Molecular Breath Print of COPD Patients With Exacerbations Despite Triple Inhalational Therapy (TripleEX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Exhaled Breath Metabolites
研究概览
简要总结
Determination of specific molecular breath patterns by secondary electrospray ionization mass spectrometry (SESIHRMS) during and 8 weeks after a COPD exacerbation. Furthermore, breath patterns will be assessed for correlation and association with clinical outcomes and treatment.
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
- •Informed consent
- •age >= 18 years
- •staged according to GOLD recommendations
- •GOLD stage 2-4, GOLD ABE classification
- •hospitalization due to COPD exacerbation
- •subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)
- •suitable for follow-up assessment
- •<48 hours after initiation of antibiotic therapy or systemic steroid therapy
排除标准
- •physical or intellectual impairment precluding informed consent or protocol adherence
- •known pregnancy
- •congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect
- •uncontrolled diabetes (e.g. HbA1c >11% or Glc >20mmol/l)
- •acute or chronic pulmonary disease other than COPD
- •renal failure or renal replacement therapy (GFR < 15 mL/min)
结局指标
主要结局
Change in Exhaled Breath Metabolites
时间窗: twice during 8 weeks
Number of exhaled breath features/metabolites that show a change in intensity (unit of features: mass over charge ratio) during vs after COPD exacerbation. Exhaled breath features are measured via mass spectrometer. Change is calculated as feature intensity during COPD exacerbation minus feature intensity after COPD exacerbation (8 weeks after) for each detected exhaled breath feature.
次要结局
- Symptoms(twice during 8 weeks)
- Inflammation(twice during 8 weeks)
- Causative Agents(twice during 8 weeks)
- Treatment(measured once during COPD exacerbation)
研究者
Malcolm Kohler
Prof. Dr. med.
University of Zurich