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

NCT07813299 | Recruiting DMC

• 1 other identifier: 2025-R066-03
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiectasis With Acute Exacerbation

Keywords

bronchiectasis; Amikacin; bronchoalveolar lavage; Bronchoscopic airway clearance therapy

Outcome Measures

Primary Outcomes (1)

• Time of first acute exacerbation

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

  six months

Secondary Outcomes (6)

• The change of mMRC scores

  one month]

• The change of CAT scores

  one month

• The change of LCQ scores

  one month

• The change of SGQR scores

  one month

• adverse effects

  one month

Study Arms (3)

Group A

NO INTERVENTION

Group B

OTHER

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

Procedure: Bronchoalveolar Lavage

Group C

EXPERIMENTAL

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 and Local Amikacin Injection

Interventions

Bronchoalveolar Lavage and Local Amikacin Injection PROCEDURE

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.

Group C

Bronchoalveolar Lavage PROCEDURE

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

Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 80 years, inclusive.
• According to the adult bronchiectasis guidelines, diagnosed with bronchiectasis, and indicating lesions accumulating in 2 or more lung lobes.
• 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).
• Patients who are alert, cooperative, and able to tolerate the bronchoscopic procedure.
• Provided written informed consent to participate in this clinical trial.

You may not qualify if:

• Presence of severe comorbidities or any contraindications to flexible bronchoscopy.
• Intraoperative oxygen desaturation (SpO₂) or inability to tolerate bronchoalveolar lavage (BAL) following bronchoscopic insertion.
• Declined participation or was deemed ineligible by the investigator for other reasons.
• Coagulopathy (platelet count \< 50 × 10⁹/L) or active airway bleeding observed during bronchoscopy, posing a potential risk of exacerbation from BAL.
• Incomplete procedural documentation or missing follow-up data.
• Known allergy or hypersensitivity to amikacin.
• Concurrent renal failure.
• Diagnosis of cystic fibrosis.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead
• Anhui Chest Hospital: collaborator
• Ninghai First Hospital: collaborator
• Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

Related Publications (2)

• Zhong NS, Qiu R, Cao J, Huang YM, Zhou H, Xu XX, Xu JF, Ye H, Yang ZR, Gao LY, Shen Y, Xiao ZK, Xie SG, Lin DJ, Zhao L, Xiong H, Zhang XM, Li FQ, Guan WJ, Chalmers JD; SAVE-BE trial investigators. Effects of the DPP-1 inhibitor HSK31858 in adults with bronchiectasis in China (SAVE-BE): a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2025 May;13(5):414-424. doi: 10.1016/S2213-2600(25)00019-0. Epub 2025 Mar 25.

  PMID: 40154523 RESULT

• Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.

  PMID: 26882271 RESULT

MeSH Terms

Conditions

Bronchiectasis

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Central Study Contacts

Zhongbo Chen

CONTACT

+8613777125910; leonczb@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study employs a blind evaluation method. Subjects were blinded, and researchers responsible for evaluating the improvement of patient symptom scores (CAT, LCQ, mMRC, SGRQ) and recording acute exacerbation information were also blinded. The bronchoscopy operators responsible for performing bronchoalveolar lavage and the personnel in charge of the patient's bed are not blinded. To avoid the evaluator's subjective bias, non-blind individuals should not disclose blind information to the evaluator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The patients were divided into three groups: Control Group A (based on routine clinical treatment, including anti-infection and expectorant therapy), Control Group B (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy), and Research Group C (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy; after lavage, a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) added to 20ml of saline was locally injected into the target bronchiectasis area).

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)