Altitude Sickness
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBudesonide
Budesonide is FDA approved for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). It works by reducing lung inflammation to increase oxygen uptake by the body. The researchers are examining if this medication can prevent altitude sickness.
OTHERPlacebo
Subject(s) will participate in all study activities but will receive placebo.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy, altitude naive, 21-40 years old
Exclusion criteria
* smokers * 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 * diabetes * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Inflammation | 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. |
| Incidence of Acute Mountain Sickness (AMS) | During 18 hours at elevation compared to baseline. | Comparison of incidence and severity of acute mountain sickness between budesonide and placebo. |
| Changes in Gene regulation | During 18 hours at elevation compared to baseline. | Comparison of gene regulation involved in acclimatization and altitude illness. |
Outcome results
None listed