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

All enrolled patients are in the acute exacerbation phase of bronchiectasis. A total of 186 patients with acute exacerbation of bronchiectasis (1:1:1 allocation) who are willing to participate in this study and sign an informed consent form will be enrolled. The patients will be 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, using bronchoscopy to wash the affected lung lobe with 180ml of saline), and Research Group C (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline, followed by local injection of a mixture formed by adding 2 vials of Amikacin (specification: 0.2g/2ml) to 20ml of saline into the target bronchiectasis area).

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

Primary outcomes

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

Secondary outcomes

• The change of mMRC scores [one month]]: The modified Medical Research Council (mMRC) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). Categorised on a scale of 0 to 4, the higher the scale the more severe the symptoms are.
• The change of CAT scores [one month]: COPD assessment test (CAT) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). A score of 0-10 is considered mild, 11-20 is considered moderate, 21-30 is considered severe, and 31-40 is considered very severe.
• The change of LCQ scores [one month]: Leicester Cough Questionnaire (LCQ) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). Scores range from 3 to 21, with lower scores suggesting that cough has a greater impact on quality of life.
• The change of SGQR scores [one month]: St George's Respiratory Questionnaire (SGRQ) of all patients followed up at different time points (day 0, day 3, day 7, one month after treatment). The total score ranges from 0 to 100. Higher scores indicate poorer quality of life for the patient.
• adverse effects [one month]: Occurrence of post-treatment adverse effects (chest tightness, shortness of breath, worsening of respiratory failure, worsening of haemoptysis, complication of new pneumonia foci or signs of significant new infections considered to be related to lavage treatment) in the three groups of patients.
• Re-treatment with bronchoalveolar lavage [six months]: Hospitalisation for acute exacerbations requiring re-bronchoscopic lavage within 6 months in all three groups (re-bronchoscopic lavage may be considered for exacerbations after treatment: significant increase in sputum output, increase in the size of the lesion on CT).

Sex: All, ages: 18 Years to 80 Years

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.

• Results publication: 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
• Results publication: 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