Cohort Study of Airway Microecology and the Pathogenesis and Evolution of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in the first second(FEV1)
研究概览
简要总结
This study will last for 5 years (2021.2.25-2025.12.31). 210 patients (70 cases in each group) will be enrolled in this study. Eight centers in China will participate in the study. The patients will be treated with bronchoscopy alveolar lavage, and 60 ml of bronchoalveolar lavage fluid will be collected for the next-generation sequencing of airway microorganisms. The patients will be followed up for 4 years to observe the changes of lung function, Fractional exhaled nitric oxide (FENO) and clinical symptoms.
详细描述
- Research purposes:
The main purpose: to detect the relationship between the changes in the airway microecology and the activation of macrophages, as well as the progression and heterogeneity of the early disease of COPD in patients with early COPD.
The basis of the question:
The current study found that the number of patients with COPD in my country is close to 100 million, and the number of deaths due to COPD every year ranks third among the deaths of each single disease in my country. However, the research on the pathogenesis of COPD has been slow and there is still no breakthrough. The results of research have brought innovations to the treatment of chronic obstructive pulmonary disease. The study found that the airway microecology has undergone significant changes in patients with moderate to severe COPD, but whether the airway microecology changes in the early COPD? If it changes, the airway microecology changes slowly in the early stage. What is the role in the evolution of obstructive lung disease? There is no relevant research report. This study intends to collect bronchoalveolar lavage fluid to detect the airway microecology and the activation of macrophages, and observe the changes in the airway microecology and the activation of macrophages in early COPD patients, as well as the early COPD Correlation between disease progression and heterogeneity. 2. Research design:
Planned number of cases: 70 cases of COPD high-risk patients/early COPD/mild-moderate COPD patients, a total of 210 cases. The main center plans to enroll 28 cases, each sub-center plans to enroll 26 cases, and each center enters the group competitively. 3. Clinical trial process:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the ability to communicate orally or in writing and sign an informed consent form;
- •Age from 18 to 70 years (the age of patients with mild to moderate COPD <75 years), regardless of gender;
- •Meet the above-mentioned early diagnosis criteria for high-risk patients with COPD/early-stage COPD/mild to moderate COPD.
排除标准
- •Patients suffering from any of the following diseases: active tuberculosis, severe bronchiectasis, lung abscess, aspiration pneumonia, lung tumor, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pneumothorax, pleural effusion , Pulmonary embolism, pulmonary eosinophilic infiltration, and pulmonary vasculitis;
- •Patients with a history of tumors or patients with current tumors;
- •The patient has severe renal impairment: creatinine clearance rate <30ml/min/1.73m2 or serum creatinine>265μmol/L (>3mg/dL);
- •Patients suffering from liver disease or severe liver damage: ALT, AST> 2 times the upper limit of normal;
- •Severe COPD, FEV1 predicted value ≤50%;
- •Severe heart disease, such as coronary heart disease, heart failure, etc.;
- •Severe coagulopathy: INR>1.4, PTT>40s, PLT<150x103 cells
- •Bronchial Asthma;
- •Severe alcoholism;
- •Have used antibiotics within two months,
- •Used systemic and local hormones;
- •Cannot sign the informed consent form;
研究组 & 干预措施
COPD high-risk patients
age <70 years old, long-term smoker (≥10 pack years), CT without macroscopic airway abnormalities and/or mild or moderate emphysema, air retention or bronchial thickening, normal lung function
Early-stage COPD patients
those who are younger than 70 years old, long-term smokers (≥10 pack years) and have any of the following abnormalities:
- Forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) <lower limit of normal value (LLN, 80%);
- CT abnormalities: abnormal airway and/or emphysema, air retention or bronchial wall thickening;
- FEV1 drops rapidly (≥60 mL/year);
patients with mild to moderate COPD
Patients with mild to moderate COPD: age <75 years, FEV1/FVC<70%, FEV1 predicted value ≥50%
结局指标
主要结局
Forced expiratory volume in the first second(FEV1)
时间窗: 0， 12，24，36，48months
The change of FEV1 at each time node
Forced vital capacity(FVC)
时间窗: 0， 12，24，36，48months
The change of FVC at each time node
Exhaled nitric oxide (FENO)
时间窗: 0， 12，24，36，48months
The change of FENO at each time node
Forced expiratory rate in the first second (FEV1%=FEV1/FVC)
时间窗: 0， 12，24，36，48months
The change of FEV1% at each time node
次要结局
- breathlessness measurement using the modified British Medical Research Council (mMRC)(0， 12， 24， 36， 48months)
- COPD assessment test (CAT)(0， 12， 24， 36， 48months)