Chronic Obstructive Pulmonary Disease (COPD)ANEMONCT07052396
Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Sanofi at 18 sites in Germany.
Trial summary
Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-world setting over 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Dupilumab
- How many people
- 350 participants
- Where
- 18 sitesGermany
- Study dates
- 1 Jul 2025to 1 Jul 2029
- 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: Participants will be screened, enrolled, and documented by their treating physician. To avoid any selection bias, all eligible participants will be invited to participate in this study in the order in which their eligibility is determined (consecutive recruitment). Participants will be treated within clinical routine practice and according to the current standard of care. Participants who permanently discontinue dupilumab treatment and therefore terminate the study prior to the last visit at month 24 will be requested to complete an Early Termination visit.
Who may be able to join
- Participants willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.
- Adult participants.
- Participants 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
- Participants 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
- Participants not eligible for dupilumab treatment according to SmPC.
- Participation in an ongoing interventional or observational study or participation in an interventional or observational 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 participants´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
- Participants hospitalized due to an exacerbation of their COPD within the last 4 weeks prior to enrolment.
Trial locations and contacts
18 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
18 sites in 1 country
Germany18 sites, 18 recruiting
- Recruiting
Investigational Site Number: DE18
Auerbach, 08209
- Recruiting
Investigational Site Number: DE21
Augsburg, 86152
- Recruiting
Investigational Site Number: DE13
Bad Homburg, 61350
- Recruiting
Investigational Site Number: DE19
Berlin, 10717
- Recruiting
Investigational Site Number: DE02
Berlin, 14163
- Recruiting
Investigational Site Number: DE29
Burgwedel, 30938
- Recruiting
Investigational Site Number: DE01
Darmstadt, 64283
- Recruiting
Investigational Site Number: DE09
Erkelenz, 41812
- Recruiting
Investigational Site Number: DE06
Flensburg, 24937
- Recruiting
Investigational Site Number: DE08
Fürstenwalde, 15517
- Recruiting
Investigational Site Number: DE03
Hamburg, 20354
- Recruiting
Investigational Site Number: DE04
Hamburg, 22459
- Recruiting
Investigational Site Number: DE07
Hohenstein-Ernstthal, 09337
- Recruiting
Investigational Site Number: DE10
Itzehoe, 25524
- Recruiting
Investigational Site Number: DE24
Kaiserslauten, 67655
- Recruiting
Investigational Site Number: DE25
Lüneburg, 21339
- Recruiting
Investigational Site Number: DE20
Marburg, 35037
- Recruiting
Investigational Site Number: DE14
Markkleeberg, 04416
About this study
Official title: A Prospective, Non-interventional, Multicenter Observational Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With COPD Under Real-world Conditions
Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-world setting over 24 months.
Read the detailed description
Non-interventional Study. Patients receive Dupilumab in accordance with the summary of product characteristics in a real-world setting. The Dupilumab initiation must be independent of the study recruitment and patient data is documented based on clinical routine.
- Being tested
- Dupilumab
- 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.
DupilumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in COPD Assessment Test (CAT) Score
The COPD Assessment Test (CAT) is a questionnaire to assess the health status and quality of life of people with COPD. The questionnaire consists of eight simple statements, which participants answer using a numerical scale. The CAT score ranges from 0 to 40, with lower scores indicating a better health status.
Measured: Baseline up to 12 months
Secondary outcomes (26)
Change from Baseline in CAT Score
The COPD Assessment Test (CAT) is a questionnaire to assess the health status and quality of life of people with COPD. The questionnaire consists of eight simple statements, which participants answer using a numerical scale. The CAT score ranges from 0 to 40, with lower scores indicating a better health status.
Measured: Baseline to up to 6 months and 24 months
Analysis of Socio-demographics, Medical Disease and Treatment History
Demographic data (age, sex [f/m], ethnicity, height, weight, BMI, vaccination status, smoking status, pack years) will be collected.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Exacerbations
Number and severity grade of exacerbations in the year before study start will be assessed.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Lung Function Parameters
Lung function parameters such as forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, total lung capacity (TLC), residual volume (RV), sRtot, Diffusing capacity of the lungs for carbon monoxide (DLCO), DLCO/VA, Rtot, oxygen saturation in the blood will be assessed.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels
Analysis of clinical disease characteristics including EOS levels.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels
Analysis of clinical disease characteristics including FeNO levels.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels
Analysis of clinical disease characteristics including IgE levels.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group
Analysis of clinical disease characteristics including current GOLD grade and group.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years
Analysis of clinical disease characteristics including smoking status and pack years.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Comorbidities
Current and previous comorbidities (such as chronic rhinosinusitis, asthma, allergies, or cardiovascular comorbidities) will be assessed.
Measured: Baseline
Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis
Analysis of clinical disease characteristics including date of COPD diagnosis and GOLD grade/group at COPD diagnosis.
Measured: Baseline
Annualized Rate of Moderate and Severe COPD Exacerbations
Annualized rate of moderate and severe COPD exacerbations after 12 and 24 months versus the year before baseline.
Measured: Baseline to up to 12 and 24 months
Change in Rate of Moderate and Severe Exacerbations
Change in rate of moderate and severe exacerbations will be assessed.
Measured: Baseline to up to 6, 12 and 24 months
Time to First Moderate or Severe Exacerbation Since Study Start
Time to first moderate or severe exacerbation since study start.
Measured: Baseline to up to 6, 12 and 24 months
Cumulative Moderate and Severe Exacerbations Over Time
Cumulative moderate and severe exacerbations over time
Measured: Baseline to up to 6, 12 and 24 months
Change Over Time in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Change over time in pre- and post-bronchodilator FEV1 from study start.
Measured: Baseline to up to 6, 12 and 24 months
Change Over Time in Bronchodilator FEV1/Forced Vital Capacity (FVC)
Change over time in pre- and post- bronchodilator FEV1/FVC from study start.
Measured: Baseline to up to 6, 12 and 24 months
Change Over Time in Modified Medical Research Council (mMRC)
Change over time in mMRC from study start.
Measured: Baseline to up to 6, 12 and 24 months
Number of Missed Workdays due to COPD
Number of missed workdays due to COPD during the last year before baseline and after dupilumab treatment.
Measured: Baseline to up to 6, 12 and 24 months
Number of Hospitalization After Dupilumab Treatment
Number of hospitalizations after dupilumab treatment versus the year before study start.
Measured: Baseline to up to 6, 12 and 24 months
Reason(s) for Initiation of Dupilumab Treatment
Reason(s) for initiation of dupilumab treatment will be evaluated.
Measured: Baseline
Frequency of Adverse Events (AEs) During the Observation Period
Frequency of AEs will be evaluated during the observation period.
Measured: Baseline to up to 24 months
Type of AEs
Type of AEs will be evaluated during the observation period.
Measured: Baseline to up to 24 months
Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs)
Frequency of possible dupilumab-related TEAEs will be evaluated during the observational period.
Measured: Baseline to up to 24 months
Type of Possible Dupilumab-Related TEAEs
Type of possible dupilumab-related TEAEs will be evaluated during the observational period.
Measured: Baseline to up to 24 months
Occurrence of Product Technical Complaints (PTCs)
Occurrence of PTCs will be evaluated.
Measured: Baseline to up to 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (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 (COPD)Studies 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
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052396
- Sponsor's protocol ID
- OBS18596
- Other IDs
- U1111-1314-5561
- Acronym
- ANEMO
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Multicenter Observational Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With COPD Under Real-world Conditions
- ClinicalTrials.gov ID
- NCT07052396
- Acronym / sponsor ID
- ANEMO / OBS18596
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 4 Jul 2025 (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.
Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-world setting over 24 months.
Detailed description
Non-interventional Study. Patients receive Dupilumab in accordance with the summary of product characteristics in a real-world setting. The Dupilumab initiation must be independent of the study recruitment and patient data is documented based on clinical routine.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be screened, enrolled, and documented by their treating physician. To avoid any selection bias, all eligible participants will be invited to participate in this study in the order in which their eligibility is determined (consecutive recruitment). Participants will be treated within clinical routine practice and according to the current standard of care. Participants who permanently discontinue dupilumab treatment and therefore terminate the study prior to the last visit at month 24 will be requested to complete an Early Termination visit.
Key inclusion criteria (4 listed)
- Participants willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.
- Adult participants.
- Participants 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
- Participants 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)
- Participants not eligible for dupilumab treatment according to SmPC.
- Participation in an ongoing interventional or observational study or participation in an interventional or observational 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 participants´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
- Participants hospitalized due to an exacerbation of their COPD within the last 4 weeks prior to enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabThis study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. | Drug | – |
Primary outcome
Change from Baseline in COPD Assessment Test (CAT) Score
Time frame: Baseline up to 12 months
The COPD Assessment Test (CAT) is a questionnaire to assess the health status and quality of life of people with COPD. The questionnaire consists of eight simple statements, which participants answer using a numerical scale. The CAT score ranges from 0 to 40, with lower scores indicating a better health status.
26 secondary outcomes
Change from Baseline in CAT Score
Time frame: Baseline to up to 6 months and 24 months
Analysis of Socio-demographics, Medical Disease and Treatment History
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Exacerbations
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Lung Function Parameters
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Comorbidities
Time frame: Baseline
Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis
Time frame: Baseline
Annualized Rate of Moderate and Severe COPD Exacerbations
Time frame: Baseline to up to 12 and 24 months
Change in Rate of Moderate and Severe Exacerbations
Time frame: Baseline to up to 6, 12 and 24 months
Time to First Moderate or Severe Exacerbation Since Study Start
Time frame: Baseline to up to 6, 12 and 24 months
Cumulative Moderate and Severe Exacerbations Over Time
Time frame: Baseline to up to 6, 12 and 24 months
Change Over Time in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline to up to 6, 12 and 24 months
Change Over Time in Bronchodilator FEV1/Forced Vital Capacity (FVC)
Time frame: Baseline to up to 6, 12 and 24 months
Change Over Time in Modified Medical Research Council (mMRC)
Time frame: Baseline to up to 6, 12 and 24 months
Number of Missed Workdays due to COPD
Time frame: Baseline to up to 6, 12 and 24 months
Number of Hospitalization After Dupilumab Treatment
Time frame: Baseline to up to 6, 12 and 24 months
Reason(s) for Initiation of Dupilumab Treatment
Time frame: Baseline
Frequency of Adverse Events (AEs) During the Observation Period
Time frame: Baseline to up to 24 months
Type of AEs
Time frame: Baseline to up to 24 months
Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs)
Time frame: Baseline to up to 24 months
Type of Possible Dupilumab-Related TEAEs
Time frame: Baseline to up to 24 months
Occurrence of Product Technical Complaints (PTCs)
Time frame: Baseline to up to 6, 12 and 24 months
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 22 Dec 2025.
- 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
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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
18 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 18 sites in Germany.
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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. 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?
Change from Baseline in COPD Assessment Test (CAT) Score (time frame: Baseline up to 12 months). 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 22 Dec 2025.