Study of airway microorganisms and their role in early chronic obstructive pulmonary disease

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

This study looks at how changes in airway germs might affect lung health in people with early chronic obstructive pulmonary disease (COPD) over five years.

Quick facts

• Study type: Observational
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04849104 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between airway microecology changes and the activation of macrophages in patients with early chronic obstructive pulmonary disease (COPD). Over a period of five years, 210 patients will be enrolled and treated with bronchoscopy alveolar lavage to collect samples for next-generation sequencing of airway microorganisms. The study will follow these patients for four years to monitor lung function, fractional exhaled nitric oxide levels, and clinical symptoms. The goal is to better understand the progression and heterogeneity of early COPD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with early-stage or mild to moderate COPD.

Not a fit: Patients with severe comorbidities or advanced COPD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to innovative treatments for early-stage COPD by identifying key microbial changes associated with disease progression.

How similar studies have performed: While studies have shown significant changes in airway microecology in moderate to severe COPD, this investigation into early-stage COPD is relatively novel.

Eligibility criteria

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;

Where this trial is running

Shanghai, Shanghai

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Junjie Yun, master

Conditions Chronic Obstructive Pulmonary Disease; chronic obstructive pulmonary disease