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

NCT07813299

RecruitingNA

Sponsor: First Affiliated Hospital of Ningbo University

Conditions: Bronchiectasis With Acute Exacerbation

Interventions: Bronchoalveolar Lavage and Local Amikacin Injection, Bronchoalveolar Lavage

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Ningbo, Zhejiang, China