Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase
Observational
Started
2021-02-26
Last updated
2026-04-14
Condition(s) studied
Chronic Obstructive Pulmonary Disease
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Have the ability to communicate orally or in writing and sign an informed consent form;
2. Age from 18 to 70 years (the age of patients with mild to moderate COPD \<75 years), regardless of gender;
3. Meet the above-mentioned early diagnosis criteria for high-risk patients with COPD/early-stage COPD/mild to moderate COPD.
Exclusion Criteria:
1. 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;
2. Patients with a history of tumors or patients with current tumors;
3. The patient has severe renal impairment: creatinine clearance rate \<30ml/min/1.73m2 or serum creatinine\>265μmol/L (\>3mg/dL);
4. Patients suffering from liver disease or severe liver damage: ALT, AST\> 2 times the upper limit of normal;
5. pregnancy;
6. Severe COPD, FEV1 predicted value ≤50%;
7. Severe heart disease, such as coronary heart disease, heart failure, etc.;
8. Severe coagulopathy: INR\>1.4, PTT\>40s, PLT\<150x103 cells
9. Bronchial Asthma;
10. Severe alcoholism;
11. diabetes;
12. Have used antibiotics within two months,
13. Used systemic and local hormones;
14. Cannot sign the informed consent form;
Primary outcome measure(s)
Forced vital capacity(FVC) — 0, 12,24,36,48months The change of FVC at each time node
Forced expiratory volume in the first second(FEV1) — 0, 12,24,36,48months The change of FEV1 at each time node
Forced expiratory rate in the first second (FEV1%=FEV1/FVC) — 0, 12,24,36,48months The change of FEV1% at each time node
Exhaled nitric oxide (FENO) — 0, 12,24,36,48months The change of FENO at each time node
Trial sites (1)
Facility
City
Region
Status
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University
Shanghai
Shanghai Municipality
More Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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