TerminatedPhase 4

Induced Changes in Ventilatory Responsiveness and Altitude Exposure

Stopped: Results of preliminary analyses showed no reason to continue the study

United States21 participantsStarted 2010-11-01

Plain-language 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.

Who can participate

Age range18 Years – 39 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 s…

What they're measuring

Arterial Oxygen Saturation

Timeframe: Day 4 of treatment during acute altitude exposure

Trial details

NCT IDNCT01241513

SponsorUnited States Army Research Institute of Environmental Medicine

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2012-10-22