NCT04849104Active, not recruiting
Cohort Study of Airway Microecology and the Pathogenesis and Evolution of Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 210 (estimated)
- First submitted
- 8 Apr 2021
- Start date
- 26 Feb 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Diseases
- COPD
- NCT number
- NCT04849104
What you commit to
- Study type: Observational
- Planned participants: 210
- From 26 Feb 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- Severe heart disease, such as coronary heart disease, heart failure, etc.;
- diabetes;
Lab values
- 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 coagulopathy: INR\>1.4, PTT\>40s, PLT\<150x103 cells
Other
- pregnancy;
- Severe COPD, FEV1 predicted value ≤50%;
- Bronchial Asthma;
- Severe alcoholism;
- Have used antibiotics within two months,
- Used systemic and local hormones;
- Cannot sign the informed consent form;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.