A Prospective, Multicenter, Observational Cohort Study on the Efficacy and Safety of Biological Agents 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
- 50
- 试验地点
- 1
- 主要终点
- Number of exacerbations (annual exacerbation rate)
研究概览
简要总结
To evaluate the efficacy and safety of biological agents in patients with 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).
- •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.
排除标准
- •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).
研究组 & 干预措施
Observation group: on the basis of the original standard drug treatment, combined with biological ag
干预措施: Biologic Agent (Drug)
The control group only received standard drug treatment (oral glucocorticoids with or without oral a
The standard medical regimen was oral prednisone (0.5mg/Kg/ day for 4 weeks, 0.25mg/Kg/ day for 4 weeks, followed by 0.125mg/Kg/ day for 4 weeks, followed by a reduction of 5mg every 2 weeks until discontinuation) with or without oral voriconazole (200mg bid, 1 hour before or after meals).
结局指标
主要结局
Number of exacerbations (annual exacerbation rate)
时间窗: 1 year and 2years
Acute exacerbations include acute exacerbation of allergic bronchopulmonary aspergillosis, acute exacerbation/attack of asthma, and acute exacerbation/bronchiectasis of infection. Acute exacerbation of allergic bronchopulmonary aspergillosis: in patients who have been diagnosed with allergic bronchopulmonary aspergillosis, persistent (\>14 days) clinical deterioration or worsening of imaging findings, accompanied by an increase in total serum IgE of \>50% from the last recorded value in the stable period, with no other cause of deterioration. Acute asthma exacerbation/exacerbation: worsening of respiratory symptoms for at least 48 hours without evidence of immunological or radiographic worsening of allergic bronchopulmonary aspergillosis; Acute exacerbation of infectious/bronchiectasis: clinical worsening for at least 48 hours, including cough, dyspnea, changes in sputum volume or texture, sputum purulence, fatigue, malaising, fever, or hemoptysis, without immunological or imaging worse
次要结局
- 8-week treatment response rate(8 weeks)
- Number of hospitalizations due to acute exacerbations of allergic bronchopulmonary aspergillosis(2 years)
- The time to the first exacerbation(2 years)
- The number of times achieved remission(2 years)
- Daily oral glucocorticoid use rate/average daily oral glucocorticoid dose/cumulative oral glucocorticoid dose(2 years)
- Proportion of patients who remain in remission after glucocorticoids are stopped(2 years)
- The use of antifungal drugs(2 years)
- asthma control test(ACT)(2 years)
- Serum total IgE(2 years)
- All-cause mortality(2 years)
- Aspergillus fumigatus sIgE(2 years)
- Aspergillus fumigatus sIgG(2 years)
- peripheral blood eosinophil count(2 years)
- Results of exhaled nitric oxide test(2 years)
研究者
Qian Qi
Prof.
Qianfoshan Hospital