Clinical trial NCT06958861: A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Exacerbations of Bronchiectasis
Lead sponsor: Shanghai Huilun Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for enrollment in this study:

1. Age ≥18 years, regardless of gender;
2. 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;
3. Able to tolerate nebulized inhalation treatment;
4. After instruction, able to correctly use the nebulizer for treatment and accurately complete questionnaires;
5. 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.

Exclusion Criteria:

If a subject meets any of the following criteria, they are not eligible to participate in this study:

1. Patients with bronchiectasis caused by cystic fibrosis, as determined by the investigator;
2. Patients who have experienced an acute exacerbation of bronchiectasis for more than 7 days;
3. Patients with an acute exacerbation of bronchiectasis who have received intravenous antibiotic treatment for more than 72 hours prior to enrollment;
4. Patients with mild bronchiectasis caused by asthma;
5. Patients with comorbid allergic bronchopulmonary aspergillosis, active tuberculosis, or active non-tuberculous mycobacterial infection requiring standardized treatment;
6. 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);
7. Patients with significant liver or kidney dysfunction (ALT, AST \>2 times the upper limit of normal \[ULN\]; Cr \>1.5 times ULN);
8. Patients with a history of malignancy or who have achieved clinical remission for less than 5 years;
9. 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;
10. 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;
11. 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;
12. Patients who have participated in other drug or medical device trials within the past 3 months or are currently participating in another clinical trial;
13. Pregnant women, lactating women, and women of childbearing potential;
14. Subjects whom the investigator considers unsuitable for participation in this study for any reason.

Primary outcomes:
measure: Quality-of-Life Bronchiectasis Respiratory Symptom Score
timeFrame: baseline to day 15
Secondary outcomes:
measure: Quality-of-Life Bronchiectasis Respiratory Symptom Score
timeFrame: baseline to day 29 or day 1 post-treatment
measure: treatment efficacy rate
timeFrame: baseline to day 15
measure: clinical pulmonary infection score
timeFrame: baseline to day 15
measure: bronchiectasis exacerbation and symptom tool
timeFrame: baseline to day 29 or day 1 post-treatment
measure: Borg Scale
timeFrame: baseline to day 29 or day 1 post-treatment
measure: sputum purulence score
timeFrame: baseline to day 29 or day 1 post-treatment
measure: 24-hour sputum volume
timeFrame: baseline to day 29 or day 1 post-treatment
measure: FEV1%pred
timeFrame: baseline to day 29 or day 1 post-treatment
measure: the frequency of acute exacerbations in bronchiectasis
timeFrame: day 1 to day 180
measure: safety of inhaled H057 in acute exacerbations of bronchiectasis
timeFrame: day 1 to day 180
measure: pharmacokinetic characteristics--Cmax
timeFrame: day 1 to day 28
measure: pharmacokinetic characteristics--Tmax
timeFrame: day 1 to day 28
measure: pharmacokinetic characteristics--t1/2
timeFrame: day 1 to day 28
measure: pharmacokinetic characteristics--AUC0-t
timeFrame: day 1 to day 28
measure: pharmacokinetic characteristics--Rac
timeFrame: day 1 to day 28
measure: pharmacodynamic characteristic
timeFrame: day 1 to day 28
Other outcomes:
Locations:
city: Fuyang
country: China
facility: Fuyang Hospital Of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: Hefei First People's Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Baise
country: China
facility: Affiliated hospital of Youjiang Medical University For Nationalities
state: Guangxi Zhuang Autonomous Region
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Nanyang
country: China
facility: Nanyang Second General Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou First People's Hospital
state: Jiangsu
city: Jiujiang
country: China
facility: Jiujiang No.1 People's Hospital
state: Jiangxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Deyang
country: China
facility: Deyang People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo No.2 Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: