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NCT Number: NCT06726356

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

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.

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Key information

Conditions

Bronchiectasis With Acute Exacerbation Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location status: Recruiting

Location contact

Zhongbo Chen

CONTACT

[email protected]

13777125910

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;
  • 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;
  • 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;

Treatment and study plan

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.

Primary outcomes

  1. Time of first and second acute exacerbation

    Time frame: 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.

Secondary outcomes

  1. The change of mMRC scores

    Time frame: 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.

  2. The change of CAT scores.

    Time frame: 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.

  3. The change of LCQ scores.

    Time frame: 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.

  4. The change of SGQR scores.

    Time frame: 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.

  5. Number of acute exacerbations

    Time frame: six months

    Number of acute exacerbations in the three groups at 6 months after treatment.

  6. adverse effects

    Time frame: 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.

  7. Re-treatment with bronchoalveolar lavage

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongbo Chen

CONTACT

[email protected]

13777125910

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Collaborators

  • Anhui Chest Hospital
  • Jingzhou Central Hospital
  • Ninghai First Hospital
  • Shenzhen Third People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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