Induced Changes in Ventilatory Responsiveness and Altitude Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241513
Recruitment Status : Terminated (Results of preliminary analyses showed no reason to continue the study)
First Posted : November 16, 2010
Results First Posted : May 18, 2016
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Effects of High Altitude
Inadequate or Impaired Breathing Pattern or Ventilation
Abnormal Blood Oxygen Pressure
Interventions: Drug: NAC
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2 participants withdrew prior to any testing

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
N-acetylcysteine Active drug group
Placebo Placebo

Participant Flow:   Overall Study
    N-acetylcysteine   Placebo
STARTED   10   9 
COMPLETED   10 [1]   9 
[1] Study has been completed

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
N-acetylcysteine (NAC) NAC
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   N-acetylcysteine (NAC)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   19 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   9   19 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 22  (3)   22  (3)   22  (3) 
[Units: Participants]
Female   1   1   2 
Male   9   8   17 
Region of Enrollment 
[Units: Participants]
United States   10   9   19 

  Outcome Measures

1.  Primary:   Arterial Oxygen Saturation   [ Time Frame: Day 4 of treatment during acute altitude exposure ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated due to results of preliminary analyses.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Charles S Fulco, PI
Organization: USARIEM
phone: 508 233-4893

Responsible Party: United States Army Research Institute of Environmental Medicine Identifier: NCT01241513     History of Changes
Other Study ID Numbers: H10-13
First Submitted: November 12, 2010
First Posted: November 16, 2010
Results First Submitted: October 22, 2012
Results First Posted: May 18, 2016
Last Update Posted: May 18, 2016