Bailing Capsules with Guben Kechuan Granules for stable bronchiectasis

Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules

This trial will try whether adding Bailing Capsules plus Guben Kechuan Granules to standard Western treatment reduces acute exacerbations in adults with stable bronchiectasis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 5 sites (Hangzhou, Zhejiang and 4 other locations)
• Trial ID: NCT07114120 on ClinicalTrials.gov

What this trial studies

Adults with stable bronchiectasis who meet entry criteria are assigned to receive either Bailing Capsules plus Guben Kechuan Granules alongside standard Western medical treatment or standard Western medical treatment alone for 24 weeks. The herbal regimen is given orally (four Bailing Capsules three times daily and one bag of Guben Kechuan Granules three times daily) with clinic visits and testing at baseline and prespecified follow-ups (for example at weeks 4, 12 and 24). Key outcomes include the number of acute exacerbations over the treatment period, lung function measures (FEV1/FVC), and monitoring for adverse events to characterize safety. Eligibility requires age 18–80, documented bronchiectasis with at least two exacerbations in the past year, no recent (past 4 weeks) respiratory infection or exacerbation, and ability to perform pulmonary function tests.

Who should consider this trial

Good fit: Adults aged 18–80 with clinically diagnosed stable bronchiectasis, documented airflow limitation (FEV1/FVC <70%), at least two exacerbations in the prior year, and no respiratory infection or exacerbation within the past four weeks are ideal candidates.

Not a fit: Patients with a recent (within 4 weeks) exacerbation or active respiratory infection, those without recurrent exacerbations, or people with severe comorbidities or inability to attend scheduled visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could reduce the frequency of acute bronchiectasis exacerbations and help patients remain clinically more stable with an acceptable safety profile.

How similar studies have performed: Prior studies of these traditional Chinese medicine formulations are limited and generally small or mixed in quality, so consistent high-quality evidence for reducing bronchiectasis exacerbations is lacking.

Eligibility criteria

Inclusion Criteria:

1. 18-80 years old, gender not limited;
2. It conforms to the Western medical diagnosis of bronchiectasis;
3. There has been no acute exacerbation or respiratory tract infection in the past 4 weeks. (Acute exacerbation is defined as the deterioration of three or more of the following six conditions: cough, changes in sputum volume, purulent sputum, breathing difficulties or exercise tolerance, fatigue or discomfort, and hemoptysis, lasting for more than 48 hours, and considered by the clinician to require treatment);
4. There have been at least two documented acute exacerbations in the past year, prescribed by doctors and diagnosed as signs and symptoms of respiratory tract infections;
5. Pulmonary function tests can be conducted, and there is evidence of airflow limitation when screening vital capacity (FEV1/FVC ratio \<70%, and clinically stable at the time of entering the study);
6. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

1. Dry bronchiectasis mainly characterized by hemoptysis;
2. Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;
3. Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);
4. Combined with serious diseases of the heart, liver, kidneys, digestive system, blood system, etc., evaluated by the researcher, including but not limited to acute severe hepatitis, liver failure, liver cirrhosis, acute renal failure, acute myocardial infarction, heart failure, gastric perforation, gastrointestinal bleeding, gastric cancer, intestinal cancer, acute leukemia, acute aplastic anemia, etc., subject to the judgment of the researcher;
5. Abnormal liver function was found in the patient screening examination, with the following criteria: total bilirubin \> 1.5×ULN; ALT \> 3×ULN; AST \> 3×ULN;
6. Inability to swallow the research drug;
7. Known allergy to the test drug;
8. Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization;
9. Women or men of childbearing age refused to use contraceptive measures during the study period;
10. Pregnant or lactating women;
11. Any other factors that may not be suitable for participation in clinical research as determined by the researcher;
12. In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse;
13. Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period.

Where this trial is running

Hangzhou, Zhejiang and 4 other locations

• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Huzhou Central Hospital — Huzhou, Zhejiang, China (Not_yet_recruiting)
• Jinhua Central Hospital — Jinhua, Zhejiang, China (Not_yet_recruiting)
• Yueqing People's Hospital — Yueqing, Zhejiang, China (Not_yet_recruiting)
• Zhoushan Hospital — Zhoushan, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Haibin Dai

Conditions Bronchiectasis; COPD