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

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT07052396
• Lead Sponsor: Sanofi

Brief 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.

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study Start: 2025-06-30
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in COPD Assessment Test (CAT) Score	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 Outcome Measures

Name	Time	Method
Change from Baseline in CAT Score	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.
Analysis of Socio-demographics, Medical Disease and Treatment History	Baseline	Demographic data (age, sex \[f/m\], ethnicity, height, weight, BMI, vaccination status, smoking status, pack years) will be collected.
Analysis of Clinical Disease Characteristics including Exacerbations	Baseline	Number and severity grade of exacerbations in the year before study start will be assessed.
Analysis of Clinical Disease Characteristics including Lung Function Parameters	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.
Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels	Baseline	Analysis of clinical disease characteristics including EOS levels.
Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels	Baseline	Analysis of clinical disease characteristics including FeNO levels.
Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels	Baseline	Analysis of clinical disease characteristics including IgE levels.
Analysis of Clinical Disease Characteristics including Comorbidities	Baseline	Current and previous comorbidities (such as chronic rhinosinusitis, asthma, allergies, or cardiovascular comorbidities) will be assessed.
Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis	Baseline	Analysis of clinical disease characteristics including date of COPD diagnosis and GOLD grade/group at COPD diagnosis.
Annualized Rate of Moderate and Severe COPD Exacerbations	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.
Change in Rate of Moderate and Severe Exacerbations	Baseline to up to 6, 12 and 24 months	Change in rate of moderate and severe exacerbations will be assessed.
Change Over Time in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline to up to 6, 12 and 24 months	Change over time in pre- and post-bronchodilator FEV1 from study start.
Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group	Baseline	Analysis of clinical disease characteristics including current GOLD grade and group.
Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years	Baseline	Analysis of clinical disease characteristics including smoking status and pack years.
Time to First Moderate or Severe Exacerbation Since Study Start	Baseline to up to 6, 12 and 24 months	Time to first moderate or severe exacerbation since study start.
Cumulative Moderate and Severe Exacerbations Over Time	Baseline to up to 6, 12 and 24 months	Cumulative moderate and severe exacerbations over time
Change Over Time in Bronchodilator FEV1/Forced Vital Capacity (FVC)	Baseline to up to 6, 12 and 24 months	Change over time in pre- and post- bronchodilator FEV1/FVC from study start.
Change Over Time in Modified Medical Research Council (mMRC)	Baseline to up to 6, 12 and 24 months	Change over time in mMRC from study start.
Number of Missed Workdays due to COPD	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.
Number of Hospitalization After Dupilumab Treatment	Baseline to up to 6, 12 and 24 months	Number of hospitalizations after dupilumab treatment versus the year before study start.
Reason(s) for Initiation of Dupilumab Treatment	Baseline	Reason(s) for initiation of dupilumab treatment will be evaluated.
Occurrence of Product Technical Complaints (PTCs)	Baseline to up to 6, 12 and 24 months	Occurrence of PTCs will be evaluated.
Frequency of Adverse Events (AEs) During the Observation Period	Baseline to up to 24 months	Frequency of AEs will be evaluated during the observation period.
Type of AEs	Baseline to up to 24 months	Type of AEs will be evaluated during the observation period.
Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs)	Baseline to up to 24 months	Frequency of possible dupilumab-related TEAEs will be evaluated during the observational period.
Type of Possible Dupilumab-Related TEAEs	Baseline to up to 24 months	Type of possible dupilumab-related TEAEs will be evaluated during the observational period.