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Clinical Trial Summary

Bronchiectasis is a chronic inflammatory respiratory disease defined as the irreversible dilatation of one or more bronchi and is associated with chronic and frequently purulent expectoration, multiple exacerbations and progressive dyspnea. Bronchiectasis has a large heterogeneity. Different patients with bronchiectasis may have different etiology, clinical manifestations, and imaging features. Previous studies showed that there are significant relationship between the airway microbiome and the severity of the disease. For example, patient with airway Pseudomonas aeruginosa colonization has heavier symptoms, heavier severity, poorer quality of life, more acute exacerbations, and worse prognosis. A large number of studies have reported that long-term treatment of low-dose macrolides such as azithromycin or clarithromycin has anti-inflammatory and immunomodulatory effects, which can improve the clinical symptoms and disease progression of various chronic airway diseases, such as diffuse panbronchiolitis, chronic obstructive pulmonary disease, bronchiectasis. Both the 2017 European Respiratory Society guidelines and the 2019 British Thoracic Society Guideline recommend macrolide drugs for the treatment of chronic Pseudomonas aeruginosa colonization bronchiectasis or frequent acute exacerbations bronchiectasis, but the specific mechanism is unknown.This study is based on omics methods (Microbiology and Metabolomics) to deeply explore the composition of airway and gut microbiota in patients with bronchiectasis, the factors affecting the colonization of Pseudomonas aeruginosa and the mechanism of macrolides in the treatment of bronchiectasis. This study collected clinical data of bronchiectasis (including demographic information, clinical characteristics, lung function, and lung imaging), spontaneous sputum, stool, and peripheral blood, and followed up these patients for 12 months. Microbiology,metabolomics and cytokine in sputum and stool are tested, and cytokines, inflammatory mediators and metabolites in peripheral blood are tested. Through the above methods,investigators further understand the mechanism affecting progression of bronchiectasis and some factors that lead to the colonization of Pseudomonas aeruginosa, as well as mechanisms of macrolides in the treatment of bronchiectasis.


Clinical Trial Description

Clinical information: Demographic information,blood test results,lung function,severity of disease was evaluated using the E-FACED and the Bronchiectasis Severity Index (BSI).The severity of dyspnea was assessed using the Medical Research Council (MRC) grade, and lung radiological severity was assessed using the modified Reiff score and Bhalla score. Sputum collection: We collect sputum samples from patients with bronchiectasis. We divided into two parts from each sputum sample, one part was immediately stored -80℃ for microbiota sequencing, and the other part was diluted in PBS and centrifuge at 12,000g for 5 min, and supernatant stored at -80℃ for measurement of inflammatory mediators. Stool collection: We collect stool samples from patients with bronchiectasis.Fresh stools were processed in the laboratory within 30 min after collection and stored at -80°C until analysis. Peripheral blood collection: We collect peripheral blood samples from patients with bronchiectasis to detect inflammatory mediators and so on. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05731427
Study type Observational
Source Wuhan Union Hospital, China
Contact Xiaorong Wang
Phone 18627195231
Email rong-100@163.com
Status Recruiting
Phase
Start date February 1, 2021
Completion date February 1, 2026

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