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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Germany
Investigational Site Number: DE18
RECRUITING
Auerbach
Investigational Site Number: DE13
RECRUITING
Bad Homburg
Investigational Site Number: DE02
RECRUITING
Berlin
Investigational Site Number: DE19
RECRUITING
Berlin
Investigational Site Number: DE01
RECRUITING
Darmstadt
Investigational Site Number: DE09
RECRUITING
Erkelenz
Investigational Site Number: DE06
RECRUITING
Flensburg
Investigational Site Number: DE03
RECRUITING
Hamburg
Investigational Site Number: DE04
RECRUITING
Hamburg
Investigational Site Number: DE07
RECRUITING
Hohenstein-ernstthal
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 350
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov