Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
研究概览
简要总结
Patients with persistent asthma have different inflammatory phenotypes. The electronic nose is a new technology capable of distinguishing volatile organic compound breath-prints in exhaled breath among different pulmonary diseases.
Question of the study. Is the electronic nose breath-print analysis able to discriminate among different inflammatory asthma phenotypes?
详细描述
Materials/patients and methods. Fifty-two consecutively enrolled patients with persistent asthma were included in a cross-sectional proof of concept study. Inflammatory asthma phenotypes were recognized by inflammatory cell counts in induced sputum. Breath-prints were analyzed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values. Receiver Operating Characteristics (ROC) was calculated.
Legal and ethical aspects The study was conducted in accordance with the Declaration of Helsinki principles (18th Word Medical Assembly, 1964) and was approved by the Clinical Research Ethics Committee (approval number: IIBSP/10/122/1161) of our institution. The participants provided their written informed consent to participate in this study and personal identification data were anonymized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with persistent asthma, defined as per the Global INitiative for Asthma Management (GINA) criteria, and specifically with positive bronchodilator test, or a daily peak expiratory flow (PEF) variability greater than 20%, or a positive methacholine challenge test documented in case history. Subjects were consecutively enrolled from the outpatient visits of a specialized Asthma Unit located in a tertiary University Hospital.
排除标准
- •Subjects were excluded if they had a respiratory tract infection or asthma exacerbation within 30 days prior to inclusion or were receiving oral steroids or immunosuppressive treatments.
结局指标
主要结局
Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
时间窗: 2 years
The recognition of volatile organic compound profiles in exhaled air by an electronic nose device can discriminate the inflammatory phenotype of patients with persistent asthma.
次要结局
未报告次要终点
研究者
Astrid Crespo
Inflammatory Asthma Phenotypes Discrimination by an Electronic Nose Breath Analyzer
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau