NCT02811016已完成1 期
Effect of Inhaled Budesonide on the Incidence and Severity of Acute Mountain Sickness at 4559 m
Salzburger Landeskliniken1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Incidence of acute mountain sickness
研究概览
简要总结
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
- Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
In addition, the secondary study questions to ask are:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
Study medication Inhaled budesonide at 2 different concentrations (2 x 200 µg, 2 x 800 µg) versus placebo
Study design
- Prospective, controlled, single-center study on 51 healthy volunteers at 4559 m [Capanna Regina Margherita (Margherita Hut), Italy]
- With regard to the intervention (inhaled budesonide) double-blinded and randomized
详细描述
Primary objective
The primary objective of the study is to investigate the effect of inhaled budesonide on the incidence of AMS. The primary study question to ask is:
- Does inhaled budesonide reduce the incidence of AMS after rapid and active ascent to 4559 m?
In addition, the secondary study questions to ask are:
- Does inhaled budesonide reduce the severity of AMS after rapid and active ascent to 4559 m?
- Are the effects of inhaled budesonide on AMS incidence and severity related to its plasma concentration?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good physical condition
- •No relevant pathologies revealed by the pre-investigation prior to the study
- •Written informed consent to participate in the study
- •Permanent residency below 1000 m
- •Males and females are included without prioritization
排除标准
- •Acute and chronic lung diseases
- •Conventional systolic blood pressure (average of two measurements) ≥150 mmHg and conventional diastolic blood pressure ≥95 mmHg in untreated or treated subjects
- •Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, peripheral artery disease)
- •Chronic headache / migraine
- •Diabetes mellitus
- •Smoking (>6 cigarettes/day) or equivalent nicotine substitutes
- •Alcohol (>30 g/d) or drug abuse
- •Obesity (Body Mass Index >30)
- •Other conditions deemed relevant by the investigator (including liver disease, renal disease)
- •Sojourn >2000 m within the last 4 weeks before the 1st study day
- •Drug intake within the last 2 moth before the 1st study day if the drug intake could affect the data quality or the safety of the participants
- •Blood donation within the last 2 month before the 1st study day
研究组 & 干预措施
budesonide 200
Experimental
inhaled budesonide 200 µg bid
干预措施: Budesonide 200 (Drug)
budesonide 800
Experimental
inhaled budesonide 800 µg bid
干预措施: Budesonide 800 (Drug)
placebo
Placebo Comparator
inhaled placebo bid
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of acute mountain sickness
时间窗: 48 hrs at 4559 m
AMS scores positive
次要结局
- Severity of acute mountain sickness(48 hrs at 4559 m)
研究者
Marc Berger
PD Dr. med.
Salzburger Landeskliniken
研究点 (1)
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