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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.
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
Conditions
Interventions
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.
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.
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