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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Ningbo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bronchoalveolar Lavage and Local Amikacin Injection

    Procedure/Surgery

    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/Surgery

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

Treatment groups

186 Participants
are divided into 3 treatment groups
Group A: Group ANo intervention 0 interventions
Group B: Group BOther 1 intervention
Group C: Group CExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
six months

Secondary outcomes

1

The change of mMRC scores

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.

Time frame
one month]
2

The change of CAT scores

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.

Time frame
one month
3

The change of LCQ scores

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.

Time frame
one month
4

The change of SGQR scores

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.

Time frame
one month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Ningbo University

Lead sponsor

Anhui Chest Hospital

Collaborator

Ninghai First Hospital

Collaborator

Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University

Collaborator