Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06726356

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

Led by First Affiliated Hospital of Ningbo University · Updated on 2024-12-10

180

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Ningbo University

Lead Sponsor

S

Shenzhen Third People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the treatment of bronchiectasis, a condition with chronic cough, sputum production, and airway changes seen on lung imaging, often worsening with acute exacerbations. This study aims to evaluate whether bronchoscopic lavage using N-acetylcysteine combined with conventional treatment offers more benefit compared to conventional treatment alone or with saline lavage. The trial is a multicenter, blinded, randomized controlled study focusing on adults with bronchiectasis experiencing acute worsening of symptoms. The study involves 180 adult patients divided into three groups: one receiving standard treatment including anti-infective and expectorant therapies; a second group receiving saline bronchoalveolar lavage alongside standard care; and a third group receiving bronchoalveolar lavage with N-acetylcysteine plus saline in addition to conventional treatment. The lavage is administered with 90 ml per affected lung lobe, up to two lobes, totaling 180 ml. This setup allows comparison of the effects of different lavage solutions combined with usual care. Participants will be monitored for six months to assess the timing of acute exacerbations as the primary outcome. Secondary measures include changes in symptom scores such as mMRC, CAT, LCQ, and SGQR after one month, frequency of exacerbations, adverse effects, and need for repeat lavage. The study includes clinical evaluations, symptom questionnaires, and safety monitoring to understand the potential benefits and risks of adding N-acetylcysteine lavage to bronchiectasis treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and older but not older than 80 years
  • Chest CT scan showing bronchiectasis
  • Acute exacerbation of bronchiectasis with symptoms such as cough, sputum, chest tightness, or wheezing
  • Agreement to undergo bronchoscopy with bronchoalveolar lavage
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Severe heart or lung disease, coagulation disorders, poor tolerance to anesthesia, psychiatric disorders, or severe neuroses that prevent bronchoscopy
  • Low blood oxygen or inability to tolerate bronchoscopy or bronchoalveolar lavage during the procedure
  • Inability to cooperate with the study or considered unsuitable by the investigator
  • Significant airway bleeding that may worsen with bronchoalveolar lavage
  • Allergy to acetylcysteine
  • Missing required information

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 month

Participants receive conventional clinical treatment with or without bronchoalveolar lavage using saline or acetylcysteine solution, depending on group assignment.

1 baseline visit and multiple visits during treatment as needed

Follow-up

Duration - 6 months

Participants are followed for up to six months to monitor acute exacerbations and safety after treatment.

Periodic visits over 6 months

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China, 315010

Actively Recruiting

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Research Team

Z

Zhongbo Chen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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