Role of Small Bioactive Molecules in the Progression of Early COPD Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- lung function
研究概览
简要总结
To study the predictors contribute to the progression of COPD by follow-up of patients with early COPD and analyze their changes in bioactive molecular, exhaled gas, CT image, lung function, patient's symptoms and life quality.
详细描述
A research found that nearly 40% of patients with chronic respiratory symptoms who showed significant airway inflammation (airway wall thickening and/or lung structure destruction (emphysema) on chest CT had advanced COPD within 5 years, although their current lung function failed to meet diagnostic criteria for COPD. Current spirometry-based diagnostic methods are not the best predictors of COPD progression and death. CT indicated emphysema and airway inflammation were recognized as better predictors of disease progression and mortality. Based on a large cohort study, some scholars proposed the concept of "early COPD", focusing on people under the age of 50, smoking for more than 10 pack years, having one of the manifestations of early airflow limitation, abnormal chest CT, and rapid decline of FEV1, to study the mechanism of disease progression and early intervention methods.[4] In this study, we enroll participants with early COPD symptoms, to detect the progression of COPD with 3 years of follow-up. The predictors of disease progression and variants of bioactive molecular were analyzed, so as to clarify the progressive mechanism of COPD.
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
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •<60 years old;
- •Smoking ≥ 10 pack years.
- •With any of the following anomalies: a. Post-bronchodilator FEV1/FVC< 0.
- •b. CT image abnormalities: emphysema, air trapping or bronchial wall thickening; c.Rapid decrease of FEV1 (>60 ml/yr).
排除标准
- •With other known chronic lung diseases, including bronchiectasis, interstitial pulmonary disease, tuberculosis, and pulmonary vascular disease (CTEPH).
- •With severe pleural disease and/or lesions of the sternum or ribs.
- •Suffering from serious uncontrolled other systemic diseases, including chest and abdominal surgery, heart attack (angina pectoris, myocardial infarction, malignant arrhythmia, etc.) and cerebrovascular disease (stroke) within 3 months, as well as kidney disease (AKI), cirrhosis, and any malignant tumor except lung cancer.
- •Suffering from severe cognitive impairment.
- •With active tuberculosis or are taking anti-tuberculosis treatment.
- •Pregnancy or lactation.
- •Previous lung surgery.
- •Acute upper and lower respiratory system infection within 4 weeks.
结局指标
主要结局
lung function
时间窗: Lung function will be tested at the 1st year, the 2nd year and the 3rd year.
Patients' lung function will be tested to identify air flow decrease in the early COPD group and the control group.
次要结局
- Blood samples(The 1st year and the 3rd year of follow-up)
- CT(The 1st year and the 3rd year of follow-up)
- Exhaled breath condensate(The 1st year and the 3rd year)
- Exhaled hydrogen sulfide and nitric oxide(The 1st year and the 3rd year)
- Pulmonary tissue(The 1st year patients are enrolled)