Skip to content

Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Induced Changes in Ventilatory Responsiveness and Altitude Exposure

NCTNCT01241513 (opens ClinicalTrials.gov in a new tab)Other idH10-13
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glutathione, does not test it. It appears in the summary.

Overview

Status
Terminated
Phase
Phase 4
Enrollment
21 participants (actual)
Sponsor
United States Army Research Institute of Environmental Medicine · Fed
Design
Not randomized · Triple masking
Countries
1 country

United States

Start
1 Nov 2010
Primary completion
May 2011
Completion
28 Feb 2013
First posted
16 Nov 2010 (estimated)
Last update posted
30 Apr 2020
Conditions
Effects of High Altitude · Hypoxia · Inadequate or Impaired Breathing Pattern or Ventilation · Abnormal Blood Oxygen Pressure

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph 4

    Induced Changes in Ventilatory Responsiveness and Altitude Exposure

    NCT01241513

    1 Nov 2010 to 28 Feb 2013

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NACDrug
  • PlaceboDrug

Arms2

  • Experimental

    N-acetyl-L-Cysteine

    N-Acetyl-L-Cysteine

  • Placebo comparator

    Placebo

    placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Arterial Oxygen Saturation

    Time frame · Day 4 of treatment during acute altitude exposure

    Registry description

    Finger Pulse Oximetry to measure arterial oxygen saturation

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 4 of treatment during acute altitude exposure

Arterial Oxygen Saturation

GroupValue (percentage of oxygen saturation)Spread
Placebo Group8210
NAC Group7912

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
NAC Group and Placebo Group–0 / 196 / 19

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 39 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: \- Exclusion Criteria: * Volunteers with the following criteria will be EXCLUDED from participation: Less than 18 years of age Greater than 39 years of age Born at altitudes greater than 2134 m (7000 ft) Living in areas that are more than 1220 m (4,000 feet), or have traveled to areas that are more than 1220 m for more than a few days within the last 2 months. Abnormal \[Hb\]/Hct levels or presence of hemoglobin S Known allergies to sulfonamide derivatives Smokers who smoke more than 5 cigarettes per day Tobacco chewers If military, unable to pass the 2-mi run portion of the Army Physical Fitness Test, or equivalent If civilian, not currently running or exercising for at least 20 min/day, 3X/week in "aerobic" activities (e.g., running, biking. swimming, basketball, etc) If they do not want to walk or run multiple times for 1 to 3 hours on a treadmill Unable to meet the U.S. Army height/weight standards Not willing to sleep in bunk beds in a small room (8 feet by 8 feet) with 1 to 3 other volunteers (male and/or female) for 3 nights. If they are claustrophobic Women who are pregnant or planning to conceive during the study period Women who are not willing to take urine pregnancy tests Not willing to drink an eight ounce solution of diet soda that may contain ACCY up to three times per day and then not willing to suck on a peppermint mint right after drinking the solution. Taking medications that interfere with oxygen delivery and transport (Includes sedatives, sleeping aids, tranquilizers and any medication that depresses ventilation, diuretics, alpha and beta blockers) Evidence of any physical, mental, and/or medical conditions that would make the proposed studies relatively more hazardous. Evidence of prior HAPE or HACE diagnosis Evidence of apnea or other sleeping disorders Evidence of asthma If applicable, unwilling to stop taking all supplements for the two weeks of participation If applicable, all medications (prescription or over-the-counter) must be approved by the PI, and/or the OMSO.

PepBank is a research reference. Talk to a doctor before you use any peptide.