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Trial record 3 of 5 for:    "Quadriplegia" | "Bronchodilator Agents"

Exhaled Levels of Nitric Oxide

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ClinicalTrials.gov Identifier: NCT00753948
Recruitment Status : Completed
First Posted : September 17, 2008
Results First Posted : July 4, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions Tetraplegia
Asthma
Intervention Drug: N-Nitro L-arginine-methylester (L-NAME)
Enrollment 23
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Chronic Tetraplegia Mild Asthma Healthy Control
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Individuals with chronic tetraplegia

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Individuals with diagnosed mild asthma

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Neurologically intact, otherwise healthy, age-matched control

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Period Title: Overall Study
Started 9 7 7
Completed 9 7 7
Not Completed 0 0 0
Arm/Group Title Chronic Tetraplegia Mild Asthma Healthy Controls Total
Hide Arm/Group Description

Individuals with chronic tetraplegia

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Individuals with diagnosed mild asthma

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

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 of all reporting groups
Overall Number of Baseline Participants 9 7 7 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 7 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
7
 100.0%
7
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 7 participants 7 participants 23 participants
42  (10) 42  (9) 37  (10) 40  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 7 participants 23 participants
Female
1
  11.1%
1
  14.3%
1
  14.3%
3
  13.0%
Male
8
  88.9%
6
  85.7%
6
  85.7%
20
  87.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 7 participants 7 participants 23 participants
9 7 7 23
1.Primary Outcome
Title Exhaled Levels of Nitric Oxide
Hide Description 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
Time Frame Exhaled NO was reported as the mean of three values within 10% of each other.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:

Individuals with chronic tetraplegia

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Individuals with diagnosed mild asthma

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

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 Number of Participants Analyzed 9 7 7
Mean (Standard Deviation)
Unit of Measure: ppb (parts per bilion)
17.72  (3.9) 20.23  (4.64) 10.37  (4.9)
2.Secondary Outcome
Title Lung Function as Measured by Plethysmography
Hide Description [Not Specified]
Time Frame During study visits, measures are obtained prior to intervention (intravenous or nebulized) and 60, 120 minutes post intervention.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Methacholine Challenge
Hide Description [Not Specified]
Time Frame During study visits, methacholine challenge will be performed 120 minutes post intervention.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description

Individuals with chronic tetraplegia

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Individuals with diagnosed mild asthma

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

Neurologically intact, otherwise healthy, age-matched control

N-Nitro L-arginine-methylester (L-NAME) : A non-specific inhibitor of the nitric oxide synthase enzyme.

All-Cause Mortality
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/7 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joshua Hobson
Organization: James J. Peters VAMC
Phone: (718) 584-9000 ext 3129
EMail: joshua.hobson@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00753948     History of Changes
Other Study ID Numbers: B4335-V
First Submitted: September 15, 2008
First Posted: September 17, 2008
Results First Submitted: September 27, 2013
Results First Posted: July 4, 2014
Last Update Posted: July 4, 2014