NCT04259736

Prospective Cohort Study of Molecular Mechanism of Lower Respiratory Tract Microbes in Patients With AECOPD

A Prospective Cohort Study of Molecular Mechanism of Lower Respiratory Tract Microbes in Patients With Acute Obstructive Pulmonary Disease (AECOPD) by Regulating the Transcriptional Balance of NF-κB and PPARγ in Alveolar Macrophages

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

How to reduce the rapid decline of lung function in patients with AECOPD is a clinically urgent problem to be solved. Studies have suggested that there is a bacterial flora imbalance in the lower respiratory tract of COPD patients. To explore the relationship between microbiology and host immunity is a hot topic in the field of COPD. The investigators use NGS (next generation sequencing) technology to fully explore the specific molecular mechanism of the lower respiratory tract microbiome in patients with COPD by regulating the transcriptional activities of NF-κB and PPARγ in alveolar macrophages, resulting in pulmonary parenchymal remodeling and decreased lung function. In this study, a prospective cohort study will be used to evaluate the effect of the lower respiratory tract microbiome on lung tissue (alveolar space and pulmonary vascular) remodeling and pulmonary function decline in patients with AECOPD.

Detailed description

This study will be based on a prospective cohort design in patients with COPD who are eligible for the study. Fifty patients who met the criteria for inclusion and exclusion of COPD exacerbations and signed informed consent will participate in the study. The purpose of this study is to evaluate the effect of the lower respiratory tract microbiome on lung tissue remodeling, decreased lung function, and clinical symptoms in patients with AECOPD. Baseline screening includes demographic data, medical history, combined medication records, symptoms, signs, symptom scores, number of acute exacerbations, blood cells and inflammatory factors, electrocardiogram, lung function, alveolar lavage fluid microbe NGS, and safety observation indicators. Patients will be followed up every 3 months for a period of 1 year. The primary and secondary endpoints are as follows. Primary endpoint： Changes in FEV1 (forced expiratory volume in the first second) within 1 year of follow-up Secondary endpoint： Changes in CAT, CCQ, mMRC scores during 1 year of follow-up Changes in lung function during 1 year of follow-up: FEV1 / FVC Changes in blood routine, IgE, and eosinophil count within 1 year of follow-up Number of hospital admissions due to acute exacerbation during 1 year of follow-up

Conditions

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Microbiome

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-02-06
• Last updated: 2020-02-06

Locations

1 site across 1 country: China