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NCT Number: NCT07813299

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

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.

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Key information

Conditions

Bronchiectasis With Acute Exacerbation Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location status: Recruiting

Location contact

Zhongbo Chen

CONTACT

[email protected]

+8613777125910

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

  1. Time of first acute exacerbation

    Time frame: six months

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

Secondary outcomes

  1. The change of mMRC scores

    Time frame: 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.

  2. The change of CAT scores

    Time frame: 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.

  3. The change of LCQ scores

    Time frame: 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.

  4. The change of SGQR scores

    Time frame: 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.

  5. adverse effects

    Time frame: 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.

  6. Re-treatment with bronchoalveolar lavage

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongbo Chen

CONTACT

[email protected]

+8613777125910

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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