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NCT Number: NCT07380711

Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, 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.

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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 : 2500021, Aix-en-Provence, France

Loading trial locations.

About this study

Study duration per participant is expected to be approximately 36 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Descriptive statistical analysis of socio-demographics

    Time frame: Baseline

  2. Descriptive statistical analysis of medical disease

    Time frame: Baseline

  3. Descriptive statistical analysis of treatment history

    Time frame: Baseline

  4. Descriptive statistical analysis of clinical disease characteristics (symptoms)

    Time frame: In the 1 year prior to Dupilumab initiation

  5. Descriptive statistical analysis of clinical disease characteristics (exacerbations)

    Time frame: In the 2 years prior to Dupilumab initiation

  6. Descriptive statistical analysis of clinical disease characteristics (lung function parameters)

    Time frame: In the 1 year prior to Dupilumab initiation

  7. Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS])

    Time frame: In the 1 year prior to Dupilumab initiation

  8. Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)

    Time frame: In the 1 year prior to Dupilumab initiation

  9. Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels)

    Time frame: In the 1 year prior to Dupilumab initiation

  10. Descriptive statistical analysis of clinical disease characteristics (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade and group)

    Time frame: Baseline

  11. Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis))

    Time frame: Baseline

  12. Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion)

    Time frame: Baseline

  13. Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities)

    Time frame: Baseline

  14. Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities)

    Time frame: Baseline

  15. Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis)

    Time frame: Baseline

  16. Date of COPD diagnosis and GOLD grade/group at COPD diagnosis

    Time frame: Baseline

  17. Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival)

    Time frame: Baseline

  18. Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation)

    Time frame: Baseline

  19. Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS).

    Time frame: Baseline

    Score range 0-42, higher values indicating a worse outcome

  20. Descriptive statistical analysis of Vaccine status.

    Time frame: Baseline

  21. 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

Secondary outcomes

  1. Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations

    Time frame: After 12, 24 and 36 months compared to the year before baseline.

  2. Change in exacerbation rate

    Time frame: From treatment start to month 6, 12, 24 and 36.

  3. Time to first exacerbation

    Time frame: Since Dupilumab initiation and during the study period (3 years)

  4. Cumulative moderate and severe exacerbations

    Time frame: Since Dupilumab initiation and during the study period (3 years)

  5. 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.

  6. Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC)

    Time frame: From treatment start to month 6, 12, 24 and 36

  7. 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

  8. Change over time in COPD Assessment Test (CAT) Score

    Time frame: From treatment start to month 6, 12, 24 and 36.

    Score range 0-40, higher values indicating a worse outcome

  9. Change over time in modified Medical Research Council (mMRC) score

    Time frame: From treatment start to month 6, 12, 24 and 36.

    Score range 0-4, higher values indicating a worse outcome

  10. 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

  11. Reason(s) for discontinuation of dupilumab treatment

    Time frame: Month 6, 12, 24, and 36

  12. Frequency and type of Adverse events (AEs)

    Time frame: During the study period (3 years)

  13. Frequency and type of possible dupilumab-related treatment-emergent adverse events (TEAEs)

    Time frame: During the study period (3 years)

Other outcomes

  1. Change over time in the Residual Volume (RV)

    Time frame: From treatment start to months 6, 12, 24 and 36.

  2. Change over time in the Functional Residual Capacity (FRC)

    Time frame: From treatment start to months 6, 12, 24 and 36.

  3. Change over time in the Diffusion Lung Capacity for Carbon Monoxide [DLCO]

    Time frame: From treatment start to months 6, 12, 24 and 36.

  4. 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

  5. Number of major adverse cardiovascular events (MACE)

    Time frame: After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before baseline

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

Registry information

Official study 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

Acronym: AURORA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 2, 2026
Registry last updated
Apr 14, 2026

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.

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