Trial Outcomes & Findings for Induced Changes in Ventilatory Responsiveness and Altitude Exposure (NCT NCT01241513)
NCT ID: NCT01241513
Last Updated: 2020-04-30
Results Overview
Finger Pulse Oximetry to measure arterial oxygen saturation
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Day 4 of treatment during acute altitude exposure
Results posted on
2020-04-30
Participant Flow
2 participants withdrew prior to any testing
Participant milestones
| Measure |
N-acetylcysteine
Active drug group
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Induced Changes in Ventilatory Responsiveness and Altitude Exposure
Baseline characteristics by cohort
| Measure |
N-acetylcysteine (NAC)
n=10 Participants
NAC
|
Placebo
n=9 Participants
Placebo
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 3 • n=39 Participants
|
22 years
STANDARD_DEVIATION 3 • n=41 Participants
|
22 years
STANDARD_DEVIATION 3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=39 Participants
|
9 participants
n=41 Participants
|
19 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 4 of treatment during acute altitude exposureFinger Pulse Oximetry to measure arterial oxygen saturation
Outcome measures
| Measure |
Placebo Group
n=9 Participants
Placebo (Diet soda only)
|
NAC Group
n=10 Participants
N-acetyl-L-Cysteine (800 mg T.I.D. in diet soda) for 4 days
|
|---|---|---|
|
Arterial Oxygen Saturation
|
82 percentage of oxygen saturation
Standard Deviation 10
|
79 percentage of oxygen saturation
Standard Deviation 12
|
Adverse Events
NAC Group and Placebo Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NAC Group and Placebo Group
n=19 participants at risk
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Delayed patella tendon soreness
|
5.3%
1/19 • Number of events 1
Adverse events can not be reported by intervention group because the data were not unblinded for data analyse. Based on results of preliminary analyses, the blind was not broken to further parse out the data for adverse events.
|
|
Musculoskeletal and connective tissue disorders
back soreness
|
5.3%
1/19 • Number of events 1
Adverse events can not be reported by intervention group because the data were not unblinded for data analyse. Based on results of preliminary analyses, the blind was not broken to further parse out the data for adverse events.
|
|
Musculoskeletal and connective tissue disorders
foot soreness
|
5.3%
1/19 • Number of events 1
Adverse events can not be reported by intervention group because the data were not unblinded for data analyse. Based on results of preliminary analyses, the blind was not broken to further parse out the data for adverse events.
|
|
Gastrointestinal disorders
nausea and vomiting
|
5.3%
1/19 • Number of events 2
Adverse events can not be reported by intervention group because the data were not unblinded for data analyse. Based on results of preliminary analyses, the blind was not broken to further parse out the data for adverse events.
|
|
General disorders
acute mountain sickness
|
5.3%
1/19 • Number of events 1
Adverse events can not be reported by intervention group because the data were not unblinded for data analyse. Based on results of preliminary analyses, the blind was not broken to further parse out the data for adverse events.
|
|
Musculoskeletal and connective tissue disorders
knee injury
|
5.3%
1/19 • Number of events 1
Adverse events can not be reported by intervention group because the data were not unblinded for data analyse. Based on results of preliminary analyses, the blind was not broken to further parse out the data for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place