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RECRUITING
NCT07813299
NA

Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled Trial

Sponsor: First Affiliated Hospital of Ningbo University

View on ClinicalTrials.gov

Summary

Bronchiectasis is a chronic respiratory system disease characterized by irreversible structural dilation of the bronchi, persistent cough, and alternating periods of stability and acute exacerbation during the clinical course. Although airway clearance techniques (ACTs) are widely recommended, some hospitalized patients are unable to fully participate in conventional physical therapy due to respiratory difficulties or impaired sputum clearance. Bronchoscopic airway clearance therapy (B-ACT), combined with bronchoalveolar lavage under direct bronchoscopic visualization, can remove airway secretions. Previous studies have shown that bronchoscopy-guided airway clearance therapy (B-ACT) may prolong the time from discharge to the first exacerbation. In China, there have been studies exploring the use of bronchoscopy-guided alveolar lavage combined with local application of amikacin to treat patients with bronchiectasis. This study aims to explore whether the local application of amikacin after bronchoscopy-guided saline alveolar lavage provides greater benefits for patients with acute exacerbation of bronchiectasis compared to conventional treatment (non-bronchoscopy lavage) and bronchoscopy-guided saline alveolar lavage. The goal is to apply this treatment method in clinical practice to reduce the frequency of acute exacerbations in patients with bronchiectasis, improve prognosis, and enhance quality of life.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2026-05-15

Completion Date

2028-05-15

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

PROCEDURE

Bronchoalveolar Lavage and Local Amikacin Injection

While routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area.

PROCEDURE

Bronchoalveolar Lavage

While routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline.

Locations (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China