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NOT YET RECRUITING
NCT06958861
PHASE2

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

Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-05

Completion Date

2027-05

Last Updated

2025-05-09

Healthy Volunteers

No

Interventions

DRUG

Low-dose H057+standard-of-care

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

High-dose H057+standard-of-care

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

H057 placebo+standard-of-care

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.

Locations (19)

Fuyang Hospital Of Anhui Medical University

Fuyang, Anhui, China

Hefei First People's Hospital

Hefei, Anhui, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Affiliated hospital of Youjiang Medical University For Nationalities

Baise City, Guangxi, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Nanyang Second General Hospital

Nanyang, Henan, China

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

Wuhan, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

The second Xiangya Hospital of Central South University

Changsha, Hunan, China

Changzhou First People's Hospital

Changzhou, Jiangsu, China

Jiujiang No.1 People's Hospital

Jiujiang, Jiangxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Deyang People's Hospital

Deyang, Sichuan, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China