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Induced Changes in Ventilatory Responsiveness and Altitude Exposure

NCT01241513 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-04-30

Study results available
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Summary

The main purpose of this study is to determine if a drug (acetyl-cysteine or ACCY) can increase the amount of oxygen in your body at a high altitude of 11,500 feet. ACCY is approved by the Food and Drug Administration (FDA) as a treatment or antidote for Tylenol overdoses. Other forms of ACCY are also sold over-the-counter as nutritional supplements. In this study, the FDA-approved form of ACCY will be used "off-label" (meaning in a way not approved by the FDA).

This study is being conducted by researchers from the United States Army Research Institute of Environmental Medicine (USARIEM). The study will take place in the Altitude Chamber located in the basement of USARIEM. A total of approximately 30 volunteers (men and women, military and civilians) will take part in the study. They can expect to be in the study for a minimum of a few hours each day for two weeks.

The investigators hypothesize that ACCY will improve ventilation and oxygenation while at altitude.

Conditions

  • Effects of High Altitude
  • Hypoxia
  • Inadequate or Impaired Breathing Pattern or Ventilation
  • Abnormal Blood Oxygen Pressure

Interventions

DRUG

NAC

NAC provided to determine if beneficial at altitude

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • United States Army Research Institute of Environmental Medicine

    lead FED

Principal Investigators

  • Charles S Fulco, ScD · United States Army Research Institute of Environmental Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-01
Primary Completion
2011-05-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241513 on ClinicalTrials.gov