Inhaled Budesonide for Altitude Illness Prevention

• Status: Withdrawn
• Trial end date: 2017-03-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Budesonide

Criteria

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)