Bronchiectasis AdultNCT06900062
The C-BRIDGE Study: China Bronchiectasis Research Involving Databases, Genomics, and Endotyping
An observational study of Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 9 sites in China.
Trial summary
Bronchiectasis is a heterogeneous airway disease with diverse causes, making precise diagnosis, prognosis, and treatment response prediction challenging. Identifying patient subgroups (phenotypes) and molecular profiles (endotypes) can enhance individualized assessment and management. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 1,500 participants
- Where
- 9 sitesChina
- Study dates
- 6 Apr 2025to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Adult patients with bronchiectasis
Who may be able to join
- A prior CT scan confirming bronchiectasis, accompanied by a compatible clinical syndrome including cough, sputum production, and/or recurrent respiratory tract infections.
- At the screening visit, participants must have been clinically stable for 4 weeks, defined as no antibiotic or corticosteroid treatment for a pulmonary exacerbation in the preceding 4 weeks.
Who cannot join
- Inability to provide informed consent
- Age under 18 years
- Patients with active tuberculosis
- Use of antibiotics or corticosteroids for a pulmonary exacerbation within the past 4 weeks
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Lei Song
Changchun, Jilin
Lei Song, PhD, +8615948025862, lsong@jlu.edu.cn
- Recruiting
Lin Liu
Guiyang, Guizhou
Lin Liu, MD, +8618685109665, liulin0956@163.com
- Recruiting
Xiao-long Ma
Jiaxing, Zhejiang
Xiao-long Ma, MD, +8618805839188, maxiaolong801005@sina.com
- Recruiting
Qian Qi
Jinan, Shangdong
Qian Qi, MD, +8613706380314, qiqianqlh@163.com
- Recruiting
He-feng Chen
Shanghai, Shanghai Municipality, 200433
He-feng Chen, MD, +8613917472201, 13917472201@163.com
- Recruiting
Zhou-fang Mei
Shanghai, Shanghai Municipality, 200433
Zhou-fang Mei, MD, 13817546940, meizhoufang8@163.com
- Recruiting
Jun She
Shanghai, Shanghai Municipality, 200437
Jun She, PhD, +8613641093865, she.jun@zs-hospital.sh.cn
- Recruiting
Xue-ling Wu
Shanghai, Shanghai Municipality, 200437
Xue-ling Wu, MD, +8618321035326
- Recruiting
Yong-hua Gao
Shanghai, Shanghai Municipality, 200437
Yong-hua Gao, PhD, +8617321278520, gaoyonghuahust@163.com
About this study
Bronchiectasis is a heterogeneous airway disease with diverse causes, making precise diagnosis, prognosis, and treatment response prediction challenging. Identifying patient subgroups (phenotypes) and molecular profiles (endotypes) can enhance individualized assessment and management. While prior studies, primarily in European populations, have identified key phenotypes and endotypes, their relevance to Chinese patients remains unclear due to geographic and clinical differences. Specific causes of bronchiectasis, such as allergic bronchopulmonary aspergillosis (ABPA) and primary ciliary dyskinesia (PCD), may also exhibit distinct pathophysiology requiring further exploration. The C-BRIDGE Study seeks to characterize phenotypes and endotypes in Chinese bronchiectasis patients during stable disease and exacerbations, evaluate differences in clinical outcomes across these subgroups, and develop personalized medicine strategies based on these findings, applicable in China and globally.
Primary Objective: To identify molecular endotypes of bronchiectasis that accurately predict prognosis and guide treatment responses.
Read more
Secondary Objectives:
To characterize molecular endotypes of stable bronchiectasis in Chinese patients.
To define molecular endotypes of bronchiectasis exacerbations in Chinese patients.
To investigate molecular endotypes specific to allergic bronchopulmonary aspergillosis (ABPA).
To explore genotypes and inflammatory endotypes of cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) in Chinese patients.
To validate candidate biomarkers for stable and exacerbation endotypes to support stratified medicine.
To conduct in vivo or in vitro proof-of-concept studies using phenotypic data to identify patient subgroups likely to benefit from specific pharmacological interventions.
Study Design: This observational cohort study will link identified patient subgroups with meaningful clinical outcomes to inform prognosis and optimize treatment strategies.
Read the detailed description
Bronchiectasis is a common, heterogeneous chronic airway disease that remains understudied in clinical and translational research. Although several phenotypes and endotypes have been identified-primarily in European populations-data from Chinese patients are limited. Racial and geographic differences suggest that bronchiectasis phenotypes and endotypes in China may differ from those in Western cohorts. Recent controlled trials have failed to meet primary endpoints, likely due to insufficient identification of patient subgroups that optimally respond to antibiotics, mucoactive agents, or anti-inflammatory therapies. The C-BRIDGE Study seeks to address this gap by exploring the clinical, genomic, microbiological, inflammatory, and functional heterogeneity of bronchiectasis in Chinese patients to define molecular endotypes for stratified assessment and management.
Study Aims and Objectives:
- Characterize molecular endotypes of stable bronchiectasis in Chinese patients.
- Identify molecular endotypes of bronchiectasis exacerbations in Chinese patients.
- Investigate molecular endotypes in patients with allergic bronchopulmonary aspergillosis (ABPA).
- Develop a screening algorithm and elucidate genotypes and inflammatory endotypes of cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) in China.
- Validate candidate biomarkers for stable and exacerbation endotypes to enable stratified medicine.
- Perform in vivo and in vitro proof-of-concept studies using phenotypic data to pinpoint patient subgroups likely to benefit from specific pharmacological treatments.
Study Design:
Observational cohort study.
Study Methods:
A target of 1,500 patients with bronchiectasis will be recruited across participating centers for an observational study with the following aims:
Aim 1: Stable Disease Endotyping Up to 1,500 patients will be studied to define and validate endotypes of stable bronchiectasis. Data collection will include clinical assessments, sputum and nasal microbiome analysis, sputum proteomics, nasal and airway transcriptomics, single-cell sequencing of bronchoalveolar lavage fluid (BALF), and measurement of inflammatory markers in systemic, nasal, sputum, and BALF samples. A sub-study (n=100) will use air-liquid interface cultures of primary airway epithelial cells to assess responses to various stimuli and pharmacological interventions.
Aim 2: Exacerbation Endotyping A subset of 200 patients will be evaluated during exacerbations to replicate the phenotyping approach. This will involve analyzing changes from baseline in microbiome, proteomics, metabolomics, and other markers to identify clusters linked to exacerbation onset, progression, and outcomes.
Aim 3: Allergic Bronchopulmonary Aspergillosis (ABPA) Subgroup Analysis A subset of 150 patients with ABPA will be studied to investigate molecular endotypes by integrating single-cell sequencing, microbiome, mycobiome, proteomics, metabolomics, and other markers to identify clusters associated with exacerbation, recurrence, and treatment responses.
Aim 4: Idiopathic Bronchiectasis and Genetic Screening Patients with idiopathic bronchiectasis will be screened for cystic fibrosis, CFTR-related disorders, and primary ciliary dyskinesia (PCD) to identify genotypes and inflammatory endotypes. This will integrate genomics, microbiome, proteomics, and metabolomics to explore associations among phenotypes, genotypes, endotypes, and prognosis.
Aim 5: Biomarker Validation and Prediction Model Development Candidate phenotypes and endotypes will be externally validated using registered, ethically approved biobanks. Validated biomarkers will be correlated with clinically meaningful outcomes, such as treatment responses, to enable their use in stratified medicine. Clinical data and validated biomarkers will be integrated to construct and validate prediction models for exacerbation frequency, time to first exacerbation, and lung function decline.
Participants will visit the Clinical Research Centre at least once for sampling and clinical data collection, with consent obtained to link their samples to the C-BRIDGE database.
Ethics Approval:
Approved by the Ethics Committee of Shanghai Pulmonary Hospital and other participating centers.
Expected Outcomes:
The C-BRIDGE Study will establish detailed molecular endotypes of bronchiectasis in Chinese patients, facilitating precise prognosis prediction and tailored treatment strategies. By identifying and validating patient subgroups and biomarkers, it will provide a foundation for personalized medicine in bronchiectasis management, with potential relevance in China and worldwide.
- Conditions
- Bronchiectasis Adult
- Keywords
- bronchiectasis, phenotype, endotype, multi-omics, precision medicine
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bronchiectasis | Adult patients diagnosed with bronchiectasis who meet the study's inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of bronchiectasis exacerbations
Worsening of respiratory symptoms, as defined by the EMBARC/BRR criteria (Eur Respir J. 2017;49(6):1700051), requiring adjustments to treatment strategies.
Measured: 2 years
Secondary outcomes (10)
Time to the first exacerbation
Worsening of respiratory symptoms, as defined by the EMBARC/BRR criteria (Eur Respir J. 2017;49(6):1700051), requiring adjustments to treatment strategies.
Measured: 2 years
The Quality of Life Bronchiectasis Respiratory Symptom Scales (QOL-B-RSS)
The Quality-of-Life-Bronchiectasis (QoL-B) questionnaire is a disease-specific survey designed for patients with bronchiectasis. The Respiratory Symptoms scale is a component of the QoL-B questionnaire, with a scale range from 0 to 100. Higher scores on this scale signify a better health status. In bronchiectasis, the established minimal clinically important difference (MCID) is 8 points.
Measured: 2 years
The Bronchiectasis Health Questionnaire (BHQ)
The BHQ is a brief, self-administered tool consisting of 10 items that assess health status over the previous 14 days. It uses 7-point Likert scales, with scores ranging from 0 to 100, where higher scores reflect better health-related quality of life (HRQoL). In bronchiectasis, the established minimal clinically important difference (MCID) is 3 points.
Measured: 2 years
The Bronchiectasis Impact Measure (BIM)
The Bronchiectasis Impact Measure (BIM) is a validated patient-reported outcome measure for patients with bronchiectasis. The BIM includes eight domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) and is numbered 0-10. Higher scores on this scale signify a greater impact of these domains on daily life. In bronchiectasis, the minimal clinically important difference (MCID) for each domain as 1.5 points on a 10-point scale.
Measured: 2 years
The St Georges Respiratory Questionnaire (SGRQ)
St.George Respiratory Questionnaire (SGRQ): a validated questionnaire for use in bronchiectasis population. This questionnaire is structured into 3 main components: symptoms, activity and impacts.
Scale range is 0-100, where lower scores correspond to the better health status.
Each questionnaire response has a unique empirically derived "weight".
Each component of the questionnaire is scored separately in three steps:
- The weights for all items with a positive responses are summed. ii. The weights for missed items are deducted from the maximum possible weight for each component. The weights for all missed items are deducted from the maximum possible weight for the Total score. iii. The score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage The Total score is calculated in similar way. In bronchiectasis, the established MCID is 4 points.
Measured: 2 years
The bronchiectasis exacerbation and symptom tool (BEST)
The Bronchiectasis Exacerbation and Symptom Tool (BEST) is a validated questionnaire designed to evaluate daily symptoms in patients with bronchiectasis. It has a maximum score of 26, with higher scores reflecting a greater symptom burden. In bronchiectasis, the minimal clinically important difference (MCID) is 4 points.
Measured: 2 years
Bronchiectasis Symptom VAS (BS-VAS)
The Bronchiectasis Symptom Visual Analogue Scale (BS-VAS) is a simple, patient-reported tool designed to quantify the severity of individual symptom burden in patients with bronchiectasis. It consists of 11 separate 100-mm horizontal visual analogue scales, each assessing a different core symptom: cough, sputum volume, sputum colour, sputum viscosity, dyspnoea, fatigue, wheezing, chest tightness, chest pain, exercise tolerance, and haemoptysis.
Patients are instructed to mark a vertical line on each 10-mm scale to indicate symptom severity over the past 24 hours, with the left anchor (0 mm) defined as "No symptom at all" and the right anchor (10 mm) defined as "Worst imaginable". Each item is measured from 0 to 10 mm (scored 0-10 with one decimal place).
Measured: 2 years
Forced expiratory volume in 1 second (FEV1)
Spirometry
Measured: 2 years
Hospitalization for severe exacerbations
Admission to hospital for an exacerbation meeting the EMBARC/BRR exacerbation
Measured: 2 years
All cause mortality
Survival during the study
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start6 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Yong-hua, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Yong-hua Gao, Ph.D., Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900062
- Sponsor's protocol ID
- 2024ZD0529700
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao Y, Richardson H, Dicker AJ, Barton A, Kuzmanova E, Shteinberg M, Perea L, Goeminne PC, Cant E, Hennayake C, Pollock J, Abo Leyah H, Choi H, Polverino E, Blasi F, Welte T, Aliberti S, Long M, Shoemark A, Sibila O, Huang JTJ, Chalmers JD. Endotypes of Exacerbation in Bronchiectasis: An Observational Cohort Study. Am J Respir Crit Care Med. 2024 Jul 1;210(1):77-86. doi: 10.1164/rccm.202310-1729OC.
PubMed 38717347Choi H, Ryu S, Keir HR, Giam YH, Dicker AJ, Perea L, Richardson H, Huang JTJ, Cant E, Blasi F, Pollock J, Shteinberg M, Finch S, Aliberti S, Sibila O, Shoemark A, Chalmers JD. Inflammatory Molecular Endotypes in Bronchiectasis: A European Multicenter Cohort Study. Am J Respir Crit Care Med. 2023 Dec 1;208(11):1166-1176. doi: 10.1164/rccm.202303-0499OC.
PubMed 37769155Shoemark A, Shteinberg M, De Soyza A, Haworth CS, Richardson H, Gao Y, Perea L, Dicker AJ, Goeminne PC, Cant E, Polverino E, Altenburg J, Keir HR, Loebinger MR, Blasi F, Welte T, Sibila O, Aliberti S, Chalmers JD. Characterization of Eosinophilic Bronchiectasis: A European Multicohort Study. Am J Respir Crit Care Med. 2022 Apr 15;205(8):894-902. doi: 10.1164/rccm.202108-1889OC.
PubMed 35050830Chalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.
PubMed 29357265Huang JT, Cant E, Keir HR, Barton AK, Kuzmanova E, Shuttleworth M, Pollock J, Finch S, Polverino E, Bottier M, Dicker AJ, Shoemark A, Chalmers JD. Endotyping Chronic Obstructive Pulmonary Disease, Bronchiectasis, and the "Chronic Obstructive Pulmonary Disease-Bronchiectasis Association". Am J Respir Crit Care Med. 2022 Aug 15;206(4):417-426. doi: 10.1164/rccm.202108-1943OC.
PubMed 35436182Shoemark A, Griffin H, Wheway G, Hogg C, Lucas JS; Genomics England Research Consortium; Camps C, Taylor J, Carroll M, Loebinger MR, Chalmers JD, Morris-Rosendahl D, Mitchison HM, De Soyza A; Genomics England Research Consortium:; Brown D, Ambrose JC, Arumugam P, Bevers R, Bleda M, Boardman-Pretty F, Boustred CR, Brittain H, Caulfield MJ, Chan GC, Fowler T, Giess A, Hamblin A, Henderson S, Hubbard TJP, Jackson R, Jones LJ, Kasperaviciute D, Kayikci M, Kousathanas A, Lahnstein L, Leigh SEA, Leong IUS, Lopez FJ, Maleady-Crowe F, McEntagart M, Minneci F, Moutsianas L, Mueller M, Murugaesu N, Need AC, O'Donovan P, Odhams CA, Patch C, Perez-Gil D, Pereira MB, Pullinger J, Rahim T, Rendon A, Rogers T, Savage K, Sawant K, Scott RH, Siddiq A, Sieghart A, Smith SC, Sosinsky A, Stuckey A, Tanguy M, Taylor Tavares AL, Thomas ERA, Thompson SR, Tucci A, Welland MJ, Williams E, Witkowska K, Wood SM. Genome sequencing reveals underdiagnosis of primary ciliary dyskinesia in bronchiectasis. Eur Respir J. 2022 Nov 17;60(5):2200176. doi: 10.1183/13993003.00176-2022. Print 2022 Nov.
PubMed 35728977Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
PubMed 28596426Aliberti S, Lonni S, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Fardon TC, Rutherford R, Pesci A, Restrepo MI, Sotgiu G, Chalmers JD. Clinical phenotypes in adult patients with bronchiectasis. Eur Respir J. 2016 Apr;47(4):1113-22. doi: 10.1183/13993003.01899-2015. Epub 2016 Feb 4.
PubMed 26846833Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, Dimakou K, Clifton I, van der Eerden M, Rohde G, Murris-Espin M, Masefield S, Gerada E, Shteinberg M, Ringshausen F, Haworth C, Boersma W, Rademacher J, Hill AT, Aksamit T, O'Donnell A, Morgan L, Milenkovic B, Tramma L, Neves J, Menendez R, Paggiaro P, Botnaru V, Skrgat S, Wilson R, Goeminne P, De Soyza A, Welte T, Torres A, Elborn JS, Blasi F. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res. 2016 Jan 20;2(1):00081-2015. doi: 10.1183/23120541.00081-2015. eCollection 2016 Jan.
PubMed 27730179
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The C-BRIDGE Study: China Bronchiectasis Research Involving Databases, Genomics, and Endotyping
- ClinicalTrials.gov ID
- NCT06900062
- Acronym / sponsor ID
- 2024ZD0529700
- Conditions
- Bronchiectasis Adult
- Keywords
- bronchiectasis, phenotype, endotype, multi-omics, precision medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiectasis is a heterogeneous airway disease with diverse causes, making precise diagnosis, prognosis, and treatment response prediction challenging. Identifying patient subgroups (phenotypes) and molecular profiles (endotypes) can enhance individualized assessment and management. While prior studies, primarily in European populations, have identified key phenotypes and endotypes, their relevance to Chinese patients remains unclear due to geographic and clinical differences. Specific causes of bronchiectasis, such as allergic bronchopulmonary aspergillosis (ABPA) and primary ciliary dyskinesia (PCD), may also exhibit distinct pathophysiology requiring further exploration. The C-BRIDGE Study seeks to characterize phenotypes and endotypes in Chinese bronchiectasis patients during stable disease and exacerbations, evaluate differences in clinical outcomes across these subgroups, and develop personalized medicine strategies based on these findings, applicable in China and globally.
Primary Objective: To identify molecular endotypes of bronchiectasis that accurately predict prognosis and guide treatment responses.
Secondary Objectives:
To characterize molecular endotypes of stable bronchiectasis in Chinese patients.
To define molecular endotypes of bronchiectasis exacerbations in Chinese patients.
To investigate molecular endotypes specific to allergic bronchopulmonary aspergillosis (ABPA).
To explore genotypes and inflammatory endotypes of cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) in Chinese patients.
To validate candidate biomarkers for stable and exacerbation endotypes to support stratified medicine.
To conduct in vivo or in vitro proof-of-concept studies using phenotypic data to identify patient subgroups likely to benefit from specific pharmacological interventions.
Study Design: This observational cohort study will link identified patient subgroups with meaningful clinical outcomes to inform prognosis and optimize treatment strategies.
Detailed description
Bronchiectasis is a common, heterogeneous chronic airway disease that remains understudied in clinical and translational research. Although several phenotypes and endotypes have been identified-primarily in European populations-data from Chinese patients are limited. Racial and geographic differences suggest that bronchiectasis phenotypes and endotypes in China may differ from those in Western cohorts. Recent controlled trials have failed to meet primary endpoints, likely due to insufficient identification of patient subgroups that optimally respond to antibiotics, mucoactive agents, or anti-inflammatory therapies. The C-BRIDGE Study seeks to address this gap by exploring the clinical, genomic, microbiological, inflammatory, and functional heterogeneity of bronchiectasis in Chinese patients to define molecular endotypes for stratified assessment and management.
Study Aims and Objectives:
- Characterize molecular endotypes of stable bronchiectasis in Chinese patients.
- Identify molecular endotypes of bronchiectasis exacerbations in Chinese patients.
- Investigate molecular endotypes in patients with allergic bronchopulmonary aspergillosis (ABPA).
- Develop a screening algorithm and elucidate genotypes and inflammatory endotypes of cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) in China.
- Validate candidate biomarkers for stable and exacerbation endotypes to enable stratified medicine.
- Perform in vivo and in vitro proof-of-concept studies using phenotypic data to pinpoint patient subgroups likely to benefit from specific pharmacological treatments.
Study Design:
Observational cohort study.
Study Methods:
A target of 1,500 patients with bronchiectasis will be recruited across participating centers for an observational study with the following aims:
Aim 1: Stable Disease Endotyping Up to 1,500 patients will be studied to define and validate endotypes of stable bronchiectasis. Data collection will include clinical assessments, sputum and nasal microbiome analysis, sputum proteomics, nasal and airway transcriptomics, single-cell sequencing of bronchoalveolar lavage fluid (BALF), and measurement of inflammatory markers in systemic, nasal, sputum, and BALF samples. A sub-study (n=100) will use air-liquid interface cultures of primary airway epithelial cells to assess responses to various stimuli and pharmacological interventions.
Aim 2: Exacerbation Endotyping A subset of 200 patients will be evaluated during exacerbations to replicate the phenotyping approach. This will involve analyzing changes from baseline in microbiome, proteomics, metabolomics, and other markers to identify clusters linked to exacerbation onset, progression, and outcomes.
Aim 3: Allergic Bronchopulmonary Aspergillosis (ABPA) Subgroup Analysis A subset of 150 patients with ABPA will be studied to investigate molecular endotypes by integrating single-cell sequencing, microbiome, mycobiome, proteomics, metabolomics, and other markers to identify clusters associated with exacerbation, recurrence, and treatment responses.
Aim 4: Idiopathic Bronchiectasis and Genetic Screening Patients with idiopathic bronchiectasis will be screened for cystic fibrosis, CFTR-related disorders, and primary ciliary dyskinesia (PCD) to identify genotypes and inflammatory endotypes. This will integrate genomics, microbiome, proteomics, and metabolomics to explore associations among phenotypes, genotypes, endotypes, and prognosis.
Aim 5: Biomarker Validation and Prediction Model Development Candidate phenotypes and endotypes will be externally validated using registered, ethically approved biobanks. Validated biomarkers will be correlated with clinically meaningful outcomes, such as treatment responses, to enable their use in stratified medicine. Clinical data and validated biomarkers will be integrated to construct and validate prediction models for exacerbation frequency, time to first exacerbation, and lung function decline.
Participants will visit the Clinical Research Centre at least once for sampling and clinical data collection, with consent obtained to link their samples to the C-BRIDGE database.
Ethics Approval:
Approved by the Ethics Committee of Shanghai Pulmonary Hospital and other participating centers.
Expected Outcomes:
The C-BRIDGE Study will establish detailed molecular endotypes of bronchiectasis in Chinese patients, facilitating precise prognosis prediction and tailored treatment strategies. By identifying and validating patient subgroups and biomarkers, it will provide a foundation for personalized medicine in bronchiectasis management, with potential relevance in China and worldwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bronchiectasis | – | –Adult patients diagnosed with bronchiectasis who meet the study's inclusion criteria |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with bronchiectasis
Key inclusion criteria (2 listed)
- A prior CT scan confirming bronchiectasis, accompanied by a compatible clinical syndrome including cough, sputum production, and/or recurrent respiratory tract infections.
- At the screening visit, participants must have been clinically stable for 4 weeks, defined as no antibiotic or corticosteroid treatment for a pulmonary exacerbation in the preceding 4 weeks.
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Age under 18 years
- Patients with active tuberculosis
- Use of antibiotics or corticosteroids for a pulmonary exacerbation within the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of bronchiectasis exacerbations
Time frame: 2 years
Worsening of respiratory symptoms, as defined by the EMBARC/BRR criteria (Eur Respir J. 2017;49(6):1700051), requiring adjustments to treatment strategies.
10 secondary outcomes
Time to the first exacerbation
Time frame: 2 years
The Quality of Life Bronchiectasis Respiratory Symptom Scales (QOL-B-RSS)
Time frame: 2 years
The Bronchiectasis Health Questionnaire (BHQ)
Time frame: 2 years
The Bronchiectasis Impact Measure (BIM)
Time frame: 2 years
The St Georges Respiratory Questionnaire (SGRQ)
Time frame: 2 years
The bronchiectasis exacerbation and symptom tool (BEST)
Time frame: 2 years
Bronchiectasis Symptom VAS (BS-VAS)
Time frame: 2 years
Forced expiratory volume in 1 second (FEV1)
Time frame: 2 years
Hospitalization for severe exacerbations
Time frame: 2 years
All cause mortality
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 38717347Gao Y, Richardson H, Dicker AJ, Barton A, Kuzmanova E, Shteinberg M, Perea L, Goeminne PC, Cant E, Hennayake C, Pollock J, Abo Leyah H, Choi H, Polverino E, Blasi F, Welte T, Aliberti S, Long M, Shoemark A, Sibila O, Huang JTJ, Chalmers JD. Endotypes of Exacerbation in Bronchiectasis: An Observational Cohort Study. Am J Respir Crit Care Med. 2024 Jul 1;210(1):77-86. doi: 10.1164/rccm.202310-1729OC.
- Background: PubMed 37769155Choi H, Ryu S, Keir HR, Giam YH, Dicker AJ, Perea L, Richardson H, Huang JTJ, Cant E, Blasi F, Pollock J, Shteinberg M, Finch S, Aliberti S, Sibila O, Shoemark A, Chalmers JD. Inflammatory Molecular Endotypes in Bronchiectasis: A European Multicenter Cohort Study. Am J Respir Crit Care Med. 2023 Dec 1;208(11):1166-1176. doi: 10.1164/rccm.202303-0499OC.
- Background: PubMed 35050830Shoemark A, Shteinberg M, De Soyza A, Haworth CS, Richardson H, Gao Y, Perea L, Dicker AJ, Goeminne PC, Cant E, Polverino E, Altenburg J, Keir HR, Loebinger MR, Blasi F, Welte T, Sibila O, Aliberti S, Chalmers JD. Characterization of Eosinophilic Bronchiectasis: A European Multicohort Study. Am J Respir Crit Care Med. 2022 Apr 15;205(8):894-902. doi: 10.1164/rccm.202108-1889OC.
- Background: PubMed 29357265Chalmers JD, Aliberti S, Filonenko A, Shteinberg M, Goeminne PC, Hill AT, Fardon TC, Obradovic D, Gerlinger C, Sotgiu G, Operschall E, Rutherford RM, Dimakou K, Polverino E, De Soyza A, McDonnell MJ. Characterization of the "Frequent Exacerbator Phenotype" in Bronchiectasis. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1410-1420. doi: 10.1164/rccm.201711-2202OC.
- Background: PubMed 35436182Huang JT, Cant E, Keir HR, Barton AK, Kuzmanova E, Shuttleworth M, Pollock J, Finch S, Polverino E, Bottier M, Dicker AJ, Shoemark A, Chalmers JD. Endotyping Chronic Obstructive Pulmonary Disease, Bronchiectasis, and the "Chronic Obstructive Pulmonary Disease-Bronchiectasis Association". Am J Respir Crit Care Med. 2022 Aug 15;206(4):417-426. doi: 10.1164/rccm.202108-1943OC.
- Background: PubMed 35728977Shoemark A, Griffin H, Wheway G, Hogg C, Lucas JS; Genomics England Research Consortium; Camps C, Taylor J, Carroll M, Loebinger MR, Chalmers JD, Morris-Rosendahl D, Mitchison HM, De Soyza A; Genomics England Research Consortium:; Brown D, Ambrose JC, Arumugam P, Bevers R, Bleda M, Boardman-Pretty F, Boustred CR, Brittain H, Caulfield MJ, Chan GC, Fowler T, Giess A, Hamblin A, Henderson S, Hubbard TJP, Jackson R, Jones LJ, Kasperaviciute D, Kayikci M, Kousathanas A, Lahnstein L, Leigh SEA, Leong IUS, Lopez FJ, Maleady-Crowe F, McEntagart M, Minneci F, Moutsianas L, Mueller M, Murugaesu N, Need AC, O'Donovan P, Odhams CA, Patch C, Perez-Gil D, Pereira MB, Pullinger J, Rahim T, Rendon A, Rogers T, Savage K, Sawant K, Scott RH, Siddiq A, Sieghart A, Smith SC, Sosinsky A, Stuckey A, Tanguy M, Taylor Tavares AL, Thomas ERA, Thompson SR, Tucci A, Welland MJ, Williams E, Witkowska K, Wood SM. Genome sequencing reveals underdiagnosis of primary ciliary dyskinesia in bronchiectasis. Eur Respir J. 2022 Nov 17;60(5):2200176. doi: 10.1183/13993003.00176-2022. Print 2022 Nov.
- Background: PubMed 28596426Hill AT, Haworth CS, Aliberti S, Barker A, Blasi F, Boersma W, Chalmers JD, De Soyza A, Dimakou K, Elborn JS, Feldman C, Flume P, Goeminne PC, Loebinger MR, Menendez R, Morgan L, Murris M, Polverino E, Quittner A, Ringshausen FC, Tino G, Torres A, Vendrell M, Welte T, Wilson R, Wong C, O'Donnell A, Aksamit T; EMBARC/BRR definitions working group. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017 Jun 8;49(6):1700051. doi: 10.1183/13993003.00051-2017. Print 2017 Jun.
- Background: PubMed 26846833Aliberti S, Lonni S, Dore S, McDonnell MJ, Goeminne PC, Dimakou K, Fardon TC, Rutherford R, Pesci A, Restrepo MI, Sotgiu G, Chalmers JD. Clinical phenotypes in adult patients with bronchiectasis. Eur Respir J. 2016 Apr;47(4):1113-22. doi: 10.1183/13993003.01899-2015. Epub 2016 Feb 4.
- Background: PubMed 27730179Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, Dimakou K, Clifton I, van der Eerden M, Rohde G, Murris-Espin M, Masefield S, Gerada E, Shteinberg M, Ringshausen F, Haworth C, Boersma W, Rademacher J, Hill AT, Aksamit T, O'Donnell A, Morgan L, Milenkovic B, Tramma L, Neves J, Menendez R, Paggiaro P, Botnaru V, Skrgat S, Wilson R, Goeminne P, De Soyza A, Welte T, Torres A, Elborn JS, Blasi F. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res. 2016 Jan 20;2(1):00081-2015. doi: 10.1183/23120541.00081-2015. eCollection 2016 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong-hua Gao, Ph.D. principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong-hua Gao, Ph.D. (+86 17321278520, gaoyonghuahust@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of bronchiectasis exacerbations (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06900062, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.