Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00753948
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2008-09-15
Brief Title:
Exhaled Levels of Nitric Oxide
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
The Effect of Nitric Oxide on Pulmonary Resistances and Blood Pressure in Persons With Tetraplegia
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Previously it was observed that individuals with tetraplegia have reduced baseline airway caliber and exhibit non-specific airway hyperresponsiveness AHR In persons with tetraplegia we have suggested that this is due to overriding cholinergic airway tone In asthma the mechanisms underlying bronchoconstriction and AHR are more closely tied to airway inflammation Whether AHR in tetraplegia is also related to chronic airway inflammation is unknown
Recently a non-invasive technique for assessing airway inflammation has been established in asthma that involves measurement of nitric oxide NO concentrations FeNO in expired air FeNO is elevated in asthma likely due to excess NO production by inflammatory cells within the airway Measurement of FeNO in persons with tetraplegia would help in assessing the role of airway inflammation in this population This may have therapeutic significance in such individuals NO in the lung is felt to be the principal inhibitory neurotransmitter of the non-adrenergic non-cholinergic NANC system It is thought that inhalation of NO has no effect on airway tone in healthy individuals but reduces methacholine responsiveness while having weak direct bronchodilatory effect in asthmatics
The primary purpose of this study is to determine the levels of exhaled NO FeNO in individuals with chronic cervical spinal cord injury SCI and to compare them with those obtained in age and sex matched able-bodied individuals and subjects with stable mild to moderate asthma If the FeNO levels are high and comparable to those found in asthmatic subjects this will imply the role of chronic inflammation in reduced baseline airway caliber and non-specific airway hyper-responsiveness AHR exhibited by individuals with chronic cervical SCI If the FeNO levels are comparable with those found in able-bodied controls this will support our previous statement that unopposed cholinergic innervation is responsible for low baseline airway caliber and AHR in individuals with chronic tetraplegia Further scientific conclusions about NO and its role in control of airway tone pulmonary resistances and blood pressure will be drawn upon intravenous and inhaled administration of L-NAME This compound has been shown promising results for the treatment and prevention of orthostatic hypotension in individuals with tetraplegia Knowing its effects on airways and potential of easier mode of delivery inhalation vs intravenous is of utmost importance
Recently a non-invasive technique for assessing airway inflammation has been established in asthma that involves measurement of nitric oxide NO concentrations FeNO in expired air FeNO is elevated in asthma likely due to excess NO production by inflammatory cells within the airway Measurement of FeNO in persons with tetraplegia would help in assessing the role of airway inflammation in this population This may have therapeutic significance in such individuals NO in the lung is felt to be the principal inhibitory neurotransmitter of the non-adrenergic non-cholinergic NANC system It is thought that inhalation of NO has no effect on airway tone in healthy individuals but reduces methacholine responsiveness while having weak direct bronchodilatory effect in asthmatics
The primary purpose of this study is to determine the levels of exhaled NO FeNO in individuals with chronic cervical spinal cord injury SCI and to compare them with those obtained in age and sex matched able-bodied individuals and subjects with stable mild to moderate asthma If the FeNO levels are high and comparable to those found in asthmatic subjects this will imply the role of chronic inflammation in reduced baseline airway caliber and non-specific airway hyper-responsiveness AHR exhibited by individuals with chronic cervical SCI If the FeNO levels are comparable with those found in able-bodied controls this will support our previous statement that unopposed cholinergic innervation is responsible for low baseline airway caliber and AHR in individuals with chronic tetraplegia Further scientific conclusions about NO and its role in control of airway tone pulmonary resistances and blood pressure will be drawn upon intravenous and inhaled administration of L-NAME This compound has been shown promising results for the treatment and prevention of orthostatic hypotension in individuals with tetraplegia Knowing its effects on airways and potential of easier mode of delivery inhalation vs intravenous is of utmost importance
Detailed Description:
The study requires a maximum of five study visits in the following order 1 nebulized normal saline 2 nebulized 1mgkg of L-NAME see below 3 intravenous normal saline 4 intravenous 1 mgkg L-NAME 5 intravenous 2 mgkg L-Name
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None