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

NCT07813299 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Ningbo University

Phase

Not applicable

Started

2026-05-15

Last updated

2026-09-10

Condition(s) studied

Bronchiectasis With Acute Exacerbation

Investigational drug(s) / intervention(s)

Bronchoalveolar Lavage and Local Amikacin InjectionBronchoalveolar Lavage

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.

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Aged between 18 and 80 years, inclusive. 2. According to the adult bronchiectasis guidelines, diagnosed with bronchiectasis, and indicating lesions accumulating in 2 or more lung lobes. 3. Presenting with an acute exacerbation, defined by worsening of key symptoms (e.g., cough, sputum volume, dyspnea, chest tightness, or wheezing), and willing to undergo bronchoscopy with bronchoalveolar lavage (BAL). 4. Patients who are alert, cooperative, and able to tolerate the bronchoscopic procedure. 5. Provided written informed consent to participate in this clinical trial. Exclusion Criteria: 1. Presence of severe comorbidities or any contraindications to flexible bronchoscopy. 2. Intraoperative oxygen desaturation (SpO₂) or inability to tolerate bronchoalveolar lavage (BAL) following bronchoscopic insertion. 3. Declined participation or was deemed ineligible by the investigator for other reasons. 4. Coagulopathy (platelet count \< 50 × 10⁹/L) or active airway bleeding observed during bronchoscopy, posing a potential risk of exacerbation from BAL. 5. Incomplete procedural documentation or missing follow-up data. 6. Known allergy or hypersensitivity to amikacin. 7. Concurrent renal failure. 8. Diagnosis of cystic fibrosis.

Primary outcome measure(s)

Time of first acute exacerbation — six months
Length of post-treatment time points to first acute exacerbation (days) in all three groups of patients.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07813299 on ClinicalTrials.gov ↗ ← All trials in China