Altitude Sickness Prevention and Efficacy of Comparative Treatments (ASPECT)

This study is designed to be the first to examine the novel drug budesonide for prevention of acute mountain sickness in comparison to acetazolamide and in the context of rapid ascent to high altitude. The investigators will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Altitude Sickness Prevention and Efficacy of Comparative Treatments
Estimated Enrollment: 100
Study Start Date: August 2016
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Budesonide
- Active Comparator: Acetazolamide
- Sham Comparator: Control