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临床试验/NCT05731427
NCT05731427招募中不适用

Research on the Mechanism Affecting Progression of Bronchiectasis Based on Omics Method

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
4
主要终点
Acute exacerbations and mortality

研究概览

简要总结

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 project is a multicenter clinical study involving patients with bronchiectasis from Wuhan Union Hospital, Guizhou Provincial People's Hospital, and Yichang Central People's Hospital. Patients with bronchiectasis were recruited according to the inclusion and exclusion criteria. Clinical data were collected from these patients (including demographic information, clinical characteristics, pulmonary function, and lung imaging), along with spontaneously expectorated sputum, feces, and peripheral blood, and the patients were followed for 24 months. The microbiome, metabolome, and cytokines in sputum and feces were assessed, as well as cytokines, inflammatory mediators, and metabolites in peripheral blood.

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.

详细描述

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. The other part was diluted with PBS and centrifuged at 12000g for 5 minutes, and the supernatant was stored at -80°C for measurement of inflammatory factors, oxidative stress and other markers.

Stool collection:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Bronchiectasis confirmed by high-resolution computed tomographic scan(HRCT)
  • Chronic expectoration with ability to provide a sputum sample at the study visit
  • Provision of written informed consent

排除标准

  • Traction bronchiectasis
  • Lack of important clinical information

研究组 & 干预措施

Pseudomonas aeruginosa colonization group

Colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis

干预措施: Pseudomonas aeruginosa colonization infection (Diagnostic Test)

Non-Pseudomonas aeruginosa colonization group

No colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis

干预措施: Pseudomonas aeruginosa colonization infection (Diagnostic Test)

Before treatment with macrolides

Before treatment with macrolides in patients with bronchiectasis

干预措施: Macrolides (Drug)

After treatment with macrolides

After 6 months of treatment with macrolides for patients with bronchiectasis

干预措施: Macrolides (Drug)

结局指标

主要结局

Acute exacerbations and mortality

时间窗: February 10, 2026

The number of acute exacerbations and outcome (death or survival) of patients with bronchiectasis after one year.

次要结局

  • Lung function(February 10, 2026)
  • Symptoms assessment(February 10, 2026)
  • Stool and sputum microtioba(February 10, 2026)

研究者

发起方
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang xiaorong

Attending physician

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究点 (4)

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