Bronchial Infections in Patients With Non-Cystic Fibrosis (CF) Bronchiectasis; Role of Innate Lung Defense Mechanisms and Utility of an Electronic Nose for Its Diagnosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in sputum mucin levels at 12 months
研究概览
简要总结
The purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial peptides and Toll-like receptors is altered in certain patients with non-CF bronchiectasis, which makes them more susceptible to be infected by potentially pathogenic bacteria (PPB); and 2) the electronic nose is able to detect patterns of specific Volatile Organic Compounds (VOC) for patients with non-CF bronchiectasis colonized by PPB.
详细描述
Prospective, observational study, which will include 50 patients with non-CF bronchiectasis who will be followed for a period of 12 months. A follow up control will be performed every three months to all patients, consisting in medical record, lung function tests, blood and serum collection, sputum analysis and culture, and collection of exhaled air for analysis using an electronic nose. These tests will also be repeated whenever the patient has an exacerbation. At the beginning and end of the study, a high resolution chest CT will be performed.
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
- •Diagnosis of non- CF bronchiectasis based on at least 1 lobe with bronchial dilatation and compatible clinical symptoms such as cough, sputum production and respiratory infections.
- •Signed informed consent.
排除标准
- •Presence of exacerbation in the last 4 weeks.
- •Antibiotic treatment in the last 4 weeks
- •Use of oral corticosteroids in the last 4 weeks
- •Concomitant terminal illness.
- •Current cigarette smoking
- •Active allergic bronchopulmonary aspergillosis
- •Diagnosis of tuberculosis or active non-tuberculous Mycobacterial infection
结局指标
主要结局
Change from baseline in sputum mucin levels at 12 months
时间窗: Baseline and 12 months
Mucin levels in sputum will be determined with ELISA kits
次要结局
- Change from baseline in sputum mucin levels at 6 months(Baseline and 6 months)
- Change from baseline in sputum mucin levels at 3 months(Baseline and 3 months)
- Change from baseline in sputum mucin levels at 9 months(Baseline and 9 months)