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NCT06715956

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

Sponsor: Guangzhou Institute of Respiratory Disease

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2024-12-01

Completion Date

2027-01-01

Last Updated

2024-12-04

Healthy Volunteers

No

Interventions

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.

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China