About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Adult patients with bronchiectasis
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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