Cytokine Profile of Allergic Bronchopulmonary Aspergillosis and Its Relevance to Severity and Exacerbation.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cytokines levels
研究概览
简要总结
The main aim of this study is to determine whether the levels of different inflammatory cytokines in the serum and BALF (bronchoalveolar lavage fluid) are relative to the severity and exacerbations of ABPA (allergic bronchopulmonary aspergillosis).
详细描述
The study would record patients' medical data at baseline and follow them up for different period of time. Updated data would be recorded and blood( or BALF) of the patients would be drawn for tests or stored as whole blood or serum at -80℃ when patients visit the hospital. Then the cytokine (A panel set by the manufacturer) of the serum and BALF would be tested . The secretion ability of peripheral blood mononuclear cells would also be verified. The investigators would then analyze the data and see if any cytokine is relative to the exacerbation or other indicators of the severity of ABPA.
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
- 是
入选标准
- •Patients diagnosed as allergic bronchopulmonary aspergillosis (ABPA). The diagnosis criteria of ABPA is as following: clinical diagnosis of asthma, elevated total IgE levels (> 1,000 IU/mL), presence of specific IgE against A fumigatus detected (> 0.35 kUA/L) or type 1 skin reaction to Aspergillus antigen. Other criteria(at least two of three): Presence of serum IgG antibodies (precipitins) against A. fumigatus; Radiographic pulmonary opacities consistent with ABPA(It might be transient consolidation, nodules, finger-in-glove opacities. Or it could be permanent bronchiectasis and pleuropulmonary fibrosis) Patients who sighed consent forms.
- •For asthma patients:
- •Diagnosis according to GINA.
- •For healthy control:
- •People with ongoing chronic allergic disease such as allergic rhinitis, asthma and allergic dermatitis are excluded.
排除标准
- •Patients who are unwilling to sign the consent form.
结局指标
主要结局
Cytokines levels
时间窗: 1 year
The levels of different cytokines in the serum or BALF at the enrollment and during follow up. The relation of different cytokines levels and characteristics of ABPA patients would be analyzed.
次要结局
- Exacerbation(1 year)
- Level of different cytokine secreting cells(1 year)
- FeNO(1 year)
- Phenotypes of ABPA(Once)
- Time to exacerbation(1 year)
- High attenuation mucus (HAM)(Once)
- Eosinophilia(1 year)
研究者
Jin-Fu Xu
Director of Respiratory Medicine
Shanghai Pulmonary Hospital, Shanghai, China