NCT07245407 A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 320 participants in total. It began in 2025-10-27 with a primary completion date of 2027-07-29.

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.

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.

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