Phenotyping and molecular subtyping of Chinese adults with non‑cystic fibrosis bronchiectasis

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

This study will see if blood, sputum and multi-omics tests can identify molecular subtypes in Chinese adults with non-cystic fibrosis bronchiectasis compared with healthy adults.

Quick facts

• Study type: Observational
• Enrollment: 320 (estimated)
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 38 sites (Beijing, Beijing Municipality and 37 other locations)
• Trial ID: NCT07245407 on ClinicalTrials.gov

What this trial studies

Researchers will enroll adults with physician-diagnosed non-cystic fibrosis bronchiectasis and healthy controls at several Beijing hospitals and collect clinical data, lung function, imaging, sputum and blood samples. Collected samples will undergo biomarker assays and multi-omics analyses (for example genomics, transcriptomics, proteomics or microbiome profiling) to link molecular signatures with clinical features. Participants will be followed per protocol timelines for sample collection and clinical stability, and data will be integrated to define molecular endotypes. The aim is to map disease pathways in Chinese patients and compare findings to known clinical phenotypes.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults (≥18 years for bronchiectasis cohort; healthy controls ≥30 years) with physician-documented non-cystic fibrosis bronchiectasis who are clinically stable and able to perform lung function testing and study procedures.

Not a fit: Patients with cystic fibrosis, those currently in an acute exacerbation or unable to complete required testing and follow-up are unlikely to benefit directly from this observational protocol.

Why it matters

Potential benefit: If successful, this work could help tailor future treatments by identifying molecular subtypes that predict different disease courses or therapy responses.

How similar studies have performed: Large registries like BE-China and EMBARC have documented clinical differences across populations, and emerging multi-omics work suggests promise, but comprehensive molecular endotyping specifically in Chinese bronchiectasis patients remains relatively novel.

Eligibility criteria

Inclusion Criteria:

Healthy control cohort:

· Age ≥30 years

Bronchiectasis cohort:

* Capable of giving signed informed consent.
* Participant must be ≥18 years of age, at the time of signing the ICF.
* Able to perform acceptable lung function testing according to ATS/ERS 2019 acceptability criteria.
* Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center, and use electronic devices (e.g. FENO and spirometry).
* Documented physician-diagnosed bronchiectasis: with a clinical history consistent with bronchiectasis (chronic cough and daily sputum production etc.) and having performed chest HRCT indicating bronchiectasis.
* Remaining clinically stable upon recruitment. Patients with exacerbations are allowed to be enrolled into the study at least 4 weeks after the end of exacerbations. If a patient experiencing exacerbation and directly enters the exacerbation visit, the patient is required to come to the study site for baseline visit (after confirming that all inclusion/exclusion criteria are met) within 4 weeks /+ 3 days after the end of exacerbation

Exclusion Criteria:

Healthy control cohort:

* Any respiratory diagnosis (asthma, COPD, bronchiectasis, pulmonary fibrosis or any other chronic respiratory condition requiring regular treatment).
* Inflammatory conditions including rheumatoid arthritis, inflammatory bowel disease, any other connective tissue disease.
* Active malignancy excluding non-melanoma skin cancer.
* Antibiotic treatment for an acute respiratory tract infection in the previous 4 weeks or current sinusitis.
* Any contraindication to study procedures including bronchoscopy.
* Current smoking or smoking in the preceding 3 months.
* Treatment with anti-coagulants.

Bronchiectasis cohort:

* Traction bronchiectasis associated with interstitial lung disease or other pulmonary disorders (e.g., pulmonary fibrosis and cystic fibrosis).
* Primary diagnosis of another pulmonary condition, including COPD, asthma. Patients with a secondary diagnosis of these pulmonary diseases will be allowed to participate as long as bronchiectasis is considered by the investigator to be the primary diagnosis.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
* Affect the safety of the participant throughout the study
* Influence the findings of the study or the interpretation
* Impede the participant's ability to complete the entire duration of study
* The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
* Active malignancy excluding non-melanoma skin cancer.
* Participants is female who is pregnant or lactating or up to 6 weeks post-partum or 6 weeks cessation of breastfeeding.
* The participant has an altered mental status at the time of informed consent.
* History or current evidence of an upper or lower respiratory infection or symptoms(including common cold) within 2 weeks of baseline assessments
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study center).
* Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation.

Where this trial is running

Beijing, Beijing Municipality and 37 other locations

• Beijing Chaoyang Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Active_not_recruiting)
• Beijing Hospital — Beijing, Beijing Municipality, China (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 (Recruiting)
• The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China (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 (Recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Zhengzhou People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Shiyan Taihe Hospital — Shiya, Hubei, China (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 (Recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Active_not_recruiting)
• Weifang People's Hospital — Weifang, Shandong, China (Recruiting)
• Huadong Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Shanghai Fifth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Shanghai Tongji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhongshan Hospital Affiliated to FuDan University" — Shanghai, Shanghai Municipality, China (Active_not_recruiting)
• Chengdu Fifth People's Hospital — Chengdu, Sichuan, China (Recruiting)
• Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Anning First People's Hospital — Anning, Yunnan, China (Active_not_recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Active_not_recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Active_not_recruiting)
• Jiaxing Second Hospital — Jiaxing, Zhejiang, China (Active_not_recruiting)
• Ningbo Fenghua District People's Hospital — Ningbo, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Active_not_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
• Huzhou Central Hospital — Huzhou, Zhejing, China (Active_not_recruiting)
• Jiaxing First Hospital — Jiaxing, Zhejing, China (Active_not_recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: Jinfu Xu, Doctor — Shanghai Tongji Hospital, Tongji University School of Medicine
• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Non-cystic Fibrosis Bronchiectasis; NCFBE