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NCT02586649 · ClinicalTrials.gov registry record · Phase 2
24hr Effects of Tiotropium Bromide in Tetraplegia
A Phase 2 study of Spinal Cord Injury, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02586649 is a Phase 2 study of Spinal Cord Injury that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 10 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02586649, a Phase 2 study of Spinal Cord Injury, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Respiratory complications are the leading cause of death during the initial year after acute SCI, and the third leading cause of death thereafter. Complete or partial loss of respiratory muscle innervations in individuals with cervical and high thoracic injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelactasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. It is well known that a restrictive ventilatory defect, dependent upon the level and completeness of injury, is apparent in individuals with chronic cervical SCI. Respiratory functional impairment might be further compromised in these individuals, the majority of whom share many aspects of obstructive airway physiology commonly associated with asthma. The asthma-like features that individuals with chronic cervical SCI demonstrate have been hypothesized to be due to overriding cholinergic airway tone carried by intact vagal (parasympathetic) nerve fibers arising from the brainstem, whereas sympathetic innervations is interrupted at the level of the upper thoracic spinal cord. Whether airway narrowing and AHR in chronic cervical SCI is also related to chronic airway inflammation is unknown, although it is conceivable that repeated respiratory infections or, possibly, a neurogenic component, could contribute to chronic airway inflammation. Therefore, the investigators aim to assess how long-acting bronchodilator (tiotropium bromide) affects various indices of lung function, including: pulmonary function tests, levels of inflammation and cough strength across 24 hours after receiving study drug. Results will be analyzed for baseline, 1 hour, 3 hours, 20 hours and 24 hours post drug inhalation for both active medication and non-active placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tiotropium Bromide
Study Locations (1)
New York
- James J Peters VA Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-07 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02586649
The ClinicalTrials.gov registry entry for NCT02586649 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (88% lower). The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02586649 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02586649 about?
NCT02586649 is a clinical study titled "24hr Effects of Tiotropium Bromide in Tetraplegia". Respiratory complications are the leading cause of death during the initial year after acute SCI, and the third leading cause of death thereafter. Complete or partial loss of respiratory muscle innervations in individuals with cervical and high thoracic injuries leads to inadequate ventilation and i...
What is the current status of trial NCT02586649?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2014-07. Estimated completion is 2019-12.
What conditions does trial NCT02586649 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT02586649?
The interventions under investigation include: Placebo (DRUG), Tiotropium Bromide (DRUG).
Who is sponsoring clinical trial NCT02586649?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02586649 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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