The C-BRIDGE Study: China Bronchiectasis Research Involving Databases, Genomics, and Endotyping

NCT06900062 | Recruiting DMC

• 1 other identifier: 2024ZD0529700
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Bronchiectasis Adult

Keywords

bronchiectasis; phenotype; endotype; multi-omics; precision medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (10)

• Time to the first exacerbation

  2 years

• The Quality of Life Bronchiectasis Respiratory Symptom Scales (QOL-B-RSS)

  2 years

• The Bronchiectasis Health Questionnaire (BHQ)

  2 years

• The Bronchiectasis Impact Measure (BIM)

  2 years

• The St Georges Respiratory Questionnaire (SGRQ)

  2 years

Study Arms (1)

Patients with bronchiectasis

Adult patients diagnosed with bronchiectasis who meet the study's inclusion criteria

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with bronchiectasis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (9)

Lin Liu

Guiyang, Guizhou, China

RECRUITING

Lei Song

Changchun, Jilin, China

RECRUITING

Qian Qi

Jinan, Shangdong, China

RECRUITING

He-feng Chen

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Zhou-fang Mei

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Jun She

Shanghai, Shanghai Municipality, 200437, China

RECRUITING

Xue-ling Wu

Shanghai, Shanghai Municipality, 200437, China

RECRUITING

Yong-hua Gao

Shanghai, Shanghai Municipality, 200437, China

RECRUITING

Xiao-long Ma

Jiaxing, Zhejiang, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 38717347 BACKGROUND

• Choi 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.

  PMID: 37769155 BACKGROUND

• Shoemark 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.

  PMID: 35050830 BACKGROUND

• Chalmers 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.

  PMID: 29357265 BACKGROUND

• Huang 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.

  PMID: 35436182 BACKGROUND

• Shoemark 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.

  PMID: 35728977 BACKGROUND

• Hill 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.

  PMID: 28596426 BACKGROUND

• Aliberti 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.

  PMID: 26846833 BACKGROUND

• Chalmers 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.

  PMID: 27730179 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Whole blood, DNA, and plasma 2. Sputum and sputum supernatant 3. Bronchoalveolar lavage fluid (BALF); Bronchial epithelium collected via bronchoscopy 4. Nasal swabs and nasal lavage fluid 5. Urine

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Yong-hua Gao, Ph.D.

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-hua Gao, Ph.D.

CONTACT

+86 17321278520; gaoyonghuahust@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: April 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)