CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 150 target
Drug / intervention
Macrolides +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05731427
NCT05731427N/ARecruitingOn TrackUpdated 5mo ago
Long Recruiting

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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology·observational·Posted Feb 16, 2023·Updated Jan 5, 2026

In Brief

An observational study evaluating Pseudomonas aeruginosa colonization infection and Macrolides for Bronchiectasis. Currently recruiting, targeting 150 participants across 3 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBronchiectasis
CountriesChina
Collaborators--

Timeline

N/ARecruiting
20212022202320242025202620272028202920302031
First PostedFeb 16, 2023
Enrollment StartFeb 1, 2021
Primary CompletionDec 31, 2030
TodayJul 1, 2026
Enrollment to primary: 9.9 yearsPosted 3.4 years agoPrimary completion in 4.5 years

Interventions

Pseudomonas aeruginosa colonization infectionother

With or without airway Pseudomonas aeruginosa colonization infection

Macrolidesdrug

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