Inhaled Budesonide for Altitude Illness Prevention
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Incidence of Acute Mountain Sickness (AMS)
研究概览
简要总结
A randomized, double-blinded study administering budesonide, a medication to reduce inflammation in the lungs, to healthy volunteers to examine effects on altitude illness prevention by spending 18 hours overnight at 14,000 ft elevation.
详细描述
A randomized, double-blinded study will be conducted to validate the results of previous literature on the use of budesonide in the prevention of altitude sickness. It will be conducted using healthy participants overseen by experienced wilderness medicine and altitude researchers from the Altitude Research Center at University of Colorado Denver. Participants will be recruited from the Denver community and prescreened for eligibility via phone. 100 participants, after consenting, will have baseline data and blood collected and will begin budesonide therapy 72 hours prior to being taken from Denver to Pikes Peak, where they will be observed at altitude for 18 hours. Patients will have the opportunity to withdraw consent at any time and will be monitored continuously by physician-researchers. Data collection and blood draws will be performed at specific time points and analyzed for efficacy of budesonide vs. placebo in the incidence of altitude sickness.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, altitude naive, 21-40 years old
排除标准
- •pregnancy
- •hx of asthma
- •current inhaled steroid use
- •those with diseases or disorders known to be affected by hypoxia or the drugs used in this study such as
- •migraine or other chronic headaches,
- •sickle cell trait or disease, or
- •history of significant head injury or seizures
- •taking any medication (over-the-counter or prescription) or herbal supplements
- •a known hypersensitivity reaction to budesonide
- •inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day
- •exposure to high altitude above 2000m in the previous 1 month or
- •those who have been on an airline flight over six hours (Airplane cabins are pressurized to an elevation that can approximate exposure to high altitude)
研究组 & 干预措施
Budesonide
Will participate in all study activities but will receive budesonide.
干预措施: Budesonide (Drug)
Placebo
Will participate in all study activities but will receive placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Acute Mountain Sickness (AMS)
时间窗: During 18 hours at elevation compared to baseline.
Comparison of incidence and severity of acute mountain sickness between budesonide and placebo.
Changes in Inflammation
时间窗: During 18 hours at elevation compared to baseline.
Analysis to compare activity in pro-inflammatory pathways and activity in anti-permeability pathways, as measured by serum markers, between budesonide and placebo.
Changes in Gene regulation
时间窗: During 18 hours at elevation compared to baseline.
Comparison of gene regulation involved in acclimatization and altitude illness.
次要结局
未报告次要终点