Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07052396

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number: DE18, Auerbach, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Dupilumab

Drug

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from Baseline in CAT Score

    Time frame: Baseline to up to 6 months and 24 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.

  2. Analysis of Socio-demographics, Medical Disease and Treatment History

    Time frame: Baseline

    Demographic data (age, sex [f/m], ethnicity, height, weight, BMI, vaccination status, smoking status, pack years) will be collected.

  3. Analysis of Clinical Disease Characteristics including Exacerbations

    Time frame: Baseline

    Number and severity grade of exacerbations in the year before study start will be assessed.

  4. Analysis of Clinical Disease Characteristics including Lung Function Parameters

    Time frame: Baseline

    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.

  5. Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels

    Time frame: Baseline

    Analysis of clinical disease characteristics including EOS levels.

  6. Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels

    Time frame: Baseline

    Analysis of clinical disease characteristics including FeNO levels.

  7. Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels

    Time frame: Baseline

    Analysis of clinical disease characteristics including IgE levels.

  8. 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 current GOLD grade and group.

  9. Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years

    Time frame: Baseline

    Analysis of clinical disease characteristics including smoking status and pack years.

  10. Analysis of Clinical Disease Characteristics including Comorbidities

    Time frame: Baseline

    Current and previous comorbidities (such as chronic rhinosinusitis, asthma, allergies, or cardiovascular comorbidities) will be assessed.

  11. Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis

    Time frame: Baseline

    Analysis of clinical disease characteristics including date of COPD diagnosis and GOLD grade/group at COPD diagnosis.

  12. Annualized Rate of Moderate and Severe COPD Exacerbations

    Time frame: Baseline to up to 12 and 24 months

    Annualized rate of moderate and severe COPD exacerbations after 12 and 24 months versus the year before baseline.

  13. Change in Rate of Moderate and Severe Exacerbations

    Time frame: Baseline to up to 6, 12 and 24 months

    Change in rate of moderate and severe exacerbations will be assessed.

  14. Time to First Moderate or Severe Exacerbation Since Study Start

    Time frame: Baseline to up to 6, 12 and 24 months

    Time to first moderate or severe exacerbation since study start.

  15. Cumulative Moderate and Severe Exacerbations Over Time

    Time frame: Baseline to up to 6, 12 and 24 months

    Cumulative moderate and severe exacerbations over time

  16. 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 pre- and post-bronchodilator FEV1 from study start.

  17. 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 pre- and post- bronchodilator FEV1/FVC from study start.

  18. Change Over Time in Modified Medical Research Council (mMRC)

    Time frame: Baseline to up to 6, 12 and 24 months

    Change over time in mMRC from study start.

  19. Number of Missed Workdays due to COPD

    Time frame: Baseline to up to 6, 12 and 24 months

    Number of missed workdays due to COPD during the last year before baseline and after dupilumab treatment.

  20. Number of Hospitalization After Dupilumab Treatment

    Time frame: Baseline to up to 6, 12 and 24 months

    Number of hospitalizations after dupilumab treatment versus the year before study start.

  21. Reason(s) for Initiation of Dupilumab Treatment

    Time frame: Baseline

    Reason(s) for initiation of dupilumab treatment will be evaluated.

  22. Frequency of Adverse Events (AEs) During the Observation Period

    Time frame: Baseline to up to 24 months

    Frequency of AEs will be evaluated during the observation period.

  23. Type of AEs

    Time frame: Baseline to up to 24 months

    Type of AEs will be evaluated during the observation period.

  24. Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs)

    Time frame: Baseline to up to 24 months

    Frequency of possible dupilumab-related TEAEs will be evaluated during the observational period.

  25. Type of Possible Dupilumab-Related TEAEs

    Time frame: Baseline to up to 24 months

    Type of possible dupilumab-related TEAEs will be evaluated during the observational period.

  26. Occurrence of Product Technical Complaints (PTCs)

    Time frame: Baseline to up to 6, 12 and 24 months

    Occurrence of PTCs will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: ANEMO

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 4, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.