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Recruiting NCT07052396

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

— Observational Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dupilumab.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change from Baseline in COPD Assessment Test (CAT) Score [Time frame: Baseline up to 12 months]
Secondary outcome measures (12)
  • Change from Baseline in CAT Score [Time frame: Baseline to up to 6 months and 24 months]
  • Analysis of Socio-demographics, Medical Disease and Treatment History [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Exacerbations [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Lung Function Parameters [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Comorbidities [Time frame: Baseline]
  • Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis [Time frame: Baseline]
  • Annualized Rate of Moderate and Severe COPD Exacerbations [Time frame: Baseline to up to 12 and 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 18 centers
  • Investigational Site Number: DE18 — Auerbach
  • Investigational Site Number: DE21 — Augsburg
  • Investigational Site Number: DE13 — Bad Homburg
  • Investigational Site Number: DE19 — Berlin
  • Investigational Site Number: DE02 — Berlin
  • Investigational Site Number: DE29 — Burgwedel
  • Investigational Site Number: DE01 — Darmstadt
  • Investigational Site Number: DE09 — Erkelenz
  • … and 10 more centers

Identifiers

NCT: NCT07052396 · OBS18596 · U1111-1314-5561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗