Research on the Mechanism Affecting Progression of Bronchiectasis

December 29, 2025 updated by: Wang xiaorong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
      • Yichang, Hubei, China, 443000
        • Recruiting
        • Department of Respiratory and Critical Care Medicine, Yichang Central People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients with bronchiectasis was recruited from Wuhan Union Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pseudomonas aeruginosa colonization group
Colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Diagnostic test: Pseudomonas aeruginosa colonization infection
With or without airway Pseudomonas aeruginosa colonization infection
Non-Pseudomonas aeruginosa colonization group
No colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Diagnostic test: Pseudomonas aeruginosa colonization infection
With or without airway Pseudomonas aeruginosa colonization infection
Before treatment with macrolides
Before treatment with macrolides in patients with bronchiectasis
Drug: Macrolides
Before or after 6 months of treatment with macrolides for patients with bronchiectasis
After treatment with macrolides
After 6 months of treatment with macrolides for patients with bronchiectasis
Drug: Macrolides
Before or after 6 months of treatment with macrolides for patients with bronchiectasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute exacerbations and mortality
Time Frame: February 10, 2026
The number of acute exacerbations and outcome (death or survival) of patients with bronchiectasis after one year.
February 10, 2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function
Time Frame: February 10, 2026
Forced expiratory volume in 1s (FEV1),Forced vital capacity（FVC）
February 10, 2026
Symptoms assessment
Time Frame: February 10, 2026
MRC score,cough score,sputum purulent score,sputum volume score and hemoptysis score
February 10, 2026
Stool and sputum microtioba
Time Frame: February 10, 2026
Stool and sputum microtioba from patients with bronchiectasis after one year
February 10, 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Xiaorong Wang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020XHHX002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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