Rapid Acclimatization to Hypoxia at Altitude

NCT ID: NCT01702025

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Yellow corn meal in gel capsules

Aminophylline

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.

Group Type: ACTIVE_COMPARATOR

Aminophylline

Intervention Type: DRUG

National Drug Code (NDC) 0143-1020-01

Methazolamide

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.

Group Type: ACTIVE_COMPARATOR

Methazolamide

Intervention Type: DRUG

NDC 0781-1072-01

Aminophylline+Methazolamide

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.

Group Type: ACTIVE_COMPARATOR

Aminophylline+Methazolamide

Intervention Type: DRUG

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

Interventions

Placebo

Yellow corn meal in gel capsules

Intervention Type: DRUG

Aminophylline

National Drug Code (NDC) 0143-1020-01

Intervention Type: DRUG

Methazolamide

NDC 0781-1072-01

Intervention Type: DRUG

Aminophylline+Methazolamide

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

Intervention Type: DRUG

Other Intervention Names

Yellow corn meal; Theophylline; Neptazane; Theophylline + Neptazane

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Defense Advanced Research Projects Agency

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Bell

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Bell, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26680684 (View on PubMed)

Related Links

http://hes.chhs.colostate.edu/

Department of Health and Exercise Science, Colorado State University

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

Initial Safety Trial For Treatments Under Investigation In Current Study

Other Identifiers

N66001-10-C-2134

Identifier Type: -

Identifier Source: org_study_id