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

NCT06715956 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-12-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-11-01
Completion
2027-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715956 on ClinicalTrials.gov