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
This trial accepts healthy volunteersQualifiers
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 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Participant Follow-up
Other interventionThis 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.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: Healthy control cohort1 intervention
Group B: Bronchiectasis cohort1 intervention
Trial outcomes
Primary outcomes
1
FEV1/FVC%
Evaluation of lung function
Time frame
12 month2
FEF25-75 L/s
Evaluation of small airway function
Time frame
12 month3
FENO ppb
Evaluation of airway inflammation: FENO.
Time frame
12 month4
HRCT
Evaluation of lung structure profile and change through radiological parameters.
Time frame
12 monthSponsors and contacts
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Source ClinicalTrials.gov