Brief Summary

Non-cystic ﬁbrosis bronchiectasis (NCFBE) is a chronic respiratory disease characterized by a clinical syndrome of chronic productive cough and recurrent respiratory infections in the presence of abnormal and permanent dilation of the bronchi. Recent epidemiological studies have clearly shown that the prevalence and incidence of NCFBE are quickly rising both in high- and low-income countries. With the increase of prevalence, bronchiectasis brings huge medical and economic burden to the society. In this study, the investigator will perform biomarker assessments and multi-omics analysis on NCFBE patients and healthy participants in China to validate the link of disease pathways to pathophysiological features and uncover the molecular endotypes behind clinical phenotypesof Chinese patients with NCFBE.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

320

participants targeted

Target at P75+ for all trials

Timeline

15mo left

Started Oct 2025

Geographic Reach

1 country

38 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Progress30%

Oct 2025Jul 2027

First Submitted

Initial submission to the registry

September 29, 2025

Completed

28 days until next milestone

Study Start

First participant enrolled

October 27, 2025

Completed

28 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

September 29, 2025

Last Update Submit

April 24, 2026

Conditions

Non-cystic Fibrosis Bronchiectasis

Keywords

NCFBE

Outcome Measures

Primary Outcomes (24)

FEV1/FVC%
Evaluation of lung function
12 month
FEF25-75 L/s
Evaluation of small airway function
12 month
FENO ppb
Evaluation of airway inflammation: FENO.
12 month
HRCT
Evaluation of lung structure profile and change through radiological parameters.
12 month
cell percentage (%)
Measurement of immune cell (including but not limited to neutrophils and eosinophils) percentages in blood
12 month
Gene expression read counts by RNAseq
Functional and transcriptional characterization of airway immune cells, bronchial epithelial cells andsmooth muscle cells (optional).
12 month
Molecular deliverables
MUC5AC/5B in sputum
12 month
on-set age(years-old)
Risk factor assessment: on-set age(years-old)
12 month
Sex(M/F)
Risk factor assessment: Sex(M/F)
12 month
body mass index(kg/m^2)
Risk factor assessment: body mass index(kg/m\^2)
12 month
comorbidities
Risk factor assessment: comorbidities
12 month
medical history
Risk factor assessment: medical history, especially TB history
12 month
smoking status(never/current/former)
Risk factor assessment: smoking status(never/current/former)
12 month
smoking pack years(pack/year)
Risk factor assessment: smoking pack years(pack/year)
12 month
Sputum microbiology (CFU)
Bronchiectasis aetiology evaluation
12 month
Historical Exacerbation
Risk factor assessment: exacerbation number in the previous year
12 month
BSI score
Evaluation of ronchiectasis disease severity: BSI score(0-4 mild,5-8 moderate, ≥9 severe)
12 month
QoL-B-RSS
Evaluation of quality of life: Patient reported outcome: QoL-B-RSS (0-100, higher score stands for lower symptom burden and higher quality of life)
12 month
BHQ
Evaluation of quality of life: Patient reported outcome: BHQ(10-70,higher score stands for higher symptom burden and pooer quality of life )
12 month
BEST
eDiary: BEST(MCID 4 points may standfor an exacerbation.)
12 month
Treatment pattern
Evaluation of treatment pattern: inhaled antibiotic, macrolide, and mucoactive drugs,etc.
12 month
Exacerbation assessment
Exacerbation assessment: number of exacerbations per patient per year
12 month
Cell counts (10^9/L)
Measurement of immune cell (including but not limited to neutrophils and eosinophils) counts in blood
12 month
Exacerbation assessment about hospitalization
Exacerbation assessment: number of exacerbations lead to hospitalization per patient per year
12 month

Study Arms (2)

Healthy control cohort

Healthy controls will include at least 20 healthy participants aged 30 years or older, with no clinically significant lung disease or chronic lung disease.

Other: Participant Follow-up

Bronchiectasis cohort

A total of up to 300 NCFBE patients (males and females aged 18 years or older) will be recruited and enrolled into the study. Patient numbers are mainly based on feasible situation. Approximately 30% of NCFBE patients in the study will be required to have had at least 2 exacerbations in the past 12 months.

Other: Participant Follow-up

Interventions

Participant Follow-upOTHER

This is a longitudinal multi-center, observational, translational study which includes patients with a physician diagnosis of NCFBE by chest HRCT and healthy controls (at baseline only). This study will consist of a baseline visit, a 6-month (site visit or telephone visit) and a 12-month visit as well as planned unscheduled visits for exacerbation events and one optional visit for bronchoscopy.Healthy participants will be only enrolled in the baseline visit and bronchoscopy visit.

Bronchiectasis cohortHealthy control cohort

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Healthy controls will include at least 20 healthy participants aged 30 years or older, with no clinically significant lung disease or chronic lung disease. A total of up to 300 NCFBE patients (males and females aged 18 years or older) will be recruited and enrolled into the study. Patient numbers are mainly based on feasible situation. Approximately 30% of NCFBE patients in the study will be required to have had at least 2 exacerbations in the past 12 months. A subset of 60 NCFBE patients and 20 healthy participants is planned for an optional bronchoscopy assessment.

You may qualify if:

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.

You may not qualify if:

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
+7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

AstraZenecalead

Study Sites (38)

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