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

History of Changes

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
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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.
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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 ]

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Serious Adverse Events

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Other Adverse Events

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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

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