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临床试验/NCT06751550
NCT06751550已完成不适用

Change in Daily FeNO During Three Weeks of Inpatient Pulmonary Rehabilitation in Patients with Asthma

Schön Klinik Berchtesgadener Land1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Fractional Exhaled Nitric Oxide (FeNO) at rest

研究概览

简要总结

This study investigates the use of fractional exhaled nitric oxide (FeNO) measurement to monitor non-pharmacological therapy during a three-week inpatient rehabilitation programme for asthma patients. It compares FeNO levels (measured three times a day) with clinical parameters and quality of life to analyse daily fluctuations and the acute effect of exercise training on FeNO levels. As FeNO is a non-invasive biomarker of airway inflammation, this study aims to expand its role in therapy monitoring and explore its application in a rehabilitation setting.

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

入选标准

  • confirmed diagnosis of bronchial asthma (all disease severities)
  • Chronic Obstructive Pulmonary Disease (COPD) with an asthma component, where the asthma component plays a clinically relevant role
  • written informed consent

排除标准

  • Chronic Obstructive Pulmonary Disease (COPD) as the primary disease
  • unability to perform FeNO measurement independently

结局指标

主要结局

Fractional Exhaled Nitric Oxide (FeNO) at rest

时间窗: From enrollment to the end of rehabilitation at 3 weeks. Daily measurements at 9AM; 1PM; 5PM

Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)

Fractional Exhaled Nitric Oxide (FeNO) before/after exercise

时间窗: From enrollment to the end of rehabilitation at 3 weeks, FeNO measurements will be done before and after a bicycle endurance training

Measurement of FeNo will be done with the Vivatmo Me device (by Bosch Health Care Solutions GmbH)

次要结局

  • Asthma control(On admission and discharge from the 3-week rehabilitation programme)
  • Lung function(On admission and discharge from the 3-week rehabilitation programme)
  • Eosinophils(On admission and discharge from the 3-week rehabilitation programme)
  • C-reactive protein(On admission and discharge from the 3-week rehabilitation programme)
  • Immunoglobulin E (IgE)(On admission and discharge from the 3-week rehabilitation programme)
  • 6-minute walk test(On admission and discharge from the 3-week rehabilitation programme)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Andreas Rembert Koczulla

Professor

Schön Klinik Berchtesgadener Land

研究点 (1)

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