Rapid Acclimatization to Hypoxia at Altitude

NCT01702025 | Completed Phase 1 Results

• 1 other identifier: N66001-10-C-2134
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Function in Low Oxygen Environment

Keywords

Hypoxia; Altitude; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Aminophylline

ACTIVE COMPARATOR

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.

Drug: Aminophylline

Methazolamide

ACTIVE COMPARATOR

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.

Drug: Methazolamide

Aminophylline+Methazolamide

ACTIVE COMPARATOR

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.

Drug: Aminophylline+Methazolamide

Interventions

Placebo DRUG

Yellow corn meal in gel capsules

Also known as: Yellow corn meal

Placebo

Aminophylline DRUG

National Drug Code (NDC) 0143-1020-01

Also known as: Theophylline

Aminophylline

Methazolamide DRUG

NDC 0781-1072-01

Also known as: Neptazane

Methazolamide

Aminophylline+Methazolamide DRUG

NDC 0143-1020-01 and NDC 0781-1072-01

Also known as: Theophylline + Neptazane

Aminophylline+Methazolamide

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• normotensive (i.e. \<140/90 mmHg)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead
• Defense Advanced Research Projects Agency: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Location

Related Publications (1)

• 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.

  PMID: 26680684 DERIVED

Related Links

• Department of Health and Exercise Science, Colorado State University
• Initial Safety Trial For Treatments Under Investigation In Current Study

MeSH Terms

Conditions

Hypoxia; Motor Activity

Interventions

Aminophylline; Theophylline; Methazolamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Alkaloids; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Christopher Bell, Ph.D.
• Organization: Department of Health and Exercise Science

christopher.bell@colostate.edu

(970) 491-7522

Study Officials

• Christopher Bell, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 24, 2014
• Results First Posted: October 24, 2014

Record last verified: 2014-10

Locations

US (1)