Rapid Acclimatization to Hypoxia at Altitude
This study is ongoing, but not recruiting participants.
Sponsor:
Colorado State University
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: April 15, 2013
Last verified: April 2013
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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.
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | January 2013 (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
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: | April 15, 2013 |
| 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 May 21, 2013