Clinical trial NCT06726356: Value of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis.
Official title: Efficacy and Safety of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis with Infection in Adults: a Multicentre, Blinded, Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiectasis with Acute Exacerbation
Keywords: bronchiectasis; acetylcysteine; bronchoalveolar lavage; Bronchoscopic airway clearance therapy
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
Collaborators: name: Shenzhen Third People's Hospital
name: Anhui Chest Hospital
name: Ninghai First Hospital
name: Jingzhou Central Hospital
First posted: 2024-12-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group A (conventional clinical treatment), Control group B (application of saline bronchoalveolar lavage based on conventional clinical treatment), and group C (application of bronchoscopic acetylcysteine combined with saline alveolar lavage based on conventional clinical treatment), were randomly selected into the groups according to a predefined sequence of randomisation tables prior to the operation due to the nature of the intervention.
Primary purpose: TREATMENT

Brief 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.

Detailed description: All patients enrolled were patients with acute exacerbation of bronchiectasis. A total of 180 patients (1:1:1 allocation) with acute exacerbation of bronchiectasis were to be enrolled. The patients were divided into control group A (conventional clinical treatment including anti-infective and expectorant therapy), control group B (bronchoalveolar lavage with saline 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), and experimental group C (bronchoalveolar lavage with acetylcysteine solution in combination with saline 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).

Eligibility criteria: 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 outcomes:
measure: Time of first and second acute exacerbation
timeFrame: six months
Secondary outcomes:
measure: The change of mMRC scores
timeFrame: one month
measure: The change of CAT scores.
timeFrame: one month
measure: The change of LCQ scores.
timeFrame: one month
measure: The change of SGQR scores.
timeFrame: one month
measure: Number of acute exacerbations
timeFrame: six months
measure: adverse effects
timeFrame: one month
measure: Re-treatment with bronchoalveolar lavage
timeFrame: six months
Other outcomes:
Locations:
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: