Non-cystic Fibrosis BronchiectasisNCT07245407
A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE
An observational study of Non-cystic Fibrosis Bronchiectasis, run by AstraZeneca at 38 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- Participant Follow-up
- How many people
- 251 participants
- Where
- 38 sitesChina
- Study dates
- 27 Oct 2025to 29 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
China38 sites
Anning First People's Hospital
Anning, Yunnan
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Beijing Hospital
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
The Second Hospital of Jilin University
Changchun, Jilin
Xiangya Hospital of Central South University
Changsha, Hunan
Chengdu Fifth People's Hospital
Chengdu, Sichuan
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Guizhou Provincial People's Hospital
Guiyang, Guizhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Huzhou Central Hospital
Huzhou, Zhejing
Jiaxing Second Hospital
Jiaxing, Zhejiang
Jiaxing First Hospital
Jiaxing, Zhejing
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Gansu Provincial Hospital
Lanzhou, Gansu
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Ningbo Fenghua District People's Hospital
Ningbo, Zhejiang
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian
Huadong Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Shanghai Fifth People's Hospital
Shanghai, Shanghai Municipality
Shanghai General Hospital
Shanghai, Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality
Zhongshan Hospital Affiliated to FuDan University"
Shanghai, Shanghai Municipality
Shenzhen People's Hospital
Shenzhen, Guangdong
Shiyan Taihe Hospital
Shiya, Hubei
Weifang People's Hospital
Weifang, Shandong
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Zhengzhou
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Affiliated Hospital of Guangdong Medical University"
Zhanjiang, Guangdong
Henan Provincial People's Hospital
Zhengzhou, Henan
Zhengzhou People's Hospital
Zhengzhou, Henan
About this study
Official title: A Multi-center Longitudinal Observation Translational Study to Evaluate Phenotypes, Endotypes and Biomarkers in Chinese Patients With NCFBE
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.
Read the detailed description
Background/Rationale:
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.
Recently published Chinese Bronchiectasis Registry study (BE-China) data showed that Chinese bronchiectasis patients exhibit unique clinical characteristics when compared to western countries. The proportion of post-infective causes and tuberculosis in China was twice that of the European Multicenter Bronchiectasis Audit and Research Collaboration (EMBARC) cohort. Moreover, Chinese patients had a lower FEV1% of predicted value, and a higher proportion of obstruction compared to the EMBARC cohort. Pseudomonas aeruginosa (PsA) was the most common pathogen in both cohorts.
Chinese patients exhibited a higher frequency of hospitalization compared to the EMBARC cohort (57.2% vs 26.4%); however, unlike the frequency of hospitalization, Chinese patients had fewer exacerbations in the year before enrollment compared to the EMBARC cohort, with most having only one exacerbation. The proportion of patients with three or more exacerbations was much higher in the EMBARC cohort than in China (12.3% vs 38.8%). Except for Aspergillus fumigatus, the positive culture rates of other pathogens were much higher in the EMBARC cohort than in China.
Significant difference in aetiology and clinical phenotypes of NCFBE has been demonstrated by many registry studies conducted in different geographical regions including EMBARC and BE-China. However, the biological processes and mechanisms driving the disease development, so-called "endotypes", have not been fully investigated within the patient populations in these studies. It is remaining unknown that if these differences reported in clinical phenotypes were truly caused by or linked to different endotypes in NCFBE.
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.
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- Participant Follow-up
- Keywords
- NCFBE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Participant Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC%
Evaluation of lung function
Measured: 12 month
FEF25-75 L/s
Evaluation of small airway function
Measured: 12 month
FENO ppb
Evaluation of airway inflammation: FENO.
Measured: 12 month
HRCT
Evaluation of lung structure profile and change through radiological parameters.
Measured: 12 month
cell percentage (%)
Measurement of immune cell (including but not limited to neutrophils and eosinophils) percentages in blood
Measured: 12 month
Gene expression read counts by RNAseq
Functional and transcriptional characterization of airway immune cells, bronchial epithelial cells andsmooth muscle cells (optional).
Measured: 12 month
Molecular deliverables
MUC5AC/5B in sputum
Measured: 12 month
on-set age(years-old)
Risk factor assessment: on-set age(years-old)
Measured: 12 month
Sex(M/F)
Risk factor assessment: Sex(M/F)
Measured: 12 month
body mass index(kg/m^2)
Risk factor assessment: body mass index(kg/m^2)
Measured: 12 month
comorbidities
Risk factor assessment: comorbidities
Measured: 12 month
medical history
Risk factor assessment: medical history, especially TB history
Measured: 12 month
smoking status(never/current/former)
Risk factor assessment: smoking status(never/current/former)
Measured: 12 month
smoking pack years(pack/year)
Risk factor assessment: smoking pack years(pack/year)
Measured: 12 month
Sputum microbiology (CFU)
Bronchiectasis aetiology evaluation
Measured: 12 month
Historical Exacerbation
Risk factor assessment: exacerbation number in the previous year
Measured: 12 month
BSI score
Evaluation of ronchiectasis disease severity: BSI score(0-4 mild,5-8 moderate, ≥9 severe)
Measured: 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)
Measured: 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 )
Measured: 12 month
BEST
eDiary: BEST(MCID 4 points may standfor an exacerbation.)
Measured: 12 month
Treatment pattern
Evaluation of treatment pattern: inhaled antibiotic, macrolide, and mucoactive drugs,etc.
Measured: 12 month
Exacerbation assessment
Exacerbation assessment: number of exacerbations per patient per year
Measured: 12 month
Cell counts (10^9/L)
Measurement of immune cell (including but not limited to neutrophils and eosinophils) counts in blood
Measured: 12 month
Exacerbation assessment about hospitalization
Exacerbation assessment: number of exacerbations lead to hospitalization per patient per year
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start27 Oct 2025
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinfu Xu, Doctor, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245407
- Sponsor's protocol ID
- D9186R00001
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Longitudinal Observation Translational Study to Evaluate Phenotypes, Endotypes and Biomarkers in Chinese Patients With NCFBE
- ClinicalTrials.gov ID
- NCT07245407
- Acronym / sponsor ID
- D9186R00001
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Keywords
- NCFBE
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 251 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 29 Jul 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Rationale:
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.
Recently published Chinese Bronchiectasis Registry study (BE-China) data showed that Chinese bronchiectasis patients exhibit unique clinical characteristics when compared to western countries. The proportion of post-infective causes and tuberculosis in China was twice that of the European Multicenter Bronchiectasis Audit and Research Collaboration (EMBARC) cohort. Moreover, Chinese patients had a lower FEV1% of predicted value, and a higher proportion of obstruction compared to the EMBARC cohort. Pseudomonas aeruginosa (PsA) was the most common pathogen in both cohorts.
Chinese patients exhibited a higher frequency of hospitalization compared to the EMBARC cohort (57.2% vs 26.4%); however, unlike the frequency of hospitalization, Chinese patients had fewer exacerbations in the year before enrollment compared to the EMBARC cohort, with most having only one exacerbation. The proportion of patients with three or more exacerbations was much higher in the EMBARC cohort than in China (12.3% vs 38.8%). Except for Aspergillus fumigatus, the positive culture rates of other pathogens were much higher in the EMBARC cohort than in China.
Significant difference in aetiology and clinical phenotypes of NCFBE has been demonstrated by many registry studies conducted in different geographical regions including EMBARC and BE-China. However, the biological processes and mechanisms driving the disease development, so-called "endotypes", have not been fully investigated within the patient populations in these studies. It is remaining unknown that if these differences reported in clinical phenotypes were truly caused by or linked to different endotypes in NCFBE.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control cohort | – | Other: Participant Follow-upHealthy controls will include at least 20 healthy participants aged 30 years or older, with no clinically significant lung disease or chronic lung disease. |
| Bronchiectasis cohort | – | Other: Participant Follow-upA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Age ≥30 years
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant Follow-upThis 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. | Other | Bronchiectasis cohort, Healthy control cohort |
Primary outcome
FEV1/FVC%
Time frame: 12 month
Evaluation of lung function
FEF25-75 L/s
Time frame: 12 month
Evaluation of small airway function
FENO ppb
Time frame: 12 month
Evaluation of airway inflammation: FENO.
HRCT
Time frame: 12 month
Evaluation of lung structure profile and change through radiological parameters.
cell percentage (%)
Time frame: 12 month
Measurement of immune cell (including but not limited to neutrophils and eosinophils) percentages in blood
Gene expression read counts by RNAseq
Time frame: 12 month
Functional and transcriptional characterization of airway immune cells, bronchial epithelial cells andsmooth muscle cells (optional).
Molecular deliverables
Time frame: 12 month
MUC5AC/5B in sputum
on-set age(years-old)
Time frame: 12 month
Risk factor assessment: on-set age(years-old)
Sex(M/F)
Time frame: 12 month
Risk factor assessment: Sex(M/F)
body mass index(kg/m^2)
Time frame: 12 month
Risk factor assessment: body mass index(kg/m^2)
comorbidities
Time frame: 12 month
Risk factor assessment: comorbidities
medical history
Time frame: 12 month
Risk factor assessment: medical history, especially TB history
smoking status(never/current/former)
Time frame: 12 month
Risk factor assessment: smoking status(never/current/former)
smoking pack years(pack/year)
Time frame: 12 month
Risk factor assessment: smoking pack years(pack/year)
Sputum microbiology (CFU)
Time frame: 12 month
Bronchiectasis aetiology evaluation
Historical Exacerbation
Time frame: 12 month
Risk factor assessment: exacerbation number in the previous year
BSI score
Time frame: 12 month
Evaluation of ronchiectasis disease severity: BSI score(0-4 mild,5-8 moderate, ≥9 severe)
QoL-B-RSS
Time frame: 12 month
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)
BHQ
Time frame: 12 month
Evaluation of quality of life: Patient reported outcome: BHQ(10-70,higher score stands for higher symptom burden and pooer quality of life )
BEST
Time frame: 12 month
eDiary: BEST(MCID 4 points may standfor an exacerbation.)
Treatment pattern
Time frame: 12 month
Evaluation of treatment pattern: inhaled antibiotic, macrolide, and mucoactive drugs,etc.
Exacerbation assessment
Time frame: 12 month
Exacerbation assessment: number of exacerbations per patient per year
Cell counts (10^9/L)
Time frame: 12 month
Measurement of immune cell (including but not limited to neutrophils and eosinophils) counts in blood
Exacerbation assessment about hospitalization
Time frame: 12 month
Exacerbation assessment: number of exacerbations lead to hospitalization per patient per year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingPhase 1
Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinfu Xu, Doctor principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-cystic Fibrosis Bronchiectasis, run by AstraZeneca at 38 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1/FVC% (time frame: 12 month). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.