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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
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.
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.
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.
Fuyang Hospital Of Anhui Medical University
Fuyang, Anhui, China
Hefei First People's Hospital
Hefei, Anhui, China
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.
Time frame: baseline to day 15
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.
Time frame: 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.
Time frame: 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).
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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
...and 9 more locations
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: baseline to day 29 or day 1 post-treatment
24-hour sputum volume
To evaluate change in 24-hour sputum volume from baseline
Time frame: baseline to day 29 or day 1 post-treatment
FEV1%pred
To evaluate change in FEV1%pred from baseline
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
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.
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
To evaluate change in neutrophil elastase levels from baseline
Time frame: day 1 to day 28