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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2021年2月1日

概览

阶段
不适用
干预措施
Pseudomonas aeruginosa colonization infection
疾病 / 适应症
Bronchiectasis
发起方
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
入组人数
150
试验地点
4
主要终点
Acute exacerbations and mortality
状态
招募中
最后更新
3个月前

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: 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.

注册库
clinicaltrials.gov
开始日期
2021年2月1日
结束日期
2030年12月31日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

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

入排标准

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

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

Before treatment with macrolides

Before treatment with macrolides in patients with bronchiectasis

干预措施: Macrolides

After treatment with macrolides

After 6 months of treatment with macrolides for patients with bronchiectasis

干预措施: Macrolides

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)

研究点 (4)

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