COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Drug Combination on Exercise Performance at High Altitude

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01902758
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : January 25, 2016
Last Update Posted : February 26, 2016
Information provided by (Responsible Party):
Brent Ruby, University of Montana

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Mountain Sickness Drug: ambrisentan and theophylline Drug: placebo Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude
Study Start Date : August 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: ambrisentan and theophylline
ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
Drug: ambrisentan and theophylline
Placebo Comparator: placebo
matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
Drug: placebo
placebo for comparison group

Primary Outcome Measures :
  1. Time (Minutes) to Complete 2 Miles on a Treadmill [ Time Frame: after arriving at high altitude (within 1 hour) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy males

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01902758

Layout table for location information
United States, Montana
Montana Center for Work Physiology and Exercise Metabolism
Missoula, Montana, United States, 59812
Sponsors and Collaborators
University of Montana
Layout table for additonal information
Responsible Party: Brent Ruby, Director of the Montana Center for Work Physiology and Exercise Metabolism, University of Montana Identifier: NCT01902758    
Other Study ID Numbers: UM82-13
N66001-10-C-2134 ( Other Grant/Funding Number: DARPA )
First Posted: July 18, 2013    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Brent Ruby, University of Montana:
exercise performance
Additional relevant MeSH terms:
Layout table for MeSH terms
Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antihypertensive Agents