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Induced Changes in Ventilatory Responsiveness and Altitude Exposure

This study has been terminated.
(Results of preliminary analyses showed no reason to continue the study)
Sponsor:
Information provided by (Responsible Party):
United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01241513
First received: November 12, 2010
Last updated: May 17, 2016
Last verified: May 2016
Results First Received: October 22, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Effects of High Altitude
Hypoxia
Inadequate or Impaired Breathing Pattern or Ventilation
Abnormal Blood Oxygen Pressure
Interventions: Drug: NAC
Drug: Placebo

  Participant Flow
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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
  Description
N-acetylcysteine Active drug group
Placebo Placebo

Participant Flow:   Overall Study
    N-acetylcysteine     Placebo  
STARTED     10     9  
COMPLETED     10 [1]   9  
NOT COMPLETED     0     0  
[1] Study has been completed



  Baseline Characteristics
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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
  Description
N-acetylcysteine (NAC) NAC
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    N-acetylcysteine (NAC)     Placebo     Total  
Number of Participants  
[units: participants]
  10     9     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     9     19  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  22  (3)     22  (3)     22  (3)  
Gender  
[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
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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
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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
e-mail: charles.fulco@us.army.mil



Responsible Party: United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT01241513     History of Changes
Other Study ID Numbers: H10-13
Study First Received: November 12, 2010
Results First Received: October 22, 2012
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration