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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Radiographic response rate after 4 months of treatment
研究概览
简要总结
To evaluate the efficacy and safety of bronchoscopic airway clearance and amphotericin B spraying in the treatment of allergic bronchopulmonary aspergillosis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Observation group
The observation group was treated with standard drug therapy (oral glucocorticoids combined or not combined with oral antifungal drugs), combined with bronchoscopic airway clearance and amphotericin B spraying treatment
干预措施: The patients were treated with bronchoscopic airway clearance and amphotericin B spraying (Procedure)
Control group
Control group: The control group was treated with standard drug therapy (oral glucocorticoids with or without oral antifungal drugs). The previous treatment for bronchial asthma was maintained, including inhaled corticosteroids + long-acting β-receptor agonists, leukotriene receptor antagonists, etc.
结局指标
主要结局
Radiographic response rate after 4 months of treatment
时间窗: 4 months
Radiographic remission: defined as the removal of mucus plugs in the airway on radiographic examination
Immunological remission rate after 4 months of treatment
时间窗: 4 months
Immunological remission: defined as at least a 50% decrease in total serum IgE from baseline
The remission rate of clinical symptoms after 4 months of treatment
时间窗: 4 months
Clinical symptom relief: The semi-quantitative rating of clinical symptoms was evaluated using Likert scores with at least 50% improvement in symptoms
次要结局
- Number of acute exacerbations within 1 year of drug withdrawal after 4 months of treatment(1 year)
- Number of acute exacerbations within 2 years after 4 months of treatment(2 years)
- Treatment response rate at 8 weeks(8 weeks)
- Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis(2 years)
- Time from discontinuation to first exacerbation(2 years)
- After drug withdrawal, the number of patients who achieved treatment remission(2 years)
- Quality of life score (AQLQ or mini-AQLQ)(2 years)
- Serum total IgE(2 years)
- All-cause mortality(2 years)
- psychological Scale (Hospital Anxiety and Depression Scale, HADS)(2 years)
- Aspergillus fumigatus sIgE(2 years)
研究者
Qian Qi
Prof.
Qianfoshan Hospital