Research on the Mechanism Affecting Progression of Bronchiectasis

Recruiting

• Conditions: Bronchiectasis
• Interventions: Drug: Macrolides; Diagnostic Test: Pseudomonas aeruginosa colonization infection

• Registration Number: NCT05731427
• Lead Sponsor: Wuhan Union Hospital, China

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 study collected clinical data of bronchiectasis (including demographic information, clinical characteristics, lung function, and lung imaging), spontaneous sputum, stool, and peripheral blood, and followed up these patients for 12 months. Microbiology，metabolomics and cytokine in sputum and stool are tested, and cytokines, inflammatory mediators and metabolites in peripheral blood are tested.

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
After treatment with macrolides	Macrolides	After 6 months of treatment with macrolides for patients with bronchiectasis
Before treatment with macrolides	Macrolides	Before treatment with macrolides in patients with bronchiectasis
Pseudomonas aeruginosa colonization group	Pseudomonas aeruginosa colonization infection	Colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis
Non-Pseudomonas aeruginosa colonization group	Pseudomonas aeruginosa colonization infection	No colonization of Pseudomonas aeruginosa in the airways of patients with bronchiectasis

Primary Outcome Measures

Name	Time	Method
Acute exacerbations and mortality	February 10, 2026	The number of acute exacerbations and outcome (death or survival) of patients with bronchiectasis after one year.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China