A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE
ConditionNon-cystic Fibrosis Bronchiectasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Participant Follow-up
Treatment groups
320 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov