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OpenTrials
Completed

NCT Number: NCT01702025

Rapid Acclimatization to Hypoxia at Altitude

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Yellow corn meal in gel capsules

Other names: Yellow corn meal

Aminophylline

Drug

National Drug Code (NDC) 0143-1020-01

Other names: Theophylline

Methazolamide

Drug

NDC 0781-1072-01

Other names: Neptazane

Aminophylline+Methazolamide

Drug

NDC 0143-1020-01 and NDC 0781-1072-01

Other names: Theophylline + Neptazane

Primary outcomes

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

    Time frame: The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia

    After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • Defense Advanced Research Projects Agency
  • University of Colorado, Denver

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2012
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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