Bronchiectasis With Acute ExacerbationNCT07813299
Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled Trial
A study testing Bronchoalveolar Lavage and Local Amikacin Injection and Bronchoalveolar Lavage in people with Bronchiectasis With Acute Exacerbation, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
Bronchiectasis is a chronic respiratory system disease characterized by irreversible structural dilation of the bronchi, persistent cough, and alternating periods of stability and acute exacerbation during the clinical course. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis With Acute Exacerbation
- What is being tested?
- Bronchoalveolar Lavage and Local Amikacin Injection and Bronchoalveolar Lavage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 15 May 2028
- Phase
- Interventional
- 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
- Aged between 18 and 80 years, inclusive.
- According to the adult bronchiectasis guidelines, diagnosed with bronchiectasis, and indicating lesions accumulating in 2 or more lung lobes.
- Presenting with an acute exacerbation, defined by worsening of key symptoms (e.g., cough, sputum volume, dyspnea, chest tightness, or wheezing), and willing to undergo bronchoscopy with bronchoalveolar lavage (BAL).
- Patients who are alert, cooperative, and able to tolerate the bronchoscopic procedure.
- Provided written informed consent to participate in this clinical trial.
Who cannot join
- Presence of severe comorbidities or any contraindications to flexible bronchoscopy.
- Intraoperative oxygen desaturation (SpO₂) or inability to tolerate bronchoalveolar lavage (BAL) following bronchoscopic insertion.
- Declined participation or was deemed ineligible by the investigator for other reasons.
- Coagulopathy (platelet count < 50 × 10⁹/L) or active airway bleeding observed during bronchoscopy, posing a potential risk of exacerbation from BAL.
- Incomplete procedural documentation or missing follow-up data.
- Known allergy or hypersensitivity to amikacin.
- Concurrent renal failure.
- Diagnosis of cystic fibrosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010
Zhongbo Chen, +8613777125910, leonczb@163.com
About this study
Bronchiectasis is a chronic respiratory system disease characterized by irreversible structural dilation of the bronchi, persistent cough, and alternating periods of stability and acute exacerbation during the clinical course. Although airway clearance techniques (ACTs) are widely recommended, some hospitalized patients are unable to fully participate in conventional physical therapy due to respiratory difficulties or impaired sputum clearance. Bronchoscopic airway clearance therapy (B-ACT), combined with bronchoalveolar lavage under direct bronchoscopic visualization, can remove airway secretions. Previous studies have shown that bronchoscopy-guided airway clearance therapy (B-ACT) may prolong the time from discharge to the first exacerbation. In China, there have been studies exploring the use of bronchoscopy-guided alveolar lavage combined with local application of amikacin to treat patients with bronchiectasis. This study aims to explore whether the local application of amikacin after bronchoscopy-guided saline alveolar lavage provides greater benefits for patients with acute exacerbation of bronchiectasis compared to conventional treatment (non-bronchoscopy lavage) and bronchoscopy-guided saline alveolar lavage. The goal is to apply this treatment method in clinical practice to reduce the frequency of acute exacerbations in patients with bronchiectasis, improve prognosis, and enhance quality of life.
Read the detailed description
All enrolled patients are in the acute exacerbation phase of bronchiectasis. A total of 186 patients with acute exacerbation of bronchiectasis (1:1:1 allocation) who are willing to participate in this study and sign an informed consent form will be enrolled. The patients will be divided into three groups: Control Group A (based on routine clinical treatment, including anti-infection and expectorant therapy), Control Group B (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline), and Research Group C (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline, followed by local injection of a mixture formed by adding 2 vials of Amikacin (specification: 0.2g/2ml) to 20ml of saline into the target bronchiectasis area).
- Conditions
- Bronchiectasis With Acute Exacerbation
- Being tested
- Bronchoalveolar Lavage and Local Amikacin Injection, Bronchoalveolar Lavage
- Keywords
- bronchiectasis, Amikacin, bronchoalveolar lavage, Bronchoscopic airway clearance therapy
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar Lavage and Local Amikacin InjectionProcedure or surgery
While routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area.
Bronchoalveolar LavageProcedure or surgery
While routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Not described |
| Group B | Other | While routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline. Receives: Procedure: Bronchoalveolar Lavage |
| Group C | Experimental | While routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area. Receives: Procedure: Bronchoalveolar Lavage and Local Amikacin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of first acute exacerbation
Length of post-treatment time points to first acute exacerbation (days) in all three groups of patients.
Measured: six months
Secondary outcomes (6)
The change of mMRC scores
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.
Measured: one month]
The change of CAT scores
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.
Measured: one month
The change of LCQ scores
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.
Measured: one month
The change of SGQR scores
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.
Measured: one month
adverse effects
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.
Measured: one month
Re-treatment with bronchoalveolar lavage
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).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 May 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis With Acute ExacerbationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients were divided into three groups: Control Group A (based on routine clinical treatment, including anti-infection and expectorant therapy), Control Group B (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy), and Research Group C (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy; after lavage, a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) added to 20ml of saline was locally injected into the target bronchiectasis area).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Collaborators
- Anhui Chest Hospital, Ninghai First Hospital, Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813299
- Sponsor's protocol ID
- 2025-R066-03
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhong NS, Qiu R, Cao J, Huang YM, Zhou H, Xu XX, Xu JF, Ye H, Yang ZR, Gao LY, Shen Y, Xiao ZK, Xie SG, Lin DJ, Zhao L, Xiong H, Zhang XM, Li FQ, Guan WJ, Chalmers JD; SAVE-BE trial investigators. Effects of the DPP-1 inhibitor HSK31858 in adults with bronchiectasis in China (SAVE-BE): a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2025 May;13(5):414-424. doi: 10.1016/S2213-2600(25)00019-0. Epub 2025 Mar 25.
PubMed 40154523Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.
PubMed 26882271
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07813299
- Acronym / sponsor ID
- 2025-R066-03
- Conditions
- Bronchiectasis With Acute Exacerbation
- Keywords
- bronchiectasis, Amikacin, bronchoalveolar lavage, Bronchoscopic airway clearance therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Collaborators
- Anhui Chest Hospital, Ninghai First Hospital, Ningbo Municipal Hospital of Traditional Chinese Medicine (TCM), Affiliated Hospital of Zhejiang Chinese Medical University
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 10 Sep 2026 (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.
Bronchiectasis is a chronic respiratory system disease characterized by irreversible structural dilation of the bronchi, persistent cough, and alternating periods of stability and acute exacerbation during the clinical course. Although airway clearance techniques (ACTs) are widely recommended, some hospitalized patients are unable to fully participate in conventional physical therapy due to respiratory difficulties or impaired sputum clearance. Bronchoscopic airway clearance therapy (B-ACT), combined with bronchoalveolar lavage under direct bronchoscopic visualization, can remove airway secretions. Previous studies have shown that bronchoscopy-guided airway clearance therapy (B-ACT) may prolong the time from discharge to the first exacerbation. In China, there have been studies exploring the use of bronchoscopy-guided alveolar lavage combined with local application of amikacin to treat patients with bronchiectasis. This study aims to explore whether the local application of amikacin after bronchoscopy-guided saline alveolar lavage provides greater benefits for patients with acute exacerbation of bronchiectasis compared to conventional treatment (non-bronchoscopy lavage) and bronchoscopy-guided saline alveolar lavage. The goal is to apply this treatment method in clinical practice to reduce the frequency of acute exacerbations in patients with bronchiectasis, improve prognosis, and enhance quality of life.
Detailed description
All enrolled patients are in the acute exacerbation phase of bronchiectasis. A total of 186 patients with acute exacerbation of bronchiectasis (1:1:1 allocation) who are willing to participate in this study and sign an informed consent form will be enrolled. The patients will be divided into three groups: Control Group A (based on routine clinical treatment, including anti-infection and expectorant therapy), Control Group B (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline), and Research Group C (in addition to routine use of antibacterial and expectorant medications, using bronchoscopy to wash the affected lung lobe with 180ml of saline, followed by local injection of a mixture formed by adding 2 vials of Amikacin (specification: 0.2g/2ml) to 20ml of saline into the target bronchiectasis area).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The patients were divided into three groups: Control Group A (based on routine clinical treatment, including anti-infection and expectorant therapy), Control Group B (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy), and Research Group C (in addition to routine use of antibacterial and expectorant medications, 180ml of saline was used to lavage the affected lung lobe under bronchoscopy; after lavage, a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) added to 20ml of saline was locally injected into the target bronchiectasis area).
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | – |
| Group B | Other | Procedure: Bronchoalveolar LavageWhile routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline. |
| Group C | Experimental | Procedure: Bronchoalveolar Lavage and Local Amikacin InjectionWhile routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 80 years, inclusive.
- According to the adult bronchiectasis guidelines, diagnosed with bronchiectasis, and indicating lesions accumulating in 2 or more lung lobes.
- Presenting with an acute exacerbation, defined by worsening of key symptoms (e.g., cough, sputum volume, dyspnea, chest tightness, or wheezing), and willing to undergo bronchoscopy with bronchoalveolar lavage (BAL).
- Patients who are alert, cooperative, and able to tolerate the bronchoscopic procedure.
- Provided written informed consent to participate in this clinical trial.
Key exclusion criteria (8 listed)
- Presence of severe comorbidities or any contraindications to flexible bronchoscopy.
- Intraoperative oxygen desaturation (SpO₂) or inability to tolerate bronchoalveolar lavage (BAL) following bronchoscopic insertion.
- Declined participation or was deemed ineligible by the investigator for other reasons.
- Coagulopathy (platelet count < 50 × 10⁹/L) or active airway bleeding observed during bronchoscopy, posing a potential risk of exacerbation from BAL.
- Incomplete procedural documentation or missing follow-up data.
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 |
|---|---|---|
| Bronchoalveolar Lavage and Local Amikacin InjectionWhile routinely using antibiotics and expectorants for treatment, perform bronchoscopic lavage of the affected lung lobe with 180ml of saline; after lavage, locally inject a mixture of 2 vials of Amikacin (specification: 0.2g/2ml) mixed with 20ml of saline into the target bronchiectasis area. | Procedure or surgery | Group C |
| Bronchoalveolar LavageWhile routinely using antibiotics and expectorants for treatment, perform bronchoscopy and lavage the affected lung lobe with 180ml of saline. | Procedure or surgery | Group B |
Primary outcome
Time of first acute exacerbation
Time frame: six months
Length of post-treatment time points to first acute exacerbation (days) in all three groups of patients.
6 secondary outcomes
The change of mMRC scores
Time frame: one month]
The change of CAT scores
Time frame: one month
The change of LCQ scores
Time frame: one month
The change of SGQR scores
Time frame: one month
adverse effects
Time frame: one month
Re-treatment with bronchoalveolar lavage
Time frame: six months
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 10 Sep 2026.
- Results publication: PubMed 40154523Zhong NS, Qiu R, Cao J, Huang YM, Zhou H, Xu XX, Xu JF, Ye H, Yang ZR, Gao LY, Shen Y, Xiao ZK, Xie SG, Lin DJ, Zhao L, Xiong H, Zhang XM, Li FQ, Guan WJ, Chalmers JD; SAVE-BE trial investigators. Effects of the DPP-1 inhibitor HSK31858 in adults with bronchiectasis in China (SAVE-BE): a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2025 May;13(5):414-424. doi: 10.1016/S2213-2600(25)00019-0. Epub 2025 Mar 25.
- Results publication: PubMed 26882271Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis With Acute Exacerbation
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
RecruitingObservational study
Bronchiectasis Phenotype Identification Model
Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
RecruitingObservational study
BASE: Bronchiectasis Severity and Exacerbation Risk Study
Bronchiectasis, Non-cystic Fibrosis 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoalveolar Lavage and Local Amikacin Injection and Bronchoalveolar Lavage in people with Bronchiectasis With Acute Exacerbation, run by First Affiliated Hospital of Ningbo University at 1 site 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 5 inclusion and 8 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Zhongbo Chen (+8613777125910, leonczb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of first acute exacerbation (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813299, which also lists 2 linked publications.
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 10 Sep 2026.