Induced Changes in Ventilatory Responsiveness and Altitude Exposure

NCT01241513 | Terminated Phase 4 Results DMC

• 1 other identifier: H10-13
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

glutathione; redox status; carotid body chemosensitivity; ventilation

Outcome Measures

Primary Outcomes (1)

• Arterial Oxygen Saturation

  Finger Pulse Oximetry to measure arterial oxygen saturation

  Day 4 of treatment during acute altitude exposure

Study Arms (2)

N-acetyl-L-Cysteine

EXPERIMENTAL

N-Acetyl-L-Cysteine

Drug: NAC

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

NAC DRUG

NAC provided to determine if beneficial at altitude

Also known as: NAC Accy

N-acetyl-L-Cysteine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Altitude Sickness; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Limitations and Caveats

Study terminated due to results of preliminary analyses.

Results Point of Contact

• Title: Charles S Fulco, PI
• Organization: USARIEM

charles.fulco@us.army.mil

508 233-4893

Study Officials

• Charles S Fulco, ScD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: February 28, 2013
• Last Updated: April 30, 2020
• Results First Posted: May 18, 2016

Record last verified: 2020-04

Locations

US (1)