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临床试验/NCT01760928
NCT01760928已完成不适用

Guidance of Patients With Asthma During Preparation and During Expedition to the Aconcagua Mountain

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
To assess the type of airway inflammation evoked by exercise, hypoxia and cold air

研究概览

简要总结

A selection of asthma patients were followed during preparation to climb the Aconcagua mountain. The primary goal of this follow up was to optimize patients' asthma status. Also during expedition, these patients were daily consulted by a physician. All data obtained during preparation and expedition will now be retrospectively analyzed.

详细描述

Preparation phase:

Eighteen asthma patients were selected based on physical and medical characteristics. During the year of preparation, several time points of evaluation were planned: evaluation at baseline, maximal exercise test in hypoxia (FiO2: 11%), 24hour stay at cold air environment.

At baseline, medical history was evaluated and clinical examination, ECG, lung function, Fraction of exhaled NO measurement and histamine provocation were performed.

During a second visit, patients stayed for approximately one hour in a chamber to simulate high altitude (FiO2:11%) and performed a maximal exercise test after 30 minutes of rest. Oxygen saturation, ECG and oxygen consumption were continuously monitored. Lung function and fraction of exhaled NO were assessed before and after the test. Also, peripheral blood was drawn before and after the test. This test allowed us to identify whether patients may develop acute mountain sickness later on during expedition.

During a third visit, patients stayed for 24 hours in a indoor ski centre to practice climbing techniques, building up a tent and working with the specialized materials. Temperature at the ski piste varies between -5°C and -10°C. Lung function, fraction of exhaled NO and induced sputum was assessed before and after the stay at the ski centre.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • asthma patient
  • positive histamine provocation

排除标准

  • exacerbation during the year prior to inclusion

结局指标

主要结局

To assess the type of airway inflammation evoked by exercise, hypoxia and cold air

时间窗: one year

Sputum cells and cytokine messenger ribonucleic acid will be analyzed to determine the type of airway inflammation that is induced by several triggers (exercise, hypoxia and cold air)

次要结局

  • To predict the occurrence of acute mountain sickness during an expedition to the Aconcagua mountain(one year)

研究者

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

Dr. Lieven Dupont

Prof. dr.

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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