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.
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;
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)
Parallel
XH-S004 20 mg
Other interventionAdministered once per day for 24 weeks.
XH-S004 40 mg
Other interventionAdministered once per day for 24 weeks.
Placebo
Other interventionAdministered once per day for 24 weeks.
Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (EMBARC guideline) : 1. Increased cough 2. Increased sputum volume 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis.
Incidence of pulmonary exacerbation as defined by EMBARC over 24-week treatment period.
Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics (EMBARC guideline) : 1. Increased cough 2. Increased sputum volume 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis.
Incidence of Pulmonary exacerbation as defined by investigators over 24-week treatment period.
The definition of pulmonary exacerbation determined by investigator was defined as: Compared with previous symptoms, patient's current symptoms have worsened but not meet the EMBARC guideline-defined criteria for pulmonary exacerbation . However, the invetigator will have determined that oral/IV antibiotic therapy is required.
Change from baseline in forced expiratory volume in 1 second (FEV1) in pulmonary function test at week 24 after first drug administration.
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath.
Change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration;
The QOL-B is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning, and health-related (HR) QOL for participants with non-cystic fibrosis
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