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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

NCT ID: NCT07052396

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2029-07-01

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Dupilumab

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Site Number: DE18

Auerbach, , Germany

Site Status RECRUITING

Investigational Site Number: DE21

Augsburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE13

Bad Homburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE19

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: DE02

Berlin, , Germany

Site Status RECRUITING

Investigational Site Number: DE29

Burgwedel, , Germany

Site Status RECRUITING

Investigational Site Number: DE01

Darmstadt, , Germany

Site Status RECRUITING

Investigational Site Number: DE09

Erkelenz, , Germany

Site Status RECRUITING

Investigational Site Number: DE06

Flensburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE08

Fürstenwalde, , Germany

Site Status RECRUITING

Investigational Site Number: DE03

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE04

Hamburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE07

Hohenstein-Ernstthal, , Germany

Site Status RECRUITING

Investigational Site Number: DE10

Itzehoe, , Germany

Site Status RECRUITING

Investigational Site Number: DE24

Kaiserslauten, , Germany

Site Status RECRUITING

Investigational Site Number: DE25

Lüneburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE20

Marburg, , Germany

Site Status RECRUITING

Investigational Site Number: DE14

Markkleeberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Other Identifiers

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U1111-1314-5561

Identifier Type: REGISTRY

Identifier Source: secondary_id

OBS18596

Identifier Type: -

Identifier Source: org_study_id