An observational study in Chronic Obstructive Pulmonary Disease COPD, sponsored by Sanofi. Recruiting at 28 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Sanofi · Observational
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.
Study duration per participant is expected to be approximately 36 months.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 500 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
It is planned to recruit 350 to 500 participants, in up to 50 sites in France.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Dupilumab
Descriptive statistical analysis of socio-demographics
Time frame: Baseline
Descriptive statistical analysis of medical disease
Time frame: Baseline
Descriptive statistical analysis of treatment history
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (symptoms)
Time frame: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (exacerbations)
Time frame: In the 2 years prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (lung function parameters)
Time frame: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS])
Time frame: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)
Time frame: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels)
Time frame: 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)
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis))
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion)
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities)
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities)
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis)
Time frame: Baseline
Date of COPD diagnosis and GOLD grade/group at COPD diagnosis
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival)
Time frame: Baseline
Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation)
Time frame: Baseline
Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS).
Score range 0-42, higher values indicating a worse outcome
Time frame: Baseline
Descriptive statistical analysis of Vaccine status.
Time frame: Baseline
Descriptive statistical analysis of Emphysema assessment according to treating physician, based on CT scan
Time frame: In the last 3 years prior to treatment initiation
Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations
Time frame: After 12, 24 and 36 months compared to the year before baseline.
Change in exacerbation rate
Time frame: From treatment start to month 6, 12, 24 and 36.
Time to first exacerbation
Time frame: Since Dupilumab initiation and during the study period (3 years)
Cumulative moderate and severe exacerbations
Time frame: 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)
Time frame: From treatment start to month 6, 12, 24 and 36.
Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC)
Time frame: From treatment start to month 6, 12, 24 and 36
Change over time in pre- and post- bronchodilator forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC)
Time frame: From treatment start to month 6, 12, 24 and 36
Change over time in COPD Assessment Test (CAT) Score
Score range 0-40, higher values indicating a worse outcome
Time frame: From treatment start to month 6, 12, 24 and 36.
Change over time in modified Medical Research Council (mMRC) score
Score range 0-4, higher values indicating a worse outcome
Time frame: From treatment start to month 6, 12, 24 and 36.
Number of hospitalizations during dupilumab treatment vs. the year before dupilumab initiation
Time frame: After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before dupilumab initiation
Reason(s) for discontinuation of dupilumab treatment
Time frame: Month 6, 12, 24, and 36
Frequency and type of Adverse events (AEs)
Time frame: During the study period (3 years)
Frequency and type of possible dupilumab-related treatment-emergent adverse events (TEAEs)
Time frame: During the study period (3 years)
Change over time in the Residual Volume (RV)
Time frame: From treatment start to months 6, 12, 24 and 36.
Change over time in the Functional Residual Capacity (FRC)
Time frame: From treatment start to months 6, 12, 24 and 36.
Change over time in the Diffusion Lung Capacity for Carbon Monoxide [DLCO]
Time frame: From treatment start to months 6, 12, 24 and 36.
Number of missed workdays due to Chronic Obstructive Pulmonary Disease (COPD)
Time frame: After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before baseline
Number of major adverse cardiovascular events (MACE)
Time frame: After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before baseline
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Pulmonary Disease, Chronic Obstructive→
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