Trial Outcomes & Findings for Exhaled Levels of Nitric Oxide (NCT NCT00753948)

Results Overview

Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress. Exhaled NO was reported as the mean of three values within 10% of each other.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

23 participants

Primary outcome timeframe

Exhaled NO reported during visit, before intervention at baseline, post intervention at 60 minutes and 120 minutes

Results posted on

2020-02-28

Participant Flow

Participants were recruited from SCI service of James J. Peters VAMC as well as from SCI outpatient clinics. Participants in the asthma group were recruited through medicine clinic at James J. Peters VAMC. Healthy able-bodied controls were recruited from the group of able-bodied controls that has been doing studies with our center in the past.

Participant milestones

Participant milestones
Measure	Chronic Tetraplegia Individuals with chronic tetraplegia N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Mild Asthma Individuals with diagnosed mild asthma N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Healthy Control Neurologically intact, otherwise healthy, age-matched control N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.
Overall Study STARTED	9	7	7
Overall Study COMPLETED	9	7	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exhaled Levels of Nitric Oxide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Tetraplegia n=9 Participants Individuals with chronic tetraplegia N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Mild Asthma n=7 Participants Individuals with diagnosed mild asthma N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Healthy Controls n=7 Participants Neurologically intact, otherwise healthy, age-matched control N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	42 years STANDARD_DEVIATION 10 • n=5 Participants	42 years STANDARD_DEVIATION 9 • n=7 Participants	37 years STANDARD_DEVIATION 10 • n=5 Participants	40 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment United States	9 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants

PRIMARY outcome

Timeframe: Exhaled NO reported during visit, before intervention at baseline, post intervention at 60 minutes and 120 minutes

Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress. Exhaled NO was reported as the mean of three values within 10% of each other.

Outcome measures

Outcome measures
Measure	Chronic Tetraplegia n=7 Participants Individuals with chronic tetraplegia N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Mild Asthma n=3 Participants Individuals with diagnosed mild asthma N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Healthy Controls n=7 Participants Neurologically intact, otherwise healthy, age-matched control N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.
Exhaled Levels of Nitric Oxide Baseline (before intervention)	17.27 ppb (parts per bilion) Standard Deviation 4.96	19.83 ppb (parts per bilion) Standard Deviation 8.15	15.025 ppb (parts per bilion) Standard Deviation 9.75
Exhaled Levels of Nitric Oxide 60 minutes (post intervention)	3.70 ppb (parts per bilion) Standard Deviation 3.14	5.56 ppb (parts per bilion) Standard Deviation 2.93	4.07 ppb (parts per bilion) Standard Deviation 3.47
Exhaled Levels of Nitric Oxide 120 minutes (post intervention)	3.04 ppb (parts per bilion) Standard Deviation 2.23	5.73 ppb (parts per bilion) Standard Deviation 3.70	3.71 ppb (parts per bilion) Standard Deviation 3.46

SECONDARY outcome

Timeframe: Specific airway conductance reported during visit, before intervention at baseline, post intervention at 60 minutes and 120 minutes

Specific airway conductance (sGaw) is the airway conductance relative to lung volume because it takes into account the important effect of lung volume on airway resistance, it is a useful index of bronchomotor tone.

Outcome measures

Outcome measures
Measure	Chronic Tetraplegia n=7 Participants Individuals with chronic tetraplegia N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Mild Asthma n=1 Participants Individuals with diagnosed mild asthma N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.	Healthy Controls n=7 Participants Neurologically intact, otherwise healthy, age-matched control N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.
Specific Airway Conductance (sGaw) as Measured by Plethysmography Baseline (before intervention)	0.164 L/sec/cmH20/L Standard Deviation 0.071	0.336 L/sec/cmH20/L Standard Deviation 0	0.197 L/sec/cmH20/L Standard Deviation 0.043
Specific Airway Conductance (sGaw) as Measured by Plethysmography 60 minutes (post intervention)	0.218 L/sec/cmH20/L Standard Deviation 0.093	0.315 L/sec/cmH20/L Standard Deviation 0	0.196 L/sec/cmH20/L Standard Deviation 0.047
Specific Airway Conductance (sGaw) as Measured by Plethysmography 120 minutes (post intervention)	0.207 L/sec/cmH20/L Standard Deviation 0.094	0.345 L/sec/cmH20/L Standard Deviation 0	0.197 L/sec/cmH20/L Standard Deviation 0.043

Adverse Events

Chronic Tetraplegia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joshua Hobson

James J. Peters VAMC

Phone: (718) 584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place