Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes

NCT07380711 | Recruiting

• 1 other identifier: OBS19236
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 22

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.

Conditions

Chronic Obstructive Pulmonary Disease COPD

Outcome Measures

Primary Outcomes (21)

• Descriptive statistical analysis of socio-demographics

  Baseline

• Descriptive statistical analysis of medical disease

  Baseline

• Descriptive statistical analysis of treatment history

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (symptoms)

  In the 1 year prior to Dupilumab initiation

• Descriptive statistical analysis of clinical disease characteristics (exacerbations)

  In the 2 years prior to Dupilumab initiation

• Descriptive statistical analysis of clinical disease characteristics (lung function parameters)

  In the 1 year prior to Dupilumab initiation

• Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS])

  In the 1 year prior to Dupilumab initiation

• Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)

  In the 1 year prior to Dupilumab initiation

• Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels)

  In the 1 year prior to Dupilumab initiation

• Descriptive statistical analysis of clinical disease characteristics (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade and group)

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis))

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion)

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities)

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities)

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis)

  Baseline

• Date of COPD diagnosis and GOLD grade/group at COPD diagnosis

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival)

  Baseline

• Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation)

  Baseline

• Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS).

  Score range 0-42, higher values indicating a worse outcome

  Baseline

• Descriptive statistical analysis of Vaccine status.

  Baseline

• Descriptive statistical analysis of Emphysema assessment according to treating physician, based on CT scan

  In the last 3 years prior to treatment initiation

Secondary Outcomes (13)

• Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations

  After 12, 24 and 36 months compared to the year before baseline.

• Change in exacerbation rate

  From treatment start to month 6, 12, 24 and 36.

• Time to first exacerbation

  Since Dupilumab initiation and during the study period (3 years)

• Cumulative moderate and severe exacerbations

  Since Dupilumab initiation and during the study period (3 years)

• Change over time in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)

  From treatment start to month 6, 12, 24 and 36.

Other Outcomes (5)

• Change over time in the Residual Volume (RV)

  From treatment start to months 6, 12, 24 and 36.

• Change over time in the Functional Residual Capacity (FRC)

  From treatment start to months 6, 12, 24 and 36.

• Change over time in the Diffusion Lung Capacity for Carbon Monoxide [DLCO]

  From treatment start to months 6, 12, 24 and 36.

Study Arms (1)

Treated cohort

Dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is planned to recruit 350 to 500 participants, in up to 50 sites in France.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (22)

Investigational Site Number : 2500021

Aix-en-Provence, 13616, France

RECRUITING

Investigational Site Number : 2500043

Blois, 41016, France

RECRUITING

Investigational Site Number : 2500044

Brest, 29200, France

RECRUITING

Investigational Site Number : 2500009

Colmar, 68024, France

RECRUITING

Investigational Site Number : 2500031

Contamine-sur-Arve, 74130, France

RECRUITING

Investigational Site Number : 2500022

Juan-les-Pins, 06600, France

RECRUITING

Investigational Site Number : 2500020

Le Chesnay, 78157, France

RECRUITING

Investigational Site Number : 2500038

Libourne, 33500, France

RECRUITING

Investigational Site Number : 2500033

Lyon, 69008, France

RECRUITING

Investigational Site Number : 2500024

Marseille, 13003, France

RECRUITING

Investigational Site Number : 2500002

Montpellier, 34090, France

RECRUITING

Investigational Site Number : 2500047

Morlaix, 29600, France

RECRUITING

Investigational Site Number : 2500040

Niort, 79021, France

RECRUITING

Investigational Site Number : 2500026

Nîmes, 30029, France

RECRUITING

Investigational Site Number : 2500017

Paris, 400026, France

RECRUITING

Investigational Site Number : 2500001

Pessac, 33604, France

RECRUITING

Investigational Site Number : 2500034

Pierre-Bénite, 69495, France

RECRUITING

Investigational Site Number : 2500048

Saint-Pierre, 97448, France

RECRUITING

Investigational Site Number : 2500028

Toulouse, 31059, France

RECRUITING

Investigational Site Number : 2500029

Toulouse, 31076, France

RECRUITING

Investigational Site Number : 2500010

Vantoux, 57070, France

RECRUITING

Investigational Site Number : 2500035

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 2, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): August 14, 2030
• Study Completion (Estimated): August 14, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (22)