Effects of Intermittent Hypoxia on the Asthmatic Inflammation of Asthma Patients - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in forced exhaled nitric oxide after 6 days of hypoxia/sham
研究概览
简要总结
Stable Asthma patients (GINA 1-2) stay 6 days in a row for 4 hours per day in a hypoxic chamber simulating 2800m above sea level. Study participants will be blinded to the treatment given and divided into a hypoxic and a sham group (about 360m above sea level).
Effects of this intermittent hypoxia on the asthmatic inflammation of these patients will be measured. The primary endpoint is the change in forced exhaled nitric oxide (FeNO) before and after the study. Secondary endpoints include blood parameters, lung function testing and questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •stable Asthma (GINA 1-2)
排除标准
- •autoimmune disease
- •unstable Asthma (GINA 3-4)
- •history of pneumonia/fever within 3 months
- •place of residence >1000m above sea level
- •trip/vacation above >2500m within 4 weeks
- •cystic fibrosis
- •diabetes mellitus
- •immunodeficiency
- •atopic dermatitis
- •ciliary dyskinesia
- •pregnancy
- •chronic obstructive pulmonary disease
- •history of smoking (>1py)
- •immunosuppression / systemic corticosteroids within 3 months
- •cardiovascular diseases
- •interstitial lung disease
- •bronchopulmonary dysplasia
研究组 & 干预措施
hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: hypoxia in hypoxic chamber (Device)
hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Pulse oximetry (Procedure)
hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Asthma and Quality of Life Questionnaires (Other)
hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Lung function testing (Procedure)
hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Blood taking (Procedure)
hypoxia
The hypoxia group receives normobaric hypoxic air while sitting in a hypoxic chamber simulating 2800 meter above sea level.
Interventions: hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: FeNO measurement (Procedure)
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: sham hypoxia in hypoxic chamber (Device)
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Pulse oximetry (Procedure)
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Asthma and Quality of Life Questionnaires (Other)
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Lung function testing (Procedure)
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: Blood taking (Procedure)
sham hypoxia
The sham group receives normal air while sitting in a hypoxic chamber in about 360 meter above sea level (Graz, Austria).
Interventions: sham hypoxia in hypoxic chamber, asthma and Quality of Life Questionnaires, lung function testing, blood taking, FeNO measurement, pulse oximetry
干预措施: FeNO measurement (Procedure)
结局指标
主要结局
Change in forced exhaled nitric oxide after 6 days of hypoxia/sham
时间窗: 1 week
Forced exhaled nitric oxide will be measured every day before and after the treatment
次要结局
- Change in lung function parameters after 6 days of hypoxia/sham(1 week)
- Change in blood parameters after 6 days of hypoxia/sham(1 week)
- Change in Quality of Life and Asthma questionnaires after 6 days of hypoxia/sham(1 week)
- Change in finger pulse oximetry(1 week)