NCT02941510

Inhaled Budesonide for Altitude Illness Prevention

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Altitude Sickness

Interventions

Type	Name	Description
DRUG	Budesonide	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.
OTHER	Placebo	Subject(s) will participate in all study activities but will receive placebo.

Timeline

• Start date: 2017-03-06
• Primary completion: 2017-03-06
• Completion: 2017-03-06
• First posted: 2016-10-21
• Last updated: 2017-03-13