A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA

Официальное название

A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents in Patients With Allergic Bronchopulmonary Aspergillosis

Обзор

To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.

Вмешательства

• Препарат Biologic Agent
  On the basis of the original standard drug treatment, biological agents were combined. All patients received at least 4 months of the same biologic agent, as recommended by the GINA2025 guidelines and assessed for response. It can be administered simultaneously with standard medical therapy or as maintenance therapy for 4 months on standard medical therapy. The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene

Первичные конечные точки

• Number of exacerbations (annual exacerbation rate) [Срок оценки: 1 year and 2years]

Вторичные конечные точки (12)

• 8-week treatment response rate [Срок оценки: 8 weeks]
• Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis [Срок оценки: 2 years]
• The time to the first exacerbation [Срок оценки: 2 years]
• The number of times achieved remission [Срок оценки: 2 years]
• Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose [Срок оценки: 2 years]
• Proportion of patients who remain in remission after glucocorticoids are stopped [Срок оценки: 2 years]
• The use of antifungal drugs [Срок оценки: 2 years]
• asthma control test(ACT) [Срок оценки: 2 years]
• Serum total IgE [Срок оценки: 2 years]
• All-cause mortality [Срок оценки: 2 years]
• Aspergillus fumigatus sIgE [Срок оценки: 2 years]
• Aspergillus fumigatus sIgG [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).
• The underlying disease was bronchial asthma, and it was severe bronchial asthma.
• Have had an acute asthma attack in the past year. Acute exacerbation of asthma is defined as the sudden onset of wheezing, shortness of breath, cough, chest tightness and other symptoms beyond the definition of uncontrolled asthma, or the aggravation of the original symptoms, and is characterized by decreased expiratory flow, often induced by exposure to allergens, irritants or respiratory tract infection.
• Blood eosinophil count ≥150 cells /μL.
• Age ≥ 18 years old.

Критерии исключения

• The underlying diseases were chronic obstructive pulmonary disease and bronchiectasis;
• Known allergic history to biological agents;
• Human immunodeficiency virus infection, active pulmonary tuberculosis or pulmonary malignant tumor;
• Complicated with other diseases requiring long-term systemic use of glucocorticoids or immunosuppressants (such as autoimmune diseases);
• 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: NCT07362693 · ABPA-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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