Rapid Acclimatization to Hypoxia at Altitude

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Colorado State University
• Collaborators: Defense Advanced Research Projects Agency; University of Colorado, Denver
• Treatments: Aminophylline; Methazolamide; Theophylline

Criteria

Inclusion Criteria:

• normotensive (i.e. <140/90 mmHg)

Exclusion Criteria:

• Pregnancy

• nursing mother

• current tobacco use or regular use within the previous two years

• use of prescription medication other than birth control

• asthma or any other type of lung/respiratory dysfunction

• resting oxygen saturation <95%

• unwillingness to abstain from exercise for 48 hours prior to laboratory testing

• use of anticoagulant therapy or have a known or suspected bleeding disorder

• identification of contraindication during screening (i.e. positive stress test)

• any history of mountain sickness (altitude sickness)

• any history of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives

• history of clinically significant illness within 4 weeks prior to Day 1

• Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to visit 1

• receipt of a transfusion or any blood products within 30 days prior to visit 1.