Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Immunoglobulin E (IgE)
研究概览
简要总结
To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. To screen the biomarkers that can be identified by CARAS Chinese medicine symptoms and different stages, and to provide a reference basis for individualised diagnosis and treatment of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with AR, BA and CARAS who meet the Western medical diagnostic criteria;
- •Chinese medical evidence consistent with lung qi deficiency evidence, phlegm-heat congestion of the lung evidence, or wind-heat offending the lung evidence;
- •Age 18 to 80 years;
- •Voluntarily accepted the study and signed an informed consent form;
- •Not participated in other clinical studies within 1 month before enrollment.
排除标准
- •Patients with combined vasomotor rhinitis and eosinophilic non-allergic rhinitis, other non-allergic rhinitis diseases that can cause symptoms such as nasal congestion and runny nose;
- •Patients who are participating in other drug trials;
- •Patients with a combination of other serious systemic diseases;
- •Pregnant or lactating women;
- •Patients with confusion, disorders of consciousness, dementia, and various psychiatric disorders.
结局指标
主要结局
Immunoglobulin E (IgE)
时间窗: Basline
Airway inflammation will be assessed using the IgE.
Interleukin-2、4、5、13 (IL-2、4、5、13)
时间窗: Basline
Airway inflammation will be assessed using the IL-2、4、5、13.
Interferon-γ (IFN-γ)
时间窗: Basline
Airway inflammation will be assessed using the IFN-γ.
Tumor necrosis factor-β (TNF-β)
时间窗: Basline
Airway inflammation will be assessed using the TNF-β.
Eosinophil cationic proteins (ECP)
时间窗: Basline
Airway inflammation will be assessed using the ECP.
次要结局
- Fractional exhaled nitric oxide (FeNO)(Basline)
- Forced vital capacity (FVC)(Basline)
- Forced expiratory volume in one second (FEV1)(Basline)
- Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)(Basline)
- FVC as the percentage of the predicted value (FVC%)(Basline)