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.
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;
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;
Parallel
Low-dose H057+standard-of-care
DrugSubjects 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
DrugSubjects 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
DrugSubjects 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.
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.
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.
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.
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).
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.
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