A Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of XH-S004 Tablets in Patients With Non-cystic Fibrosis Bronchiectasis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorS-INFINITY Pharmaceuticals Co., Ltd

About this trial

The purpose of this study is to find out if XH-S004 can reduce pulmanary exacerbation over a 24-week treatment duration in participants with non-cystic fibrosis bronchiectasis.

Eligibility criteria

Qualifiers

Understand the procedures and methods of this trial and sign a written informed consent form;

Male or female paticipants aged 18-85 years (inclusive) ;

Chest HRCT shows bronchiectasis affecting one or more lobes, and the condition is clinically diagnosed as non-cystic fibrosis bronchiectasis (clinical manifestations include chronic cough, significant productive cough, and/or intermittent hemoptysis, with or without varying degrees of polypnoea and other symptoms);

Based on medical history and the determination of the investigator , participants have at least 2 documented pulmonary exacerbations in the past 12 months before Screening;

Disqualifiers

Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma

Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency

Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis

Have any acute infections, (including respiratory infections)

Trial design

Treatments tested in this trial

  • XH-S004 20 mg
  • XH-S004 40 mg
  • Placebo

Treatment groups

231 Participants
are divided into 3 treatment groups