Rapid Acclimatization to Hypoxia at Altitude

This study has been completed.
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
University of Colorado, Denver
Information provided by (Responsible Party):
Christopher Bell, Colorado State University
ClinicalTrials.gov Identifier:
NCT01702025
First received: October 3, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Physiological Function in Low Oxygen Environment
Drug: Treatment 1 Theophylline
Drug: Treatment 3 Theophylline and Neptazane
Drug: Treatment 2 Neptazane
Drug: Treatment 4 Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Rapid Acclimatization to Hypoxia at Altitude

Resource links provided by NLM:


Further study details as provided by Colorado State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100W, 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.


Enrollment: 19
Study Start Date: June 2012
Study Completion Date: June 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normoxia
Treatment 1, Treatment 2, Treatment 3, Treatment 4
Drug: Treatment 1 Theophylline
single 400 mg dose of Aminophylline
Other Name: Theophylline
Drug: Treatment 3 Theophylline and Neptazane
single 400 mg dose of Aminophylline and single 250mg dose of Methazolamide
Other Name: Theophylline and Neptazane
Drug: Treatment 2 Neptazane
single 250 mg dose of Methazolamide
Other Name: Neptazane
Drug: Treatment 4 Placebo
single Placebo dose
Active Comparator: Hypoxia
Treatment 2, Treatment 1, Treatment 3, Treatment 4
Drug: Treatment 1 Theophylline
single 400 mg dose of Aminophylline
Other Name: Theophylline
Drug: Treatment 3 Theophylline and Neptazane
single 400 mg dose of Aminophylline and single 250mg dose of Methazolamide
Other Name: Theophylline and Neptazane
Drug: Treatment 2 Neptazane
single 250 mg dose of Methazolamide
Other Name: Neptazane
Drug: Treatment 4 Placebo
single Placebo dose

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702025

Locations
United States, Colorado
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, United States, 80523-1582
Sponsors and Collaborators
Colorado State University
Defense Advanced Research Projects Agency
University of Colorado, Denver
Investigators
Principal Investigator: Christopher Bell, PhD Colorado State University
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher Bell, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT01702025     History of Changes
Other Study ID Numbers: N66001-10-C-2134
Study First Received: October 3, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Colorado State University:
Hypoxia
Altitude
Exercise

Additional relevant MeSH terms:
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Theophylline
Methazolamide
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Cardiovascular Agents
Carbonic Anhydrase Inhibitors
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on July 23, 2014