berlin, Germany Recruiting
• Investigational Site Number: DE02
  Berlin, Germany Recruiting
• Investigational Site Number: DE29
  Burgwedel, Germany 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.

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• Long-term follow-up of dupilumab treatment for COPD

  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.

  Recruiting at 28 sites Sanofi · Aix-en-Provence and 27 other locations · NCT07380711

• Chronic Respiratory Disease Participant Engagement

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

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

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• Dupilumab for Major Depressive Disorder

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  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.