Acute Mountain Sickness
Conditions
Keywords
exercise performance
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.
Interventions
DRUGambrisentan and theophylline
DRUGplacebo
placebo for comparison group
Sponsors
University of Montana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy males
Exclusion criteria
* VO2max below 45ml/kg/min * currently taking any medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (Minutes) to Complete 2 Miles on a Treadmill | after arriving at high altitude (within 1 hour) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ambrisentan and Theophylline ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days
ambrisentan and theophylline | 14 |
| Placebo matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group
placebo: placebo for comparison group | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Placebo | Ambrisentan and Theophylline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Continuous | 23 years STANDARD_DEVIATION 2 | 22 years STANDARD_DEVIATION 2 | 23 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Time (Minutes) to Complete 2 Miles on a Treadmill
Time frame: after arriving at high altitude (within 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ambrisentan and Theophylline | Time (Minutes) to Complete 2 Miles on a Treadmill | 1544 seconds | Standard Deviation 109 |
| Placebo | Time (Minutes) to Complete 2 Miles on a Treadmill | 1540 seconds | Standard Deviation 158 |