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

Efficacy and Safety of Bronchoalveolar Lavage with Acetylcysteine in the Treatment of Bronchiectasis with Infection in Adults: a Multicentre, Blinded, Randomised Controlled Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis with Acute Exacerbation
• Intervention / Treatment: Procedure: Bronchoalveolar Lavage

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).

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongbo Chen; Phone Number: 13777125910; Email: leonczb@163.com

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
      • Contact: Zhongbo Chen; Phone Number: 13777125910; Email: leonczb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; based on conventional clinical treatment including anti-infective and expectorant therapy.
Other: 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.	Procedure: 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.
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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first and second acute exacerbation	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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of mMRC scores	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.	one month
The change of CAT scores.	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.	one month
The change of LCQ scores.	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.	one month
The change of SGQR scores.	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.	one month
Number of acute exacerbations	Number of acute exacerbations in the three groups at 6 months after treatment.	six months
adverse effects	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.	one month
Re-treatment with bronchoalveolar lavage	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).	six months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Ningbo University
• Collaborators: Anhui Chest Hospital; Shenzhen Third People's Hospital; Jingzhou Central Hospital; Ninghai First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: bronchiectasis; acetylcysteine; bronchoalveolar lavage; Bronchoscopic airway clearance therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 2024-R036-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No