About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Low-dose H057+standard-of-care
- High-dose H057+standard-of-care
- H057 placebo+standard-of-care