Меню
Набор скоро начнётся NCT07612878

The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry

— Наблюдательное COPD (Chronic Obstructive Pulmonary Disease)

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: Cohort 1: Dupilumab, Cohort 2: usual care only.
Кому может быть актуально
Состояния в реестре: COPD (Chronic Obstructive Pulmonary Disease). 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and/or severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.

Подробное описание

This registry will enroll 350 participants with COPD newly initiated in dupilumab over a period of approximately 12 months at approximately 20 US sites experienced in the diagnosis and treatment of COPD. Data, chest images, and home spirometries will be collected from participants for approximately 2 years. Participant management and treatment decisions will be determined by participants and their health care professionals.

Вмешательства

  • Препарат Cohort 1: Dupilumab
    medicine already approved by the FDA
  • Другое Cohort 2: usual care only
    Usual care that patients receive

Первичные конечные точки

  • Participant Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Participant Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Participant Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patients Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patients Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Patient Characteristics [Срок оценки: End of study (24 months after the last participant is enrolled)]
Вторичные конечные точки (9)
  • COPD Exacerbations [Срок оценки: End of Study (24 months after the last participant is enrolled)]
  • FEV changes [Срок оценки: End of study (2 years after the last participant is enrolled)]
  • Changes in Quality of Life [Срок оценки: End of study (2 years after the last participant is enrolled)]
  • Events [Срок оценки: End of study (2 years after the last participant is enrolled)]
  • COPD Exacerbations [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • COPD Exacerbations [Срок оценки: End of study (24 months after the last participant is enrolled)]
  • Changes in Quality of Life [Срок оценки: End of study (2 years after the last participant is enrolled)]
  • Changes in Quality of Life [Срок оценки: End of study (2 years after the last participant is enrolled)]
  • Changes in Quality of Life [Срок оценки: End of study (2 years after the last participant is enrolled)]

Критерии участия

Критерии включения

  • COPD patients who are newly referred to start dupilumab treatment
  • Age ≥ 40 years
  • Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit

Критерии исключения

  • Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)
  • Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments
  • Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07612878 · Pro00119059 · SANOFI STUDY No: OBS21707

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗