Inhaled Budesonide for Altitude Illness Prevention

University of Colorado Denver (CU Denver)

Status and phase

Withdrawn

Phase 3

Conditions

Altitude Sickness

Treatments

Other: Placebo

Drug: Budesonide

Study type

Interventional

Funder types

Other

Identifiers

NCT02941510

16-2184

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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)