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Rapid Acclimatization to Hypoxia at Altitude

Information source: Colorado State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Physiological Function in Low Oxygen Environment

Intervention: Placebo (Drug); Aminophylline (Drug); Methazolamide (Drug); Aminophylline+Methazolamide (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Colorado State University

Official(s) and/or principal investigator(s):
Christopher Bell, PhD, Principal Investigator, Affiliation: Colorado State University


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.

Clinical Details

Official title: Rapid Acclimatization to Hypoxia at Altitude

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


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.

Locations and Contacts

Colorado State University, Dept. of Health and Exercise Science, Fort Collins, Colorado 80523-1582, United States
Additional Information

Department of Health and Exercise Science, Colorado State University

Initial Safety Trial For Treatments Under Investigation In Current Study

Starting date: June 2012
Last updated: October 23, 2014

Page last updated: August 23, 2015

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