The BRIDGE Study - Bronchiectasis Research Involving Databases, Genomics and Endotyping. An EMBARC2 and EMBARC3 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Frequency of exacerbations
研究概览
简要总结
Bronchiectasis is a complex heterogeneous disorder. Treatment is challenging and many recent randomized controlled trials have been negative. It is believed that bronchiectasis as a broad diagnosis incorporates multiple different patient subgroups (also known as phenotypes) and molecular entities (referred to as endotypes). This study aims to phenotype and endotype bronchiectasis during stable disease and exacerbations, to develop strategies for personalised medicine.
Primary Objective To determine molecular endotypes of bronchiectasis which can guide response to treatment.
Secondary Objectives
- To determine molecular endotypes of stable bronchiectasis
- To determine the causes and inflammatory profiles of bronchiectasis exacerbations
- To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
- To perform in-vivo or in-vitro proof of concept studies using phenotypic data to identify patient populations likely to benefit in future randomized controlled trials
This is an observational cohort study that will aim to identify patient subgroups and link these with meaningful clinical outcomes.
详细描述
Background: Bronchiectasis is a common disabling and heterogeneous disease that has been neglected in terms of basic and clinical research. Recent controlled trials have failed to achieve their primary end-points, likely because the optimal patient population to benefit from antibiotic, mucoactive and anti-inflammatory drugs has not been identified. This study aims to explore the clinical, microbiological, inflammatory and functional heterogeneity of the disease with the aim of identifying patient endotypes for stratified medicine.
Study aims and objectives
- To determine the molecular endotypes of bronchiectasis during stable disease
- To determine the causes and inflammatory profiles of bronchiectasis exacerbations
- To validate candidate biomarkers of stable and exacerbation endotypes to use in stratified medicine
- To perform in-vivo or in-vitro proof of concept studies using phenotypic data to identify patient populations likely to benefit in future randomized controlled trials Study Design: Observational Cohort study
Study methods:
Patients with bronchiectasis will be recruited into an observational study, the objectives of which will be to:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A previous CT scan showing bronchiectasis along with compatible clinical syndrome of cough, sputum production and/or recurrent respiratory tract infections.
- •A primary diagnosis of bronchiectasis made by a respiratory physician
- •At the screening visit the individual will have been clinically stable for 4 weeks indicated by the lack of any treatment with antibiotics or corticosteroids for a pulmonary exacerbation in the previous 4 weeks.
排除标准
- •Inability to give informed consent
- •<18years of age
- •Patients with active tuberculosis
- •Treatment with antibiotics or corticosteroids for a pulmonary exacerbation in the previous 4 weeks
- •Bronchiectasis due to cystic fibrosis
结局指标
主要结局
Frequency of exacerbations
时间窗: up to 3 years
Worsening of respiratory symptoms as defined by the EMBARC/BRR definition- Eur Respir J. 2017 Jun 8;49(6). pii: 1700051.
次要结局
- Time to first exacerbation(3 years)
- Quality of life- The Bronchiectasis impact measure (BIM)(3 years)
- Quality of life- The Bronchiectasis Health Questionnaire (BHQ)(3 years)
- Quality of life- the St Georges Respiratory Questionnaire (SGRQ)(3 years)
- Forced expiratory volume in 1 second (FEV1)(3 years)
- Severity of disease (the bronchiectasis severity index)(3 years)
- Quality of life- the quality of life bronchiectasis questionnaire (QOL-B)(3 years)
- Infection with Pseudomonas aeruginosa(3 years)
- All cause mortality(3 years)
- Sputum volume(3 years)
- Hospitalisation for severe exacerbations(3 years)
研究者
James Chalmers
Professor
University of Dundee