Dupilumab for adults with COPD and high blood eosinophils in routine care
A Prospective, Non-interventional, Multicenter Observational Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With COPD Under Real-world Conditions
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | dupilumab |
| Locations | 18 sites (Auerbach and 17 other locations) |
| Trial ID | NCT07052396 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with COPD who remain uncontrolled on LAMA/LABA/ICS (or LAMA/LABA if ICS are not appropriate), have elevated blood eosinophils, and have been newly started on dupilumab independent of the study are the ideal candidates.
Not a fit: Patients without elevated blood eosinophils, those already well controlled on standard inhaled therapies, or those in whom dupilumab is contraindicated are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, dupilumab could improve symptoms and quality of life for patients with eosinophilic, uncontrolled COPD in real-world practice.
How similar studies have performed: Dupilumab has demonstrated benefit in other type 2 inflammatory diseases such as asthma and atopic dermatitis, but real-world evidence and experience in COPD remain limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Auerbach and 17 other locations
- 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)
- Investigational Site Number: DE01 — Darmstadt, Germany (Recruiting)
- Investigational Site Number: DE09 — Erkelenz, Germany (Recruiting)
- Investigational Site Number: DE06 — Flensburg, Germany (Recruiting)
- Investigational Site Number: DE08 — Fürstenwalde, Germany (Recruiting)
- Investigational Site Number: DE03 — Hamburg, Germany (Recruiting)
- Investigational Site Number: DE04 — Hamburg, Germany (Recruiting)
- Investigational Site Number: DE07 — Hohenstein-Ernstthal, Germany (Recruiting)
- Investigational Site Number: DE10 — Itzehoe, Germany (Recruiting)
- Investigational Site Number: DE24 — Kaiserslauten, Germany (Recruiting)
- Investigational Site Number: DE25 — Lüneburg, Germany (Recruiting)
- Investigational Site Number: DE20 — Marburg, Germany (Recruiting)
- Investigational Site Number: DE14 — Markkleeberg, Germany (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.