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Идёт набор NCT07136025

The Study About the Identification of Treatable Traits of Severe Asthma and the Construction of Personalized Treatment System

Без фазы С лечением Asthma

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: Individualized cluster management, Routine asthma treatment.
Кому может быть актуально
Состояния в реестре: Asthma. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Обзор

Severe asthma is a complex and heterogeneous disease. Patients with severe asthma can present with different types of airway inflammation, and are often accompanied by a variety of comorbidities and risk factors. Identification of potentially modifiable factors affecting prognosis, that is, "treatable characteristics", and individualized bundle management based on these characteristics may help to improve the quality of life of patients with asthma and improve the level of asthma control. Through joint research, this project aims to evaluate the treatable characteristics of asthma in patients with severe asthma in tertiary hospitals across the country, including lung function, fractional exhaled nitric oxide, blood routine, allergen IgE, chest CT, and a detailed questionnaire. The distribution of treatable characteristics of patients with severe asthma and its impact on the quality of life or asthma control level of patients were investigated. For patients with severe asthma, multidisciplinary consultation and shared decision-making were used to establish an individualized bundle management model based on the treatable characteristics of severe asthma. A 6-month randomized parallel controlled clinical trial was conducted to determine whether this model was superior to conventional management in improving the quality of life or asthma control in patients with severe asthma. The implementation of this project will build a new model of individualized management of severe asthma based on treatable characteristics and improve the management level of severe asthma

Вмешательства

  • Процедура Individualized cluster management
    Individualized cluster management for treatable traits
  • Процедура Routine asthma treatment
    Routine asthma treatment according to current guidelines

Первичные конечные точки

  • Changes from baseline in asthma quality of life score (AQLQ) at 6 months [Срок оценки: 6 months]
Вторичные конечные точки (3)
  • The change of asthma Control questionnaire (ACQ-5) score [Срок оценки: At 6 months]
  • Forced Expiratory Volume in 1 second（FEV1） [Срок оценки: At 6 months]
  • the number of asthma exacerbations within 6 months [Срок оценки: within 6 months]

Критерии участия

Критерии включения

  • Age ≥18 years, and <80 years with a definite diagnosis of asthma for at least 6 months
  • Patients met the 2024 GINA criteria for severe asthma, which was defined as "uncontrolled" asthma (frequent asthma symptoms, or frequent acute exacerbations) despite high-dose inhaled corticosteroids (ICS) plus long-acting β2-receptor antagonists (LABAs), or worsening of symptoms after slight tapering of high-dose therapy.
  • They were willing to accept multi-disciplinary and multi-dimensional evaluation and signed informed consent
  • Informed consent was obtained and patients were able to participate in the study and 6-month follow-up according to the protocol

Критерии исключения

  • The presence of numerous other lung tissue destructive diseases, such as severe bronchiectasis or pulmonary tuberculosis.
  • Chest surgery or abdominal surgery in the past 3 months
  • Eye surgery had been performed within the past 3 months
  • Myocardial infarction within the previous 3 months
  • Anti-tuberculosis treatment is ongoing
  • Women who are pregnant and lactating
  • Macrolide use within 4 weeks before the screening period
  • Treatment with anti-ige, anti-IL-5, or anti-IL-5R within 4 weeks before the screening period
  • Inhaled ICS+LABA+ long-acting anticholinergic agent (LAMA) for 4 weeks prior to the screening period 4. Allergy to macrolides
  • QTc interval prolongation >480ms
  • Taking medications that interact with azithromycin, causing QTc prolongation or existing ECG abnormalities, may lead to arrhythmia

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 10 центров
  • Beijing Institute of Respiratory Medicine and Beijing Chao-Yang Hospital, Capital Medical — Пекин
  • Beijing Tiantan Hospital Affiliated to Capital Medical University — Пекин
  • China-Japan Friendship Hospital — Пекин
  • The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
  • Henan Provincial People's Hospital — Чжэнчжоу
  • The Second Xiangya Hospital of Central South University — Чанша
  • The First Affiliated Hospital of China Medical University — Шэньян
  • The First Affiliated Hospital of Guangzhou Medical University — Шанхай
  • … и ещё 2 центра

Идентификаторы

NCT: NCT07136025 · 2025-KE-347

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗