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

NCT07052396 | Recruiting

• 2 other identifiers: OBS18596U1111-1314-5561
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 18

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline up to 12 months

Secondary Outcomes (26)

• Change from Baseline in CAT Score

  Baseline to up to 6 months and 24 months

• Analysis of Socio-demographics, Medical Disease and Treatment History

  Baseline

• Analysis of Clinical Disease Characteristics including Exacerbations

  Baseline

• Analysis of Clinical Disease Characteristics including Lung Function Parameters

  Baseline

• Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels

  Baseline

Interventions

Dupilumab DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (18)

Investigational Site Number: DE18

Auerbach, 08209, Germany

RECRUITING

Investigational Site Number: DE21

Augsburg, 86152, Germany

RECRUITING

Investigational Site Number: DE13

Bad Homburg, 61350, Germany

RECRUITING

Investigational Site Number: DE19

Berlin, 10717, Germany

RECRUITING

Investigational Site Number: DE02

Berlin, 14163, Germany

RECRUITING

Investigational Site Number: DE29

Burgwedel, 30938, Germany

RECRUITING

Investigational Site Number: DE01

Darmstadt, 64283, Germany

RECRUITING

Investigational Site Number: DE09

Erkelenz, 41812, Germany

RECRUITING

Investigational Site Number: DE06

Flensburg, 24937, Germany

RECRUITING

Investigational Site Number: DE08

Fürstenwalde, 15517, Germany

RECRUITING

Investigational Site Number: DE03

Hamburg, 20354, Germany

RECRUITING

Investigational Site Number: DE04

Hamburg, 22459, Germany

RECRUITING

Investigational Site Number: DE07

Hohenstein-Ernstthal, 09337, Germany

RECRUITING

Investigational Site Number: DE10

Itzehoe, 25524, Germany

RECRUITING

Investigational Site Number: DE24

Kaiserslauten, 67655, Germany

RECRUITING

Investigational Site Number: DE25

Lüneburg, 21339, Germany

RECRUITING

Investigational Site Number: DE20

Marburg, 35037, Germany

RECRUITING

Investigational Site Number: DE14

Markkleeberg, 04416, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (18)