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Research on the Mechanism Affecting Progression of Bronchiectasis

U

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

Status

Enrolling

Conditions

Bronchiectasis

Treatments

Diagnostic Test: Pseudomonas aeruginosa colonization infection
Drug: Macrolides

Study type

Observational

Funder types

Other

Identifiers

NCT05731427
2020XHHX002

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 4 patient groups

Pseudomonas aeruginosa colonization group
Description:
Colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Treatment:
Diagnostic Test: Pseudomonas aeruginosa colonization infection
Non-Pseudomonas aeruginosa colonization group
Description:
No colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Treatment:
Diagnostic Test: Pseudomonas aeruginosa colonization infection
Before treatment with macrolides
Description:
Before treatment with macrolides in patients with bronchiectasis
Treatment:
Drug: Macrolides
After treatment with macrolides
Description:
After 6 months of treatment with macrolides for patients with bronchiectasis
Treatment:
Drug: Macrolides

Trial contacts and locations

3

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Central trial contact

Xiaorong Wang; Yaya Zhou

Data sourced from clinicaltrials.gov

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