Acute Exacerbations of BronchiectasisPhase 2NCT06958861
A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
A Phase 2 study testing Low-dose H057+standard-of-care and High-dose H057+standard-of-care in people with Acute Exacerbations of Bronchiectasis, run by Shanghai Huilun Pharmaceutical Co., Ltd. at 19 sites in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of inhaled H057 in the treatment of acute exacerbations of bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Exacerbations of Bronchiectasis
- What is being tested?
- Low-dose H057+standard-of-care and High-dose H057+standard-of-care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 19 sitesChina
- Study dates
- May 2025to May 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for enrollment in this study:
- Age ≥18 years, regardless of gender;
- Patients who are determined by the investigator to be in an acute exacerbation phase of bronchiectasis prior to enrollment: at least three out of the following six symptoms-cough, changes in sputum volume, purulent sputum, dyspnea or reduced exercise tolerance, fatigue or malaise, hemoptysis-have worsened for more than 48 hours, and the clinician deems that intervention is necessary;
- Able to tolerate nebulized inhalation treatment;
- After instruction, able to correctly use the nebulizer for treatment and accurately complete questionnaires;
- Subjects must fully understand the purpose, nature, methods, and potential adverse events of the trial, voluntarily agree to participate, and sign the informed consent form, or have a legally authorized representative provide informed consent on their behalf.
Who cannot join
- If a subject meets any of the following criteria, they are not eligible to participate in this study:
- Patients with bronchiectasis caused by cystic fibrosis, as determined by the investigator;
- Patients who have experienced an acute exacerbation of bronchiectasis for more than 7 days;
- Patients with an acute exacerbation of bronchiectasis who have received intravenous antibiotic treatment for more than 72 hours prior to enrollment;
- Patients with mild bronchiectasis caused by asthma;
- Patients with comorbid allergic bronchopulmonary aspergillosis, active tuberculosis, or active non-tuberculous mycobacterial infection requiring standardized treatment;
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- Patients with moderate or massive hemoptysis during an acute exacerbation of bronchiectasis (moderate hemoptysis: 100-500 mL within 24 hours; massive hemoptysis: >500 mL within 24 hours or a single episode of 100-500 mL);
- Patients with significant liver or kidney dysfunction (ALT, AST >2 times the upper limit of normal [ULN]; Cr >1.5 times ULN);
- Patients with a history of malignancy or who have achieved clinical remission for less than 5 years;
- Patients with any other unstable clinical conditions deemed significant by the investigator, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physiological dysfunction, and: a) Whose condition may affect the patient's safety during the study; b) That may impact the study results and their interpretation; c) That may hinder the patient's ability to complete the entire study;
- Patients who are positive for hepatitis B surface antigen (HBsAg) with HBV-DNA >1000 copies/mL or 200 IU/mL, or positive for hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or anti-Treponema pallidum antibody;
- Patients who are allergic to the active ingredients or excipients of the investigational product or who have a history of hypersensitivity or an allergic constitution;
- Patients who have participated in other drug or medical device trials within the past 3 months or are currently participating in another clinical trial;
- Pregnant women, lactating women, and women of childbearing potential;
- Subjects whom the investigator considers unsuitable for participation in this study for any reason.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites
Affiliated hospital of Youjiang Medical University For Nationalities
Baise City, Guangxi
Yujie Jiang
Yujie Jiang
The second Xiangya Hospital of Central South University
Changsha, Hunan
Hong Luo
Hong Luo
Changzhou First People's Hospital
Changzhou, Jiangsu
Chong Li
Chong Li
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Lingyun Gao
Lingyun Gao
Deyang People's Hospital
Deyang, Sichuan
Chunfang Zeng
Chunfang Zeng
Fuyang Hospital Of Anhui Medical University
Fuyang, Anhui
Lei Zhao
Lei Zhao
Fujian Medical University Union Hospital
Fuzhou, Fujian
Xiangqi Chen
Xiangqi Chen
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Nanshan Zhong, 86-020-83062893, nanshan@vip.163.com
Weijie Guan, 86-13826042052, battery203@163.com
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Limin Wang
Limin Wang
Hefei First People's Hospital
Hefei, Anhui
Zhen Ding
Zhen Ding
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
Dan Zhu
Dan Zhu
Jiujiang No.1 People's Hospital
Jiujiang, Jiangxi
Jun Li
Jun Li
Nanyang Second General Hospital
Nanyang, Henan
Fengling Ju
Fengling Ju
Ningbo No.2 Hospital
Ningbo, Zhejiang
Zhaoxing Dong
Zhaoxing Dong
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Ruilin Sun
Ruilin Sun
Hebei General Hospital
Shijiazhuang, Hebei
Li Yan
Li Yan
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xiaoying Huang
Xiaoying Huang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaorong Wang
Xiaorong Wang
Yichang Central People's Hospital
Yichang, Hubei
Xinyu Song
Xinyu Song
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
This is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of inhaled H057 in the treatment of acute exacerbations of bronchiectasis.
- Conditions
- Acute Exacerbations of Bronchiectasis
- Being tested
- Low-dose H057+standard-of-care, High-dose H057+standard-of-care, H057 placebo+standard-of-care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose H057+standard-of-careDrug
Subjects are administered low-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
High-dose H057+standard-of-careDrug
Subjects are administered high-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
H057 placebo+standard-of-careDrug
Subjects are administered inhaled H057 placebo, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures.
| Study group | Role | What they receive |
|---|---|---|
| Low dose H057+standard-of-care | Experimental | Subjects are administered low-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. Receives: Drug: Low-dose H057+standard-of-care |
| High dose H057+standard-of-care | Experimental | Subjects are administered high-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. Receives: Drug: High-dose H057+standard-of-care |
| H057 placebo+standard-of-care | Placebo comparator | Subjects are administered inhaled H057 placebo, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. Receives: Drug: H057 placebo+standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-of-Life Bronchiectasis Respiratory Symptom Score
To evaluate change in Quality-of-Life Bronchiectasis Respiratory Symptom Score (QoL-B-RSS) from baseline.
QoL-B-RSS, a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). It scores ranging from 0 to 100, where lower scores indicated more severe symptoms.
Measured: baseline to day 15
Secondary outcomes (16)
Quality-of-Life Bronchiectasis Respiratory Symptom Score
To evaluate change in Quality-of-Life Bronchiectasis Respiratory Symptom Score (QoL-B-RSS) from baseline.
QoL-B-RSS, a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). It scores ranging from 0 to 100, where lower scores indicated more severe symptoms.
Measured: baseline to day 29 or day 1 post-treatment
treatment efficacy rate
Response to treatment is defined as the significant improvement or near resolution of acute exacerbation symptoms.
Treatment failure is defined as the absence of significant improvement or progressive worsening of acute exacerbation symptoms, such as requiring hospitalization or the need for additional antibiotic therapy.
Measured: baseline to day 15
clinical pulmonary infection score
To evaluate change in clinical pulmonary infection score (CPIS) from baseline. The CPIS is calculated on the basis of points assigned for various signs and symptoms of pneumonia (eg, fever and extent of oxygenation impairment). It scores ranging from 0 to 12, where higher scores mean a worse outcome. Some studies suggest that a CPIS >6 may correlate with ventilator-associated pneumonia (VAP).
Measured: baseline to day 15
bronchiectasis exacerbation and symptom tool
To evaluate change in bronchiectasis exacerbation and symptom tool (BEST) from baseline.
The BEST diary is to detect bronchiectasis exacerbations. It scores ranging from 0 to 26, where higher scores indicate more severe symptoms.The BEST symptom diary is responsive at onset and recovery from exacerbation and may be useful to capture and characterise exacerbations.
Measured: baseline to day 29 or day 1 post-treatment
Borg Scale
To evaluate change in Borg Scale from baseline. Borg Scale is one of commonly used measures to assess dyspnea in chronic lung disease.The scale was modified to form a 10-point scale including written indicators of severity. The scale has been used to quantify various "perceived symptoms" such as breathlessness and muscle fatigue during exercise. The higher Borg Scale means more severe breathlessness and muscle fatigue
Measured: baseline to day 29 or day 1 post-treatment
sputum purulence score
To evaluate change in sputum purulence score from baseline. It scores ranging from 0 to 8, where a higher score indicates greater severity of the condition.
Measured: baseline to day 29 or day 1 post-treatment
24-hour sputum volume
To evaluate change in 24-hour sputum volume from baseline
Measured: baseline to day 29 or day 1 post-treatment
FEV1%pred
To evaluate change in FEV1%pred from baseline
Measured: baseline to day 29 or day 1 post-treatment
the frequency of acute exacerbations in bronchiectasis
Measured: day 1 to day 180
safety of inhaled H057 in acute exacerbations of bronchiectasis
the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and laboratory test results, etc.
Measured: day 1 to day 180
pharmacokinetic characteristics--Cmax
Measured: day 1 to day 28
pharmacokinetic characteristics--Tmax
Measured: day 1 to day 28
pharmacokinetic characteristics--t1/2
Measured: day 1 to day 28
pharmacokinetic characteristics--AUC0-t
Measured: day 1 to day 28
pharmacokinetic characteristics--Rac
Measured: day 1 to day 28
pharmacodynamic characteristic
To evaluate change in neutrophil elastase levels from baseline
Measured: day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbations of BronchiectasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958861
- Sponsor's protocol ID
- PH-H057-II-03
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
- ClinicalTrials.gov ID
- NCT06958861
- Acronym / sponsor ID
- PH-H057-II-03
- Conditions
- Acute Exacerbations of Bronchiectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 May 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.
This is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of inhaled H057 in the treatment of acute exacerbations of bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose H057+standard-of-care | Experimental | Drug: Low-dose H057+standard-of-careSubjects are administered low-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. |
| High dose H057+standard-of-care | Experimental | Drug: High-dose H057+standard-of-careSubjects are administered high-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. |
| H057 placebo+standard-of-care | Placebo comparator | Drug: H057 placebo+standard-of-careSubjects are administered inhaled H057 placebo, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following criteria to be eligible for enrollment in this study:
- Age ≥18 years, regardless of gender;
- Patients who are determined by the investigator to be in an acute exacerbation phase of bronchiectasis prior to enrollment: at least three out of the following six symptoms-cough, changes in sputum volume, purulent sputum, dyspnea or reduced exercise tolerance, fatigue or malaise, hemoptysis-have worsened for more than 48 hours, and the clinician deems that intervention is necessary;
- Able to tolerate nebulized inhalation treatment;
- After instruction, able to correctly use the nebulizer for treatment and accurately complete questionnaires;
Key exclusion criteria (15 listed)
- If a subject meets any of the following criteria, they are not eligible to participate in this study:
- Patients with bronchiectasis caused by cystic fibrosis, as determined by the investigator;
- Patients who have experienced an acute exacerbation of bronchiectasis for more than 7 days;
- Patients with an acute exacerbation of bronchiectasis who have received intravenous antibiotic treatment for more than 72 hours prior to enrollment;
- Patients with mild bronchiectasis caused by asthma;
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 |
|---|---|---|
| Low-dose H057+standard-of-careSubjects are administered low-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. | Drug | Low dose H057+standard-of-care |
| High-dose H057+standard-of-careSubjects are administered high-dose inhaled H057, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. | Drug | High dose H057+standard-of-care |
| H057 placebo+standard-of-careSubjects are administered inhaled H057 placebo, combined with standard-of-care treatment, which included anti-infective therapy, expectorant therapy, hemostasis, oxygen therapy, and other supportive measures. | Drug | H057 placebo+standard-of-care |
Primary outcome
Quality-of-Life Bronchiectasis Respiratory Symptom Score
Time frame: baseline to day 15
To evaluate change in Quality-of-Life Bronchiectasis Respiratory Symptom Score (QoL-B-RSS) from baseline. QoL-B-RSS, a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis, contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). It scores ranging from 0 to 100, where lower scores indicated more severe symptoms.
16 secondary outcomes
Quality-of-Life Bronchiectasis Respiratory Symptom Score
Time frame: baseline to day 29 or day 1 post-treatment
treatment efficacy rate
Time frame: baseline to day 15
clinical pulmonary infection score
Time frame: baseline to day 15
bronchiectasis exacerbation and symptom tool
Time frame: baseline to day 29 or day 1 post-treatment
Borg Scale
Time frame: baseline to day 29 or day 1 post-treatment
sputum purulence score
Time frame: baseline to day 29 or day 1 post-treatment
24-hour sputum volume
Time frame: baseline to day 29 or day 1 post-treatment
FEV1%pred
Time frame: baseline to day 29 or day 1 post-treatment
the frequency of acute exacerbations in bronchiectasis
Time frame: day 1 to day 180
safety of inhaled H057 in acute exacerbations of bronchiectasis
Time frame: day 1 to day 180
pharmacokinetic characteristics--Cmax
Time frame: day 1 to day 28
pharmacokinetic characteristics--Tmax
Time frame: day 1 to day 28
pharmacokinetic characteristics--t1/2
Time frame: day 1 to day 28
pharmacokinetic characteristics--AUC0-t
Time frame: day 1 to day 28
pharmacokinetic characteristics--Rac
Time frame: day 1 to day 28
pharmacodynamic characteristic
Time frame: day 1 to day 28
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 9 May 2025.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose H057+standard-of-care and High-dose H057+standard-of-care in people with Acute Exacerbations of Bronchiectasis, run by Shanghai Huilun Pharmaceutical Co., Ltd. at 19 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 15 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: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhanyang Zhu (86-021-64311017, clinical_trial@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-of-Life Bronchiectasis Respiratory Symptom Score (time frame: baseline to day 15). 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 9 May 2025.