CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 103 enrolled
Drug / intervention
Budesonide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02604173
NCT02604173Phase 3Completed
CompareCT.gov

A Randomized Controlled Trial of Altitude Sickness Prevention and Efficacy of Comparative Treatments

Stanford University·interventional·Posted Nov 13, 2015·Updated Dec 12, 2018

In Brief

A Phase 3 clinical trial evaluating Budesonide, Acetazolamide, and 1 other intervention for Acute Mountain Sickness. Completed, enrolled 103 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Mountain Sickness
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartAug 1, 2016
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.6 years ago

Interventions

Budesonidedrug

Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness

Acetazolamidedrug

Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness

Placebodrug

Placebo pill and sham inhaler