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

NCT06726356 | Recruiting DMC

• 1 other identifier: 2024-R036-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis with Acute Exacerbation

Keywords

bronchiectasis; acetylcysteine; bronchoalveolar lavage; Bronchoscopic airway clearance therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The change of mMRC scores

  one month

• The change of CAT scores.

  one month

• The change of LCQ scores.

  one month

• The change of SGQR scores.

  one month

• Number of acute exacerbations

  six months

Study Arms (3)

Group A

NO INTERVENTION

based on conventional clinical treatment including anti-infective and expectorant therapy.

Group B

OTHER

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

Group C

EXPERIMENTAL

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

Interventions

Bronchoalveolar Lavage PROCEDURE

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.

Group B; Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤80 years;
• Chest CT suggestive of bronchiectasis;
• 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
• patients who agreed to participate in the study and signed an informed consent form;

You may not qualify if:

• Severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, psychiatric disorders or severe neuroses that are contraindications to bronchoscopy;
• Intraoperative findings of decreased SPO2 or inability to tolerate bronchoscopy or inability to tolerate further bronchoalveolar lavage;
• Bronchoscopy of patients with significant intra-airway haemorrhage who may be at risk of exacerbation due to bronchoalveolar lavage;
• Patients with acetylcysteine allergy;
• Missing information;

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead
• Shenzhen Third People's Hospital: collaborator
• Anhui Chest Hospital: collaborator
• Ninghai First Hospital: collaborator
• Jingzhou Central Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Central Study Contacts

Zhongbo Chen

CONTACT

13777125910; leonczb@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects were blinded. Study personnel responsible for assessing patients' symptom scores and recording information on acute exacerbations were blinded whenever possible. The bronchoscopy operator responsible for giving bronchoalveolar lavage treatment and the person in charge of the patient's bed were not blinded. To avoid subjective bias on the part of the assessor, non-blind people should not disclose blinded information to the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 10, 2024
• Study Start: August 14, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)