This is an observational, multicenter study aimed at investigating the inflammation phenotypes in sputum samples from patients with non-cystic fibrosis bronchiectasis (NCFBE). The study will observe and classify these phenotypes during the clinical screening phase without any intervention. Patients enrolled in this study may later participate in the HSK31858 clinical trial, where they will receive treatment as part of the trial protocol. After the unblinding of the trial, the study will analyze the relationship between sputum inflammation phenotypes and clinical outcomes, including treatment response and prognosis. The goal is to develop a clinical prediction model that incorporates inflammation subtypes to better predict patient outcomes in bronchiectasis.
Age ≥18 years and BMI≥18.0 kg/m² at the time of signing the ICF.
Chest HRCT showed bronchiectasis affecting one or more lobes and was confirmed by a clinician as NCFBE(clinically characterized by chronic cough, expectoration and/or intermittent hemoptysis, with or without shortness of breath and respiratory failure). HRCT was considered effective if the patient had received HRCT in the same hospital within 12 months and screening HRCT is not necessary.
Have at least 2 pulmonary exacerbations in the past 12 months before Screening.
If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable for at least 3 months before the screening visit and throughout the study period.
None
Participants aged 18 years and older with a confirmed diagnosis of non-cystic fibrosis bronchiectasis (NCFBE).
Cohort
Prospective
Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis
Other interventionThis observational study classifies patients with non-cystic fibrosis bronchiectasis into inflammatory subtypes based on sputum analysis. No active treatment or intervention is administered during this observational phase. Participants will later be considered for treatment with HSK31858 as part of an independent clinical trial.
Frequency of pulmonary exacerbations
Time to first pulmonary exacerbation
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
score from 0 to 8
Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
score from 0 to 100
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