Pharmacological Countermeasures for High Altitude

NCT05300477 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-06HC (M-10910)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, double-blind study is to determine whether erythropoietin (Procrit) and acetazolamide: 1) mitigates altitude-induced decrements in performance at moderate altitude (3,000 m) and 2) mitigates altitude-induced decrements in performance and reduce acute mountain sickness during prolonged exposure to high altitude (4,300 m; 15 days). Volunteers will complete 5 study phases: Phase 1) sea level baseline testing and a moderate altitude exposure; Phase 2) 4 week study intervention - randomly assigned to receive erythropoietin or placebo); Phase 3) 3 1/2 days of acetazolamide and a moderate altitude exposure; Phase 4) high altitude acclimatization - 15 days at Pikes Peak; and Phase 5) two week deacclimatization. Test battery include VO2peak, 3.2 km treadmill time trial, measures of gas exchange and ventilation during rest and exercise, and blood collection.

Conditions

Hypobaric Hypoxia

Outcome Measures

Primary Outcomes (1)

• 3.2 km self-paced treadmill time trial performance

  Time to complete self-paced 3.2 km treadmill time trial (min:sec)

  35 minutes

Secondary Outcomes (17)

• VO2peak

  30 minutes

• Lake Louise Acute Mountain Sickness Score

  10 minutes

• Ventilation rate

  20 minutes

• Percent body fat

  10 minutes

• Oxygen Saturation

  35 minutes

Study Arms (2)

Acetazolamide

EXPERIMENTAL

Acetazolamide (orally) 250 mg twice a day for 3 1/2 days.

Drug: Acetazolamide

Erythropoietin and Acetazolamide

EXPERIMENTAL

Erythropoietin (subcutaneously) 50 IU /kg three times a week for 4 weeks. After the 4 week Erythropoietin, acetazolamide (orally) 250 mg twice a day for 3 1/2 days.

Drug: Acetazolamide; Drug: Erythropoietin

Interventions

Acetazolamide DRUG

Carbonic Anhydrase Inhibitor

Also known as: Diamox

Acetazolamide; Erythropoietin and Acetazolamide

Erythropoietin DRUG

Hormone for red blood cell

Also known as: Procrit

Erythropoietin and Acetazolamide

Eligibility Criteria

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

You may qualify if:

• Age 18-40 years
• In good health as determined by the Office of Medical Support \& Oversight (OMSO) General Medical Clearance
• Runs at least 3 times per week and able to complete a two mile run in ≤ 21 minutes (Civilian Volunteers) or passed his/her most recent Army Combat Fitness Test (ACFT) (Military Volunteers Only)
• Willing to not exercise, or drink alcoholic and/or caffeinated beverages 24 hours prior to each testing session or the acute altitude exposure to 3,000 m
• Abstain from alcoholic beverages during the 15 day residence at the summit of Pikes Peak
• Abstain from drinking alcohol or caffeine at least 24 hours before a testing session during Phases 1 and 3
• Willing to stay and exercise in an altitude chamber (the size of a dorm room) for \~2.5 hours
• Wiling to reside at the summit of Pikes Peak (4,300 m altitude) and share dormitory area (bunk area, shower, and bathroom), potentially with people of the opposite sex for 15 days
• Up to date on COVID-19 vaccination

You may not qualify if:

• Women who are pregnant or planning to become pregnant during the study
• Taking prescription medication, or over-the-counter medications other than contraceptives, unless approved by OMSO \& PI
• Born at altitudes greater than 2,100 m (7,000 ft)
• Living in areas that are more than 1,200 m (4,000 ft) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
• Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)
• Musculoskeletal injuries that compromise the ability to walk/run on a treadmill or hike steep terrain
• Abnormal blood count in accordance with OMSO - Normal Hb men: 12.6-17.7 g·dL-1 and women: 11.1-15.9 g·dL-1 or Normal Hct men: 37.5-48% and women: 34.0-45%, or presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)
• Any history of malignancy
• Personal or family history of blood clots
• Abnormal prothrombin time/partial thromboplastin time (PT/PTT) test or problems with blood clotting
• History of thromboembolic disease, hypertension, and known risk factors of cardiovascular disease
• Blood donation within 8 weeks of beginning the study
• History of seizures
• History of inflammatory bowel disease
• Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead
• University of Puget Sound: collaborator

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Interventions

Acetazolamide; Erythropoietin; Epoetin Alfa

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Roy Salgado, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Investigators will be blinded to who receives erythropoietin and placebo. Medical providers and a subset of staff will be aware of participants receiving erythropoietin and placebo. Participants, Investigators, and Medical Providers will all be aware of participants administered acetazolamide.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will use a double-blind randomized study design in which one group will receive erythropoietin and the other group will receive the placebo for 4 weeks. After the 4 weeks, both groups will receive acetazolamide.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 29, 2022
• Study Start: May 27, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)