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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Huilun Pharmaceutical Co., Ltd.

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

Treatment groups

180 Participants
are divided into 3 treatment groups