BronchiectasisPhase 4NCT07114120
Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules
A Phase 4 study testing Bailing Capsules in combination Guben Kechuan Granules in people with Bronchiectasis and COPD, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
The goal of this clinical trial is to learn if Bailing Capsules in combination Guben Kechuan Granules works to treat stable bronchiectasis in adults.It will also learn about the safety of Bailing Capsules in combination Guben Kechuan Granules The main questions it aims to answer are: Does Bailing Capsules in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis, COPD
- What is being tested?
- Bailing Capsules in combination Guben Kechuan Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 5 sitesChina
- Study dates
- 14 Jul 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old, gender not limited;
- It conforms to the Western medical diagnosis of bronchiectasis;
- 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);
- 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;
- 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);
- Voluntarily participate in this clinical trial and sign the informed consent form.
Who cannot join
- Dry bronchiectasis mainly characterized by hemoptysis;
- Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;
- Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);
- 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;
- 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;
- Inability to swallow the research drug;
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- Known allergy to the test drug;
- Participate in other clinical trials, use other research drugs or research devices within 30 days before randomization;
- Women or men of childbearing age refused to use contraceptive measures during the study period;
- Pregnant or lactating women;
- Any other factors that may not be suitable for participation in clinical research as determined by the researcher;
- In the past year, there has been a history of alcohol abuse, drug abuse or drug abuse;
- Other traditional Chinese medicine treatments were used within 7 days before the use of the study drug and during the study period.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Haibin Dai, 0571-87783759, HREC2013@126.com
- Not yet recruiting
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Wei Zhang
- Not yet recruiting
Jinhua Central Hospital
Jinhua, Zhejiang, 321000
Junwei Tu
- Not yet recruiting
Yueqing People's Hospital
Yueqing, Zhejiang, 325600
Jifa Li
- Not yet recruiting
Zhoushan Hospital
Zhoushan, Zhejiang, 316000
Huaiyu Zheng
About this study
The goal of this clinical trial is to learn if Bailing Capsules in combination Guben Kechuan Granules works to treat stable bronchiectasis in adults.It will also learn about the safety of Bailing Capsules in combination Guben Kechuan Granules The main questions it aims to answer are:
Does Bailing Capsules in combination Guben Kechuan Granules lower the number of acute exacerbation in patients with stable bronchiectasis? The safety of the combination of Bailing Capsules and Guben Kechuan Granules ? Researchers will compare the combination of Bailing Capsules and Guben Kechuan Granules to standard Western medical treatment to see if them works to treat stable bronchiectasis.
Read more
Participants will:
Take Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules ( three times a day, 1 bag each time )on the basis of standard Western medical treatment or only standard Western medical treatment for 24 weeks Visit the clinic for checkups and tests on 4, 12, 24, 48 weeks Keep a diary of their symptoms
- Conditions
- Bronchiectasis, COPD
- Being tested
- Bailing Capsules in combination Guben Kechuan Granules
- Medical subject headings
- Bronchiectasis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bailing Capsules in combination Guben Kechuan GranulesDrug
Also called Bailing Capsules, Guben Kechuan Granules
Bailing Capsules (four capsules each time, three times a day) in combination Guben Kechuan Granules (1 bag each time，three times a day,)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules (1 bag each time, three times a day) on the basis of standard Western medical treatment Receives: Drug: Bailing Capsules in combination Guben Kechuan Granules |
| Control group | No intervention | standard Western medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of acute exacerbations during treatment and follow-up
Measured: 24 weeks and 48 weeks
Secondary outcomes (4)
Pulmonary function
FVC
Measured: 12, 24, 48 weeks
Pulmonary function
FEV1
Measured: 12, 24, 48 weeks
Pulmonary function
FEV1/FVC
Measured: 12, 24 48 weeks
Pulmonary function
TLC
Measured: 12, 24, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start14 Jul 2025
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZhuZhou Central Hospital, Jinhua Central Hospital, Shanghai Zhongshan Hospital, Affiliated Yueqing Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114120
- Sponsor's protocol ID
- 2025-0537
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Stable Bronchiectasis With Bailing Capsules Combined With Guben Kechuan Granules
- ClinicalTrials.gov ID
- NCT07114120
- Acronym / sponsor ID
- 2025-0537
- Conditions
- Bronchiectasis, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- ZhuZhou Central Hospital, Jinhua Central Hospital, Shanghai Zhongshan Hospital, Affiliated Yueqing Hospital of Wenzhou Medical University
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Bailing Capsules in combination Guben Kechuan Granules works to treat stable bronchiectasis in adults.It will also learn about the safety of Bailing Capsules in combination Guben Kechuan Granules The main questions it aims to answer are:
Does Bailing Capsules in combination Guben Kechuan Granules lower the number of acute exacerbation in patients with stable bronchiectasis? The safety of the combination of Bailing Capsules and Guben Kechuan Granules ? Researchers will compare the combination of Bailing Capsules and Guben Kechuan Granules to standard Western medical treatment to see if them works to treat stable bronchiectasis.
Participants will:
Take Bailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules ( three times a day, 1 bag each time )on the basis of standard Western medical treatment or only standard Western medical treatment for 24 weeks Visit the clinic for checkups and tests on 4, 12, 24, 48 weeks Keep a diary of their symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Bailing Capsules in combination Guben Kechuan GranulesBailing Capsules orally (four capsules each time, three times a day) and Guben Kechuan Granules (1 bag each time, three times a day) on the basis of standard Western medical treatment |
| Control group | No intervention | –standard Western medical treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years old, gender not limited;
- It conforms to the Western medical diagnosis of bronchiectasis;
- 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);
- 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;
- 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);
Key exclusion criteria (13 listed)
- Dry bronchiectasis mainly characterized by hemoptysis;
- Bronchiectasis caused by cystic fibrosis, allergic bronchopulmonary aspergillosis, etc;
- Previous respiratory diseases other than bronchiectasis (such as bronchial asthma, lung cancer, active pulmonary tuberculosis, interstitial lung disease, pulmonary thromboembolism and severe pneumonia, etc.);
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bailing Capsules in combination Guben Kechuan GranulesAlso: Bailing Capsules, Guben Kechuan GranulesBailing Capsules (four capsules each time, three times a day) in combination Guben Kechuan Granules (1 bag each time，three times a day,) | Drug | Experimental group |
Primary outcome
The number of acute exacerbations during treatment and follow-up
Time frame: 24 weeks and 48 weeks
4 secondary outcomes
Pulmonary function
Time frame: 12, 24, 48 weeks
Pulmonary function
Time frame: 12, 24, 48 weeks
Pulmonary function
Time frame: 12, 24 48 weeks
Pulmonary function
Time frame: 12, 24, 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bailing Capsules in combination Guben Kechuan Granules in people with Bronchiectasis and COPD, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haibin Dai (（0571）87783759, haibindai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of acute exacerbations during treatment and follow-up (time frame: 24 weeks and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.