Acetazolamide for Prevention of Acute Mountain Sickness in Healthy Lowlanders Older Than 40 Years. Randomized Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Acute mountain sickness (AMS), incidence
研究概览
简要总结
Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m.
详细描述
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of acute mountain sickness (AMS) in lowlanders older than 40 years travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m.
An interim analysis will be carried out when 80 participants will have completed the study or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, age 40-75 yrs, without any disease and need of medication.
- •Born, raised and currently living at low altitude (<800m).
- •Written informed consent.
- •Kyrgyz ethnicity
排除标准
- •Any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure.
- •Any condition that may interfere with protocol compliance including current heavy smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last 10 years), regular use of alcohol.
- •Allergy to acetazolamide and other sulfonamides.
研究组 & 干预措施
ACETAZOLAMIDE oral capsule
Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m
干预措施: ACETAZOLAMIDE oral capsule (Drug)
PLACEBO oral capsule
Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3'100m until the morning after the second night at 3'100m.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Acute mountain sickness (AMS), incidence
时间窗: Day 1 to 3 at 3'100m
Difference between acetazolamide and placebo group in the incidence of AMS during the stay at 3'100 m.
次要结局
- Altitude related adverse health effects (ARAHE), incidence(Day 1 to 3 at 3'100m)
- Arterial partical pressure of oxygen(Day 2 at 760m and day 2 at 3'100m)
- Acute mountain sickness (AMS), severity assessed by the Lake Louise score(Day 1 to 3 at 3'100m)
- Spirometric measurement of forced expiratory volume in one second(Day 2 at 760m and day 2 at 3'100m)
- Acute mountain sickness (AMS) at 760 m with and without acetazolamide, severity(Day 3 at 760 m)
- Drug side effects(Day 1 to 3 at 3'100m)