What is this study trying to find out about Non-cystic Fibrosis Bronchiectasis?

This study aims to understand the biological pathways and molecular subtypes behind clinical features of non-cystic fibrosis bronchiectasis in Chinese patients. Researchers will analyze biomarkers and genetic data to uncover disease mechanisms. The study is sponsored by AstraZeneca and focuses on improving knowledge about this chronic lung condition.

Who may be eligible for this Non-cystic Fibrosis Bronchiectasis clinical trial?

Adults aged 18 years or older diagnosed with non-cystic fibrosis bronchiectasis and able to perform lung function tests may be eligible. Healthy individuals aged 30 or older without lung disease can also participate as controls. Participants must be stable without recent respiratory infections. Please review eligibility criteria for more details.

Is there any cost to participate in this Non-cystic Fibrosis Bronchiectasis clinical trial?

Study-related care, including all assessments and procedures, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs associated with getting to study visits.

Actively Recruiting

All Genders

Healthy Volunteers

ID07245407

A Multi-center Longitudinal Observation Translational Study to Evaluate Phenotypes, Endotypes and Biomarkers in Chinese Patients With NCFBE

Led by AstraZeneca · Updated on 2026-05-22

320

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Non-cystic fibrosis bronchiectasis (NCFBE) is a chronic lung disease marked by a persistent productive cough and repeated respiratory infections due to permanent widening of the airways. Its prevalence is rising globally, including in China, where patients show unique clinical features compared to Western populations. This study aims to explore the biological pathways and molecular subtypes behind these clinical differences in Chinese NCFBE patients using biomarker assessments and multi-omics analysis. The study involves two groups: up to 300 NCFBE patients aged 18 years or older, including those with recent exacerbations, and at least 20 healthy participants aged 30 years or older without lung disease. Participants will undergo a baseline visit, follow-up visits at 6 and 12 months (including some by phone), and additional visits during exacerbation events. Healthy controls will participate only at baseline and may have an optional bronchoscopy visit. Participants will be monitored through lung function tests, chest imaging, sputum microbiology, gene expression studies, and multiple clinical and quality-of-life assessments over 12 months. The study will gather detailed medical histories, smoking status, and treatment patterns to understand disease pathways and phenotypes. This longitudinal observational study will provide insights into NCFBE progression and molecular characteristics in the Chinese population.

CONDITIONS

Brief Title

A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE

Who Can Participate

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Healthy control participants must be aged 30 years or older with no clinically significant lung disease.
Bronchiectasis participants must be 18 years or older and able to give signed informed consent.
Participants must be able to perform acceptable lung function tests as per ATS/ERS 2019 criteria.
Participants must be able and willing to comply with study requirements, including completing questionnaires and using electronic devices.
Bronchiectasis diagnosis must be confirmed by physician evaluation and chest HRCT scan.
Bronchiectasis patients must be clinically stable at recruitment, with at least 4 weeks since last exacerbation.

You will not qualify if you...

Healthy controls must not have any respiratory diagnosis such as asthma, COPD, bronchiectasis, or pulmonary fibrosis.
Healthy controls must not have inflammatory conditions like rheumatoid arthritis or inflammatory bowel disease.
Active malignancy is excluded except for non-melanoma skin cancer.
Recent antibiotic treatment for respiratory infection or current sinusitis excludes healthy controls.
Contraindications to study procedures including bronchoscopy exclude participation.
Current smokers or those who smoked in the last 3 months are excluded among healthy controls.
Bronchiectasis patients with traction bronchiectasis related to other lung diseases like pulmonary fibrosis or cystic fibrosis are excluded.
Primary diagnosis of other lung diseases such as COPD or asthma excludes bronchiectasis participants unless bronchiectasis is primary.
Participants with unstable major health conditions or recent substance abuse are excluded.
Pregnant or lactating females up to 6 weeks post-partum or cessation of breastfeeding are excluded.
Participants with altered mental status or recent respiratory infection symptoms within 2 weeks are excluded.
Those involved in study planning or conduct, or with terminal illness, are excluded from participation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo baseline assessments including lung function tests, biomarker assessments, and clinical evaluations to characterize their health status and disease features.

1 baseline visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are observed over time with scheduled visits and assessments to track disease progression and clinical outcomes.

1 visit at 6 months (in-person or telephone) and 1 visit at 12 months (in-person), plus unscheduled visits for exacerbation events and 1 optional bronchoscopy visit

Trial Site Locations

Total: 38 locations

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Active, Not Recruiting

Beijing Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

Peking University People's Hospital

Beijing, Beijing Municipality, China

Active, Not Recruiting

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Actively Recruiting

Gansu Provincial Hospital

Lanzhou, Gansu, China

Active, Not Recruiting

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Active, Not Recruiting

Affiliated Hospital of Guangdong Medical University"

Zhanjiang, Guangdong, China

Actively Recruiting

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Actively Recruiting

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Actively Recruiting

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Actively Recruiting

Zhengzhou People's Hospital

Zhengzhou, Henan, China

Actively Recruiting

Shiyan Taihe Hospital

Shiya, Hubei, China

Actively Recruiting

Xiangya Hospital of Central South University

Changsha, Hunan, China

Active, Not Recruiting

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Active, Not Recruiting

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Actively Recruiting

The Second Hospital of Jilin University

Changchun, Jilin, China

Active, Not Recruiting

Weifang People's Hospital

Weifang, Shandong, China

Actively Recruiting

Huadong Hospital Affiliated to Fudan University