Cohort Study of Airway Microecology and the Pathogenesis and Evolution of Chronic Obstructive Pulmonary Disease

NCT04849104 | Active Not Recruiting

• 1 other identifier: COPD-BALF2021
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (4)

• Forced vital capacity(FVC)

  The change of FVC at each time node

  0， 12，24，36，48months

• Forced expiratory volume in the first second(FEV1)

  The change of FEV1 at each time node

  0， 12，24，36，48months

• Forced expiratory rate in the first second (FEV1%=FEV1/FVC)

  The change of FEV1% at each time node

  0， 12，24，36，48months

• Exhaled nitric oxide (FENO)

  The change of FENO at each time node

  0， 12，24，36，48months

Secondary Outcomes (2)

• breathlessness measurement using the modified British Medical Research Council (mMRC)

  0， 12， 24， 36， 48months

• COPD assessment test (CAT)

  0， 12， 24， 36， 48months

Study Arms (3)

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: 1. Forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) \<lower limit of normal value (LLN, 80%); 2. CT abnormalities: abnormal airway and/or emphysema, air retention or bronchial wall thickening; 3. 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%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatient or hospitalized patient

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (21)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

60ml bronchoalveolar lavage fluid

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Weining Xiong, doctor

  Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: February 26, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)