Chronic Obstructive Pulmonary Disease COPDAURORANCT07380711
Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes
An observational study of Chronic Obstructive Pulmonary Disease COPD, run by Sanofi at 28 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease COPD
- How many people
- 500 participants
- Where
- 28 sitesFrance
- Study dates
- 28 Jan 2026to 14 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to recruit 350 to 500 participants, in up to 50 sites in France.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
28 sites in 1 country
France28 sites, 28 recruiting
- Recruiting
Investigational Site Number : 2500021
Aix-en-Provence, 13616
- Recruiting
Investigational Site Number : 2500022
Antibes, 06606
- Recruiting
Investigational Site Number : 2500043
Blois, 41016
- Recruiting
Investigational Site Number : 2500044
Brest, 29200
- Recruiting
Investigational Site Number : 2500009
Colmar, 68024
- Recruiting
Investigational Site Number : 2500031
Contamine-sur-Arve, 74130
- Recruiting
Investigational Site Number : 2500046
Évreux, 27000
- Recruiting
Investigational Site Number : 2500003
La Tronche, 38700
- Recruiting
Investigational Site Number : 2500020
Le Chesnay, 78157
- Recruiting
Investigational Site Number : 2500038
Libourne, 33500
- Recruiting
Investigational Site Number : 2500006
Lille, 59037
- Recruiting
Investigational Site Number : 2500005
Lyon, 69004
- Recruiting
Investigational Site Number : 2500033
Lyon, 69008
- Recruiting
Investigational Site Number : 2500024
Marseille, 13003
- Recruiting
Investigational Site Number : 2500002
Montpellier, 34090
- Recruiting
Investigational Site Number : 2500047
Morlaix, 29600
- Recruiting
Investigational Site Number : 2500026
Nîmes, 30029
- Recruiting
Investigational Site Number : 2500040
Niort, 79021
- Recruiting
Investigational Site Number : 2500007
Paris, 75014
- Recruiting
Investigational Site Number : 2500017
Paris, 75018
- Recruiting
Investigational Site Number : 2500001
Pessac, 33604
- Recruiting
Investigational Site Number : 2500034
Pierre-Bénite, 69495
- Recruiting
Investigational Site Number : 2500004
Reims, 51092
- Recruiting
Investigational Site Number : 2500048
Saint-Denis, 97400
- Recruiting
Investigational Site Number : 2500028
Toulouse, 31059
- Recruiting
Investigational Site Number : 2500029
Toulouse, 31076
- Recruiting
Investigational Site Number : 2500010
Vantoux, 57070
- Recruiting
Investigational Site Number : 2500035
Villeurbanne, 69100
About this study
Official title: Prospective and Retrospective Observational Real-world Study to Characterize Patients With COPD on Dupilumab Long-term Treatment, and Assess Safety and Patient Reported Outcomes
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.
Read the detailed description
Study duration per participant is expected to be approximately 36 months.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treated cohort | Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistical analysis of socio-demographics
Measured: Baseline
Descriptive statistical analysis of medical disease
Measured: Baseline
Descriptive statistical analysis of treatment history
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (symptoms)
Measured: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (exacerbations)
Measured: In the 2 years prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (lung function parameters)
Measured: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS])
Measured: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)
Measured: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels)
Measured: 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)
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis))
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion)
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities)
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities)
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis)
Measured: Baseline
Date of COPD diagnosis and GOLD grade/group at COPD diagnosis
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival)
Measured: Baseline
Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation)
Measured: Baseline
Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS).
Score range 0-42, higher values indicating a worse outcome
Measured: Baseline
Descriptive statistical analysis of Vaccine status.
Measured: Baseline
Descriptive statistical analysis of Emphysema assessment according to treating physician, based on CT scan
Measured: In the last 3 years prior to treatment initiation
Secondary outcomes (13)
Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations
Measured: After 12, 24 and 36 months compared to the year before baseline.
Change in exacerbation rate
Measured: From treatment start to month 6, 12, 24 and 36.
Time to first exacerbation
Measured: Since Dupilumab initiation and during the study period (3 years)
Cumulative moderate and severe exacerbations
Measured: 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)
Measured: From treatment start to month 6, 12, 24 and 36.
Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC)
Measured: 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)
Measured: 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
Measured: 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
Measured: From treatment start to month 6, 12, 24 and 36.
Number of hospitalizations during dupilumab treatment vs. the year before dupilumab initiation
Measured: After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before dupilumab initiation
Reason(s) for discontinuation of dupilumab treatment
Measured: Month 6, 12, 24, and 36
Frequency and type of Adverse events (AEs)
Measured: During the study period (3 years)
Frequency and type of possible dupilumab-related treatment-emergent adverse events (TEAEs)
Measured: During the study period (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start28 Jan 2026
- Primary completion14 Aug 2030 (estimated)
- Study completion14 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease COPDStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380711
- Sponsor's protocol ID
- OBS19236
- Acronym
- AURORA
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Observational Real-world Study to Characterize Patients With COPD on Dupilumab Long-term Treatment, and Assess Safety and Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT07380711
- Acronym / sponsor ID
- AURORA / OBS19236
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 14 Aug 2030 (estimated)
- Study completion
- 14 Aug 2030 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study duration per participant is expected to be approximately 36 months.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated cohort | – | –Dupilumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to recruit 350 to 500 participants, in up to 50 sites in France.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: Baseline
Score range 0-42, higher values indicating a worse outcome
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
13 secondary outcomes
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
Time frame: From treatment start to month 6, 12, 24 and 36.
Change over time in modified Medical Research Council (mMRC) score
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease COPD, run by Sanofi at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive statistical analysis of socio-demographics (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.