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Recruiting Not applicable

Value of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis.

NCT06726356 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-08-14
Last updated
2024-12-10

Condition(s) studied

Bronchiectasis with Acute Exacerbation

Investigational drug(s) / intervention(s)

Bronchoalveolar Lavage

Bronchoalveolar Lavage: Bronchoalveolar lavage with saline or saline-acetylcysteine solution on the basis of conventional clinical treatment, with a volume of 90 ml per target lung lobe, up to a maximum of 2 lobes, and a total volume of up to 180 ml.

Study summary

Bronchiectasis is a clinical syndrome characterised by chronic cough, profuse sputum and/or intermittent haemoptysis, with or without shortness of breath and respiratory failure of varying severity, and abnormal thickening and dilatation of the bronchial walls as seen on lung imaging. Nebulised inhalation of N-acetylcysteine has been shown to significantly improve symptoms, shorten the length of hospital stay, reduce the rate of re-hospitalisation within six months, and improve lung function in patients with bronchiectasis with a high degree of safety. There have been no studies on the efficacy and safety of bronchoscopic irrigation with N-acetylcysteine solution in the treatment of bronchiectasis. The aim of this study was to investigate whether bronchoscopic acetylcysteine lavage combined with conventional treatment is more beneficial to patients with bronchiectasis than conventional treatment combined with conventional bronchoalveolar lavage and conventional treatment without bronchoscopy, respectively.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years and ≤80 years; 2. Chest CT suggestive of bronchiectasis; 3. meet the criteria for an acute exacerbation of bronchiectasis with symptoms such as cough, sputum, chest tightness or wheezing, and c. Patients who meet the criteria for an acute exacerbation of bronchiectasis with symptoms of cough, sputum, chest tightness or wheezing and who consent to bronchoscopy with bronchoalveolar lavage 4. patients who agreed to participate in the study and signed an informed consent form; Exclusion Criteria: 1. Severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, psychiatric disorders or severe neuroses that are contraindications to bronchoscopy; 2. Intraoperative findings of decreased SPO2 or inability to tolerate bronchoscopy or inability to tolerate further bronchoalveolar lavage; 3. Inability to co-operate with the study for any reason or in the opinion of the investigator, inappropriate for inclusion in the study for other reasons; 4. Bronchoscopy of patients with significant intra-airway haemorrhage who may be at risk of exacerbation due to bronchoalveolar lavage; 5. Patients with acetylcysteine allergy; 6. Missing information;

Primary outcome measure(s)

  • Time of first and second acute exacerbation — six months
    Description: Length of post-treatment time points to first acute exacerbation (days) and length of time points to second acute exacerbation (days) in all three groups of patients.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06726356 on ClinicalTrials.gov ↗ ← All trials in China