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Research on the Mechanism Affecting Progression of Bronchiectasis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05731427
Enrollment
150
Registered
2023-02-16
Start date
2021-02-01
Completion date
2030-12-31
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

Bronchiectasis, Microbiota, Pseudomonas aeruginosa

Brief 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 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.

Detailed 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. 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.

Interventions

DIAGNOSTIC_TESTPseudomonas aeruginosa colonization infection

With or without airway Pseudomonas aeruginosa colonization infection

Before or after 6 months of treatment with macrolides for patients with bronchiectasis

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Traction bronchiectasis * Lack of important clinical information

Design outcomes

Primary

MeasureTime frameDescription
Acute exacerbations and mortalityFebruary 10, 2026The number of acute exacerbations and outcome (death or survival) of patients with bronchiectasis after one year.

Secondary

MeasureTime frameDescription
Lung functionFebruary 10, 2026Forced expiratory volume in 1s (FEV1),Forced vital capacity(FVC)
Symptoms assessmentFebruary 10, 2026MRC score,cough score,sputum purulent score,sputum volume score and hemoptysis score
Stool and sputum microtiobaFebruary 10, 2026Stool and sputum microtioba from patients with bronchiectasis after one year

Countries

China

Contacts

Primary ContactXiaorong Wang
rong-100@163.com18627195231
Backup ContactYaya Zhou
749833758@qq.com15972916036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026