Rapid Acclimatization to Hypoxia at Altitude

Colorado State University (CSU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Physiological Function in Low Oxygen Environment

Treatments: Drug: Methazolamide; Drug: Placebo; Drug: Aminophylline; Drug: Aminophylline+Methazolamide

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01702025

N66001-10-C-2134

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo

Aminophylline

Active Comparator group

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.

Treatment:

Drug: Aminophylline

Methazolamide

Active Comparator group

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.

Treatment:

Drug: Methazolamide

Aminophylline+Methazolamide

Active Comparator group

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.

Treatment:

Drug: Aminophylline+Methazolamide