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Идёт набор NCT07362667

A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA

— Наблюдательное ABPA Allergic Bronchopulmonary Aspergillosis Allergic Bronchopulmonary Aspergillosis (ABPA) Airway Clearance

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: The patients were treated with bronchoscopic airway clearance and amphotericin B spraying.
Кому может быть актуально
Состояния в реестре: ABPA, Allergic Bronchopulmonary Aspergillosis, Allergic Bronchopulmonary Aspergillosis (ABPA), Airway Clearance. 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
Китай
Следующий шаг
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Официальное название

A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With Allergic Bronchopulmonary Aspergillosis

Обзор

To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis

Вмешательства

  • Процедура The patients were treated with bronchoscopic airway clearance and amphotericin B spraying
    In addition to standard medical therapy (oral glucocorticoids with or without oral antifungal agents), bronchoscopic airway clearance and bronchoscopic spraying of amphotericin B (depending on the effectiveness of bronchoscopic mucus plug removal, At least one time of bronchoscopic airway clearance and amphotericin B spraying). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc.

Первичные конечные точки

  • Radiographic response rate after 4 months of treatment [Срок оценки: 4 months]
  • Immunological remission rate after 4 months of treatment [Срок оценки: 4 months]
  • The remission rate of clinical symptoms after 4 months of treatment [Срок оценки: 4 months]
Вторичные конечные точки (11)
  • Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment [Срок оценки: 1 year]
  • Number of acute exacerbations within 2 years after 4 months of treatment [Срок оценки: 2 years]
  • Treatment response rate at 8 weeks [Срок оценки: 8 weeks]
  • Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis [Срок оценки: 2 years]
  • Time from discontinuation to first exacerbation [Срок оценки: 2 years]
  • After drug withdrawal, the number of patients who achieved treatment remission [Срок оценки: 2 years]
  • Quality of life score (AQLQ or mini-AQLQ) [Срок оценки: 2 years]
  • Serum total IgE [Срок оценки: 2 years]
  • All-cause mortality [Срок оценки: 2 years]
  • psychological Scale (Hospital Anxiety and Depression Scale, HADS) [Срок оценки: 2 years]
  • Aspergillus fumigatus sIgE [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Meet the diagnostic criteria of allergic bronchopulmonary aspergillosis, according to the ISHAM guidelines for the diagnosis and treatment of allergic bronchopulmonary aspergillosis (2024 revision), and the presence of mucus plugs or hyperattenuated mucus confirmed by chest high-resolution CT (HRCT).
  • Active disease: Newly diagnosed allergic bronchopulmonary aspergillosis or an acute exacerbation after discontinuation of treatment (defined as a > 14 day history of clinical worsening or radiographic progression of allergic bronchopulmonary aspergillosis and a ≥50% increase in total serum IgE from the last recorded value during the stable phase, excluding other causes of the acute exacerbation) in patients with previously diagnosed allergic bronchopulmonary aspergillosis.
  • Age ≥ 18 years old.

Критерии исключения

  • Allergic bronchopulmonary aspergillosis - serotype (i.e., meets the diagnostic criteria for allergic bronchopulmonary aspergillosis, but chest CT shows no obvious abnormality);
  • Patients with absolute or relative contraindications to electronic bronchoscopy;
  • Known history of allergy to amphotericin B or any of its excipients;
  • Patients with bronchiectasis caused by human immunodeficiency virus infection, active tuberculosis, pulmonary malignant tumor or other non-allergic bronchopulmonary aspergillosis;
  • Combined with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
  • Patients with previous or current smoking history;
  • Pregnant or lactating women;
  • Currently participating in other interventional clinical research;
  • Any other conditions considered by the investigator to preclude participation in the study (e.g., nonadherence, predicted survival <1 year, or severe mental illness that prevented cooperation).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical Univers — Цзинань

Идентификаторы

NCT: NCT07362667 · ABPA-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗