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NCT Number: NCT07245407

A Translational Study for Phenotyping and Endotyping Chinese Patients With NCFBE

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.

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Key information

Conditions

Non-cystic Fibrosis Bronchiectasis

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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. With the increase of prevalence, bronchiectasis brings huge medical and economic burden to the society.

Recently published Chinese Bronchiectasis Registry study (BE-China) data showed that Chinese bronchiectasis patients exhibit unique clinical characteristics when compared to western countries. The proportion of post-infective causes and tuberculosis in China was twice that of the European Multicenter Bronchiectasis Audit and Research Collaboration (EMBARC) cohort. Moreover, Chinese patients had a lower FEV1% of predicted value, and a higher proportion of obstruction compared to the EMBARC cohort. Pseudomonas aeruginosa (PsA) was the most common pathogen in both cohorts.

Chinese patients exhibited a higher frequency of hospitalization compared to the EMBARC cohort (57.2% vs 26.4%); however, unlike the frequency of hospitalization, Chinese patients had fewer exacerbations in the year before enrollment compared to the EMBARC cohort, with most having only one exacerbation. The proportion of patients with three or more exacerbations was much higher in the EMBARC cohort than in China (12.3% vs 38.8%). Except for Aspergillus fumigatus, the positive culture rates of other pathogens were much higher in the EMBARC cohort than in China.

Significant difference in aetiology and clinical phenotypes of NCFBE has been demonstrated by many registry studies conducted in different geographical regions including EMBARC and BE-China. However, the biological processes and mechanisms driving the disease development, so-called "endotypes", have not been fully investigated within the patient populations in these studies. It is remaining unknown that if these differences reported in clinical phenotypes were truly caused by or linked to different endotypes in NCFBE.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Participant Follow-up

Other

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 will be only enrolled in the baseline visit and bronchoscopy visit.

Primary outcomes

  1. FEV1/FVC%

    Time frame: 12 month

    Evaluation of lung function

  2. FEF25-75 L/s

    Time frame: 12 month

    Evaluation of small airway function

  3. FENO ppb

    Time frame: 12 month

    Evaluation of airway inflammation: FENO.

  4. HRCT

    Time frame: 12 month

    Evaluation of lung structure profile and change through radiological parameters.

  5. cell percentage (%)

    Time frame: 12 month

    Measurement of immune cell (including but not limited to neutrophils and eosinophils) percentages in blood

  6. Gene expression read counts by RNAseq

    Time frame: 12 month

    Functional and transcriptional characterization of airway immune cells, bronchial epithelial cells andsmooth muscle cells (optional).

  7. Molecular deliverables

    Time frame: 12 month

    MUC5AC/5B in sputum

  8. on-set age(years-old)

    Time frame: 12 month

    Risk factor assessment: on-set age(years-old)

  9. Sex(M/F)

    Time frame: 12 month

    Risk factor assessment: Sex(M/F)

  10. body mass index(kg/m^2)

    Time frame: 12 month

    Risk factor assessment: body mass index(kg/m^2)

  11. comorbidities

    Time frame: 12 month

    Risk factor assessment: comorbidities

  12. medical history

    Time frame: 12 month

    Risk factor assessment: medical history, especially TB history

  13. smoking status(never/current/former)

    Time frame: 12 month

    Risk factor assessment: smoking status(never/current/former)

  14. smoking pack years(pack/year)

    Time frame: 12 month

    Risk factor assessment: smoking pack years(pack/year)

  15. Sputum microbiology (CFU)

    Time frame: 12 month

    Bronchiectasis aetiology evaluation

  16. Historical Exacerbation

    Time frame: 12 month

    Risk factor assessment: exacerbation number in the previous year

  17. BSI score

    Time frame: 12 month

    Evaluation of ronchiectasis disease severity: BSI score(0-4 mild,5-8 moderate, ≥9 severe)

  18. QoL-B-RSS

    Time frame: 12 month

    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)

  19. BHQ

    Time frame: 12 month

    Evaluation of quality of life: Patient reported outcome: BHQ(10-70,higher score stands for higher symptom burden and pooer quality of life )

  20. BEST

    Time frame: 12 month

    eDiary: BEST(MCID 4 points may standfor an exacerbation.)

  21. Treatment pattern

    Time frame: 12 month

    Evaluation of treatment pattern: inhaled antibiotic, macrolide, and mucoactive drugs,etc.

  22. Exacerbation assessment

    Time frame: 12 month

    Exacerbation assessment: number of exacerbations per patient per year

  23. Cell counts (10^9/L)

    Time frame: 12 month

    Measurement of immune cell (including but not limited to neutrophils and eosinophils) counts in blood

  24. Exacerbation assessment about hospitalization

    Time frame: 12 month

    Exacerbation assessment: number of exacerbations lead to hospitalization per patient per year

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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