Clinical Trial: Inhaled Budesonide for Altitude Illness Prevention

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Inhaled Budesonide for Altitude Illness Prevention

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 Summary: 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.
Sponsor: University of Colorado, Denver

Current Primary Outcome:

• Changes in Inflammation [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: During 18 hours at elevation compared to baseline. ]
  Comparison of gene regulation involved in acclimatization and altitude illness.

Original Primary Outcome:

• Inflammation [ Time Frame: 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.
• AMS [ Time Frame: During 18 hours at elevation compared to baseline. ]
  Comparison of incidence and severity of acute mountain sickness between budesonide and placebo.
• Gene regulation [ Time Frame: During 18 hours at elevation compared to baseline. ]
  Comparison of gene regulation involved in acclimatization and altitude illness.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Colorado, Denver

Dates:
Date Received: October 19, 2016
Date Started: March 6, 2017
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017