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NCT Number: NCT05731427

Research on the Mechanism Affecting Progression of Bronchiectasis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guizhou Provincial people's Hospital, Guiyang, Guizhou, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pseudomonas aeruginosa colonization infection

Diagnostic Test

With or without airway Pseudomonas aeruginosa colonization infection

Macrolides

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lung function

    Time frame: February 10, 2026

    Forced expiratory volume in 1s (FEV1),Forced vital capacity(FVC)

  2. Symptoms assessment

    Time frame: February 10, 2026

    MRC score,cough score,sputum purulent score,sputum volume score and hemoptysis score

  3. Stool and sputum microtioba

    Time frame: February 10, 2026

    Stool and sputum microtioba from patients with bronchiectasis after one year

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaorong Wang

CONTACT

[email protected]

18627195231 ext. +86

Yaya Zhou

CONTACT

[email protected]

15972916036 ext. +86

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Feb 16, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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