Bronchiectasis With Acute Exacerbation
Conditions
Keywords
bronchiectasis, Amikacin, bronchoalveolar lavage, Bronchoscopic airway clearance therapy
Brief summary
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.
Detailed description
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).
Interventions
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.
PROCEDUREBronchoalveolar Lavage
While routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline.
Sponsors
First Affiliated Hospital of Ningbo University
Anhui Chest Hospital
Ninghai First Hospital
Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This study employs a blind evaluation method. Subjects were blinded, and researchers responsible for evaluating the improvement of patient symptom scores (CAT, LCQ, mMRC, SGRQ) and recording acute exacerbation information were also blinded. The bronchoscopy operators responsible for performing bronchoalveolar lavage and the personnel in charge of the patient's bed are not blinded. To avoid the evaluator's subjective bias, non-blind individuals should not disclose blind information to the evaluator.
Intervention model description
The patients were 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, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy), and Research Group C (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy; after lavage, a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) added to 20ml of saline was locally injected into the target bronchiectasis area).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
CONTACTZhongbo Chen
Outcome results
None listed