Status:
UNKNOWN
Cohort Study of Airway Microecology and the Pathogenesis and Evolution of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Brief Summary
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 b...
Detailed Description
1. 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- pregnancy;
- 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;
- diabetes;
- Have used antibiotics within two months,
- Used systemic and local hormones;
- Cannot sign the informed consent form;
Key Trial Info
Start Date :
February 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04849104
Start Date
February 26 2021
End Date
December 31 2025
Last Update
November 8 2022
Active Locations (1)
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1
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China, 200011