Back to resultsRapid Acclimatization to Hypoxia at Altitude
Primary Purpose
Physiological Function in Low Oxygen Environment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Aminophylline
Methazolamide
Aminophylline+Methazolamide
Sponsored by
About this trial
This is an interventional prevention trial for Physiological Function in Low Oxygen Environment focused on measuring Hypoxia, Altitude, Exercise
Eligibility 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.
Sites / Locations
- Colorado State University, Dept. of Health and Exercise Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Aminophylline
Methazolamide
Aminophylline+Methazolamide
Arm Description
Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions. Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.
Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide) Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
Outcomes
Primary Outcome Measures
Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01702025
First Posted
October 3, 2012
Last Updated
October 23, 2014
Sponsor
Colorado State University
Collaborators
Defense Advanced Research Projects Agency, University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01702025
Brief Title
Rapid Acclimatization to Hypoxia at Altitude
Official Title
Rapid Acclimatization to Hypoxia at Altitude
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
Collaborators
Defense Advanced Research Projects Agency, University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Function in Low Oxygen Environment
Keywords
Hypoxia, Altitude, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.
Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.
Arm Title
Aminophylline
Arm Type
Active Comparator
Arm Description
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.
Arm Title
Methazolamide
Arm Type
Active Comparator
Arm Description
Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
Arm Title
Aminophylline+Methazolamide
Arm Type
Active Comparator
Arm Description
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Yellow corn meal
Intervention Description
Yellow corn meal in gel capsules
Intervention Type
Drug
Intervention Name(s)
Aminophylline
Other Intervention Name(s)
Theophylline
Intervention Description
National Drug Code (NDC) 0143-1020-01
Intervention Type
Drug
Intervention Name(s)
Methazolamide
Other Intervention Name(s)
Neptazane
Intervention Description
NDC 0781-1072-01
Intervention Type
Drug
Intervention Name(s)
Aminophylline+Methazolamide
Other Intervention Name(s)
Theophylline + Neptazane
Intervention Description
NDC 0143-1020-01 and NDC 0781-1072-01
Primary Outcome Measure Information:
Title
Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
Description
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.
Time Frame
The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bell, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University, Dept. of Health and Exercise Science
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523-1582
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26680684
Citation
Scalzo RL, Binns SE, Klochak AL, Giordano GR, Paris HL, Sevits KJ, Beals JW, Biela LM, Larson DG, Luckasen GJ, Irwin D, Schroeder T, Hamilton KL, Bell C. Methazolamide Plus Aminophylline Abrogates Hypoxia-Mediated Endurance Exercise Impairment. High Alt Med Biol. 2015 Dec;16(4):331-42. doi: 10.1089/ham.2015.0066.
Results Reference
derived
Links:
URL
http://hes.chhs.colostate.edu/
Description
Department of Health and Exercise Science, Colorado State University
URL
http://clinicaltrials.gov/ct2/show/NCT01587027?term=THE+SAFETY+EVALUATION+OF+AMINOPHYLLINE+AND+METHAZOLAMIDE+WHEN+ADMINISTERED+ORALLY+ALONE+AND+IN+COMBINATION+TO+HEALTHY+VOLUNTEERS&rank=1
Description
Initial Safety Trial For Treatments Under Investigation In Current Study
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Rapid Acclimatization to Hypoxia at Altitude
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