Altitude Sickness Prevention and Efficacy of Comparative Treatments
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Mountain Sickness
In brief
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.
Key facts
- Study ID
- NCT02604173
- Run by
- Stanford University
- People needed
- 103
- Starts
- 2016-08-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-12-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male and Female
- Sea level-dwelling hikers
- Between ages 18-65
You may not qualify if…
- History of allergy to acetazolamide or budesonide (or other corticosteroids)
- Taken NSAIDs, acetazolamide, or corticosteroids in the one week prior to study enrollment.
- Hazardous medical conditions which precludes the ability to moderately hike to high altitude including: sickle cell anemia, asthma, or COPD, severe anemia, or severe coronary arterial disease.
- Pregnancy or suspected pregnancy.
- Participants who are younger than 18 years of age and more than 65
- Sleep above 4'000 elevation in the preceding 1 week.
- History of asthma or COPD
- Current symptoms of an acute upper respiratory illness.
- Unable to complete a moderately strenuous hike at high altitude.
Where it is running
- Owens Valley Lodge - White Mountain Research Station — Bishop, California, United States
Full record on ClinicalTrials.gov
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