Drug Combination on Exercise Performance at High Altitude

This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.

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Key information

Conditions

Acute Mountain Sickness Altitude Sickness Respiration Disorders Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Montana Center for Work Physiology and Exercise Metabolism

Missoula, Montana, 59812, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy males

Exclusion criteria

VO2max below 45ml/kg/min
currently taking any medication

Treatment and study plan

ambrisentan and theophylline

Drug

Placebo

Drug

placebo for comparison group

Primary outcomes

Time (Minutes) to Complete 2 Miles on a Treadmill

Time frame: after arriving at high altitude (within 1 hour)

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Registry information

Official study title

Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 18, 2013
Registry last updated: Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed