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Набор скоро начнётся NCT07587658

This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization

Фаза IV С лечением 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, Placebo.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: от 40 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
Список центров уточняется — проверьте первичный протокол.
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 Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy of Dupilumab Added on to Standard of Care (SOC) Treatment vs SOC Treatment Following Hospitalization for a COPD Exacerbation

Обзор

This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days). The study is looking at another research question: • What side effects may happen from taking the study drug

Вмешательства

  • Препарат dupilumab
    Administered per the protocol
  • Препарат Placebo
    Administered per the protocol

Первичные конечные точки

  • Time to first all-cause event [Срок оценки: Through day 90]
  • Number of moderate or severe COPD exacerbations [Срок оценки: Through day 90]
Вторичные конечные точки (12)
  • Time to first COPD-related event [Срок оценки: Through day 90]
  • Time to first moderate and/or severe COPD exacerbation [Срок оценки: Through day 90]
  • Number of all-cause non-elective hospital readmissions [Срок оценки: Through day 90]
  • Number of ED visits [Срок оценки: Through day 90]
  • Number of COPD-related hospital readmissions [Срок оценки: Through day 90]
  • Number of COPD-related ED visits [Срок оценки: Through day 90]
  • Number of all-cause deaths [Срок оценки: Through day 90]
  • Number of COPD-related deaths [Срок оценки: Through day 90]
  • Occurrence of all-cause non-elective hospital readmissions [Срок оценки: Through day 60]
  • Occurrence of all-cause ED visits [Срок оценки: Through day 60]
  • Occurrence of all-cause deaths [Срок оценки: Through day 60]
  • Occurrence of COPD-related hospital readmissions [Срок оценки: Through day 60]

Критерии участия

Критерии включения

  • Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
  • Hospitalized or admitted to the ED >24 hours (from time of first admission or presentation to the ED) for acute exacerbation of COPD as primary diagnosis according to the principal investigator and exacerbation is managed by Systemic Corticosteroids (SCS) ± antibiotics and other appropriate treatments as per SOC
  • Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital

Критерии исключения

  • Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
  • Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
  • Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
  • Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
  • Cardiac-related comorbidity, as defined in the protocol
  • Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
  • Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07587658 · R668-COPD-2491 · 2025-524392-23-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗