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Идёт набор 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

— Наблюдательное Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dupilumab.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Германия · 18 центров
  • 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
  • … и ещё 10 центров

Идентификаторы

NCT: NCT07052396 · OBS18596 · U1111-1314-5561

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗