Correlation of FeNO, Blood Eosinophils, Bronchoalveolar Lavage Findings and Bronchial Epithelium Histopathology in Patients With Chronic Obstructive Pulmonary Disease and Asthma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.
研究概览
简要总结
Scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and COPD. The primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with FeNO, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.
详细描述
This is a multicenter prospective trial. Enrollment will continue until 150 patients with chronic obstructive pulmonary disease and 50 patients with severe asthma have been entered into this trial and have completed bronchoscopic evaluation. In this trial, the following parameters are to be evaluated:
- Blood eosinophils (absolute and relative)
- FeNO
- Eosinophils in bronchoalveolar lavage
- Tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)
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
- •Patients with diagnosis of COPD or asthma (according to the guidelines)
- •Age >18 years
- •Indication for bronchoscopy for medical reasons (not study-related)
- •Ability to provide informed consent
排除标准
- •paO2 <60 mmHg on 4L 02 /min, paCO2 > 55 mmHg on room air
- •FEV1 <20%
- •Pulmonary infection or exacerbation within the last 4 weeks
- •Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
- •Contraindication for BAL, PSB sampling or endobronchial biopsy
- •Current use of anticoagulants that can not be stopped for bronchoscopy
- •Heart failure with left ventricular ejection fraction <30%
- •Myocardial infarction in previous 6 months
- •Significant pulmonary hypertension (PAPS >45 mmHg, right heart failure [echocardiography] and/or PAPm >35 mmHg [right heart catheter])
结局指标
主要结局
Assessment of eosinophilic inflammation by correlating tissue eosinophilia with eosinophil count in blood/BAL and FeNO measurement.
时间窗: 18 months
Correlation of FeNO, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma
次要结局
未报告次要终点
研究者
Daniela Gompelmann
Daniela Gompelmann, MD
Heidelberg University