NCT06715956

Observational Study of Sputum Inflammation Phenotypes and Clinical Outcomes in Non-Cystic Fibrosis Bronchiectasis

A Multicenter, Observational Study to Investigate Sputum Inflammation Phenotyping and Predict Clinical Outcomes in Non-Cystic Fibrosis Bronchiectasis, with Subsequent Participation in the HSK31858 Clinical Trial

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-cystic Fibrosis Bronchiectasis (NCFBE)

Interventions

Type	Name	Description
OTHER	Observational Cohort Classification of Inflammatory Subtypes in Bronchiectasis	This 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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-01
• Completion: 2027-01-01
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: China