Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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