NCT07380711 Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes
| NCT ID | NCT07380711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanofi |
| Condition | Chronic Obstructive Pulmonary Disease COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2030-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-01-28 with a primary completion date of 2030-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ contact-us@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT07380711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07380711 currently recruiting?
Yes, NCT07380711 is actively recruiting participants. Contact the research team at contact-us@sanofi.com for enrollment information.
Where is the NCT07380711 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Blois, France, Brest, France, Colmar, France and 11 additional locations.
Who is sponsoring the NCT07380711 clinical trial?
NCT07380711 is sponsored by Sanofi. The trial plans to enroll 500 participants.
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