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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated cohort | Dupilumab |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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It is planned to recruit 350 to 500 participants, in up to 50 sites in France.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | contact-us@sanofi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 2500021 | Recruiting | Aix-en-Provence | 13616 | France | ||
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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| 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 |
| 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. |
| Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC) | 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) | 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 | 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 | From treatment start to month 6, 12, 24 and 36. |
| Number of hospitalizations during dupilumab treatment vs. the year before dupilumab initiation | After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before dupilumab initiation |
| Reason(s) for discontinuation of dupilumab treatment | Month 6, 12, 24, and 36 |
| Frequency and type of Adverse events (AEs) | During the study period (3 years) |
| Frequency and type of possible dupilumab-related treatment-emergent adverse events (TEAEs) | During the study period (3 years) |
| Change over time in the Diffusion Lung Capacity for Carbon Monoxide [DLCO] | From treatment start to months 6, 12, 24 and 36. |
| Number of missed workdays due to Chronic Obstructive Pulmonary Disease (COPD) | After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before baseline |
| Number of major adverse cardiovascular events (MACE) | After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before baseline |
| Investigational Site Number : 2500043 |
| Recruiting |
| Blois |
| 41016 |
| France |
| Investigational Site Number : 2500044 | Recruiting | Brest | 29200 | France |
| Investigational Site Number : 2500009 | Recruiting | Colmar | 68024 | France |
| Investigational Site Number : 2500031 | Recruiting | Contamine-sur-Arve | 74130 | France |
| Investigational Site Number : 2500022 | Recruiting | Juan-les-Pins | 06600 | France |
| Investigational Site Number : 2500020 | Recruiting | Le Chesnay | 78157 | France |
| Investigational Site Number : 2500038 | Recruiting | Libourne | 33500 | France |
| Investigational Site Number : 2500033 | Recruiting | Lyon | 69008 | France |
| Investigational Site Number : 2500024 | Recruiting | Marseille | 13003 | France |
| Investigational Site Number : 2500002 | Recruiting | Montpellier | 34090 | France |
| Investigational Site Number : 2500047 | Recruiting | Morlaix | 29600 | France |
| Investigational Site Number : 2500040 | Recruiting | Niort | 79021 | France |
| Investigational Site Number : 2500026 | Recruiting | Nîmes | 30029 | France |
| Investigational Site Number : 2500017 | Recruiting | Paris | 400026 | France |
| Investigational Site Number : 2500001 | Recruiting | Pessac | 33604 | France |
| Investigational Site Number : 2500034 | Recruiting | Pierre-Bénite | 69495 | France |
| Investigational Site Number : 2500048 | Recruiting | Saint-Pierre | 97448 | France |
| Investigational Site Number : 2500028 | Recruiting | Toulouse | 31059 | France |
| Investigational Site Number : 2500029 | Recruiting | Toulouse | 31076 | France |
| Investigational Site Number : 2500010 | Recruiting | Vantoux | 57070 | France |
| Investigational Site Number : 2500035 | Recruiting | Villeurbanne | 69100 | France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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