The C-BRIDGE Study: China Bronchiectasis Research Involving Databases, Genomics, and Endotyping
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 9
- 主要终点
- Frequency of bronchiectasis exacerbations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Frequency of bronchiectasis exacerbations
时间窗: 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.
次要结局
- 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)
- The bronchiectasis exacerbation and symptom tool (BEST)(2 years)
- Bronchiectasis Symptom VAS (BS-VAS)(2 years)
- Forced expiratory volume in 1 second (FEV1)(2 years)
- Hospitalization for severe exacerbations(2 years)
- All cause mortality(3 years)
研究者
Gao Yong-hua
Associate Professor
Shanghai Pulmonary Hospital, Shanghai, China