Clinical trial NCT01702025: Rapid Acclimatization to Hypoxia at Altitude
Official title: Rapid Acclimatization to Hypoxia at Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Physiological Function in Low Oxygen Environment
Keywords: Hypoxia
Altitude
Exercise
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Defense Advanced Research Projects Agency
name: University of Colorado, Denver
First posted: 2012-10-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
timeFrame: The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University, Dept. of Health and Exercise Science
state: Colorado
Study officials:
affiliation: Colorado State University
name: Christopher Bell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.