A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Inhaled H057 in the Treatment of Acute Exacerbations of Bronchiectasis

NCT06958861 | Not Yet Recruiting Phase 2

• 1 other identifier: PH-H057-II-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 19

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.

Conditions

Acute Exacerbations of Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to day 15

Secondary Outcomes (16)

• Quality-of-Life Bronchiectasis Respiratory Symptom Score

  baseline to day 29 or day 1 post-treatment

• treatment efficacy rate

  baseline to day 15

• clinical pulmonary infection score

  baseline to day 15

• bronchiectasis exacerbation and symptom tool

  baseline to day 29 or day 1 post-treatment

• Borg Scale

  baseline to day 29 or day 1 post-treatment

Study Arms (3)

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.

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.

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.

Drug: H057 placebo+standard-of-care

Interventions

Low-dose H057+standard-of-care DRUG

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.

Low dose H057+standard-of-care

High-dose H057+standard-of-care DRUG

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.

High dose H057+standard-of-care

H057 placebo+standard-of-care DRUG

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.

H057 placebo+standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Shanghai Huilun Pharmaceutical Co., Ltd.: lead

Study Sites (19)

Fuyang Hospital Of Anhui Medical University

Fuyang, Anhui, China

Location

Hefei First People's Hospital

Hefei, Anhui, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Affiliated hospital of Youjiang Medical University For Nationalities

Baise City, Guangxi, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, China

Location

Nanyang Second General Hospital

Nanyang, Henan, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Yichang Central People's Hospital

Yichang, Hubei, China

Location

The second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Location

Jiujiang No.1 People's Hospital

Jiujiang, Jiangxi, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

Deyang People's Hospital

Deyang, Sichuan, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Location

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Central Study Contacts

Zhanyang Zhu

CONTACT

86-021-64311017; clinical_trial@hllife.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

CN (19)