Bronchiectasis Clinical Trials

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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
China
Anning First People's Hospital
ACTIVE_NOT_RECRUITING
Anning
Beijing Chaoyang Hospital Affiliated to Capital Medical University
ACTIVE_NOT_RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
Peking University People's Hospital
ACTIVE_NOT_RECRUITING
Beijing
The Second Hospital of Jilin University
ACTIVE_NOT_RECRUITING
Changchun
Xiangya Hospital of Central South University
ACTIVE_NOT_RECRUITING
Changsha
Chengdu Fifth People's Hospital
RECRUITING
Chengdu
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
The Second Affiliated Hospital of Zhejiang University School of Medicine
ACTIVE_NOT_RECRUITING
Hangzhou
Huzhou Central Hospital
ACTIVE_NOT_RECRUITING
Huzhou
Jiaxing First Hospital
ACTIVE_NOT_RECRUITING
Jiaxing
Jiaxing Second Hospital
ACTIVE_NOT_RECRUITING
Jiaxing
The First Affiliated Hospital of Kunming Medical University
ACTIVE_NOT_RECRUITING
Kunming
Gansu Provincial Hospital
ACTIVE_NOT_RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Ningbo Fenghua District People's Hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Ningbo University
ACTIVE_NOT_RECRUITING
Ningbo
The Second Affiliated Hospital of Fujian Medical University
RECRUITING
Quanzhou
Huadong Hospital Affiliated to Fudan University
RECRUITING
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Fifth People's Hospital
RECRUITING
Shanghai
Shanghai General Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Pulmonary Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Tongji Hospital
RECRUITING
Shanghai
Zhongshan Hospital Affiliated to FuDan University
ACTIVE_NOT_RECRUITING
Shanghai
Shenzhen People's Hospital
ACTIVE_NOT_RECRUITING
Shenzhen
Shiyan Taihe Hospital
RECRUITING
Shiya
Weifang People's Hospital
RECRUITING
Weifang
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
ACTIVE_NOT_RECRUITING
Xuzhou
Affiliated Hospital of Guangdong Medical University
RECRUITING
Zhanjiang
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Zhengzhou People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2027-07-29
Participants
Target number of participants: 320
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov