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Clinical Trial NCT07245407 for Non-cystic Fibrosis Bronchiectasis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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AstraZenecaA Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE 320 Biomarker-Driven Translation Available
Clinical Trial NCT07245407 is an observational study for Non-cystic Fibrosis Bronchiectasis that is recruiting. It started on 27 October 2025 with plans to enroll 320 participants. Led by AstraZeneca, it is expected to complete by 29 July 2027. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
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 pre...Show More
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. W...
Show MoreOfficial Title
A Multi-center Longitudinal Observation Translational Study to Evaluate Phenotypes, Endotypes and Biomarkers in Chinese Patients With NCFBE
Conditions
Non-cystic Fibrosis BronchiectasisOther Study IDs
- D9186R00001
NCT ID Number
Start Date (Actual)
2025-10-27
Last Update Posted
2026-03-30
Completion Date (Estimated)
2027-07-29
Enrollment (Estimated)
320
Study Type
Observational
Status
Recruiting
Keywords
NCFBE
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | Participant Follow-up 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 w...Show More |
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. | Participant Follow-up 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 w...Show More |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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.
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.
AstraZeneca772 active studies to exploreStudy Central Contact
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
38 Study Locations in 1 Countries
Beijing Municipality
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
Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Recruiting
Fujian
The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, China
Recruiting
Gansu
Gansu Provincial Hospital, Lanzhou, Gansu, China
Active, not recruiting
Guangdong
Shenzhen People's Hospital, Shenzhen, Guangdong, China
Active, not recruiting
Affiliated Hospital of Guangdong Medical University", Zhanjiang, Guangdong, China
Recruiting
Guangxi
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Recruiting
Guizhou
Guizhou Provincial People's Hospital, Guiyang, Guizhou, China
Recruiting
Henan
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Recruiting
Zhengzhou People's Hospital, Zhengzhou, Henan, China
Recruiting
Hubei
Shiyan Taihe Hospital, Shiya, Hubei, China
Recruiting
Hunan
Xiangya Hospital of Central South University, Changsha, Hunan, China
Active, not recruiting
Jiangsu
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
Active, not recruiting
Jiangxi
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Recruiting
Jilin
The Second Hospital of Jilin University, Changchun, Jilin, China
Active, not recruiting
Shandong
Weifang People's Hospital, Weifang, Shandong, China
Recruiting
Shanghai Municipality
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
Sichuan
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
Yunnan
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
Zhejiang
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
Zhejing
Huzhou Central Hospital, Huzhou, Zhejing, China
Active, not recruiting
Jiaxing First Hospital, Jiaxing, Zhejing, China
Active, not recruiting
Zhengzhou
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Zhengzhou, China
Recruiting