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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

RecruitingNAAges 18 Years - 80 YearsAllFirst Affiliated Hospital of Ningbo University
NCT07813299 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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.
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What it tests

  • Bronchoalveolar Lavage and Local Amikacin Injection
  • Bronchoalveolar Lavage
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Where

1 site
The First Affiliated Hospital of Ningbo University
Ningbo, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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