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NCT00753948 · ClinicalTrials.gov registry record · Phase 2
Exhaled Levels of Nitric Oxide
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT00753948: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT00753948 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00753948, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study 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 an
Interventions
- DRUG N-Nitro L-arginine-methylester (L-NAME)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00753948
The ClinicalTrials.gov registry entry for NCT00753948 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N-Nitro L-arginine-methylester (L-NAME) is the first listed.
NCT00753948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00753948 about?
NCT00753948 is a clinical study titled "Exhaled Levels of Nitric Oxide". 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 bron...
What is the current status of trial NCT00753948?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2006-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00753948?
The interventions under investigation include: N-Nitro L-arginine-methylester (L-NAME) (DRUG).
Who is sponsoring clinical trial NCT00753948?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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