Drug Combination on Exercise Performance at High Altitude

University of Montana

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Mountain Sickness

Treatments: Drug: placebo; Drug: ambrisentan and theophylline

Study type: Interventional

Funder types: Other

Identifiers

NCT01902758

UM82-13

N66001-10-C-2134

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy males

Exclusion criteria

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

Trial design

28 participants in 2 patient groups, including a placebo group

ambrisentan and theophylline

Experimental group

Description:

ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days

Treatment:

Drug: ambrisentan and theophylline

placebo

Placebo Comparator group

Description:

matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group

Treatment:

Drug: placebo