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NCT02390089 · ClinicalTrials.gov registry record · Phase 1
Cough According to Stimulus Type in PD
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
NCT02390089: Completed Phase 1 study, sponsored by University of Florida.
NCT02390089 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 158 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02390089, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
Study Summary
Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD) versus healthy adults. This is of particular public health concern given that death secondary to aspiration pneumonia and lung infection is a leading cause of death in persons with PD. Swallowing and cough function are affected in PD, putting people with PD at significant risk for uncompensated aspiration (aspiration without adequate cough response). One challenge in the management of airway protective deficits related to PD is the chronic and progressive nature of the disease, where swallowing dysfunction appears subtly in the form of microaspiration, reducing the perceived urgency of the swallowing disorder by both clinicians and patients. The long-term goal of this research is to advance the management of airway protection deficits in patients with neurodegenerative disease in order to decrease morbidity and mortality due to aspiration related lung infection. The objective here is to further specify deficits leading to uncompensated airway compromise in PD in order to advance the clinical management of these patients, leading to an immediate positive impact.
Primary Outcome
Slope of the line created by plotting urge-to-cough (scale of 1-11) with capsaicin concentration (5 doses of increasing intensity).
Interventions
- DRUG Capsaicin vapor
- OTHER fog
- RADIATION Videofluoroscopic swallow evaluation
- DEVICE Nebulizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-02-13 |
| Phase | Phase 1 |
What the finished NCT02390089 record still lists
NCT02390089 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher).
The record links to 0 conditions, and to 4 interventions - of which Capsaicin vapor is the first listed.
NCT02390089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02390089 about?
NCT02390089 is a clinical study titled "Cough According to Stimulus Type in PD". Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD) versus healthy adults. This is of particular public health concern given that death secondary to aspiration pneumonia and lung infection is a leading cause of death in persons with PD. Swallowing and cough f...
What is the current status of trial NCT02390089?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2015-04. Estimated completion is 2019-02-13.
What interventions are being tested in trial NCT02390089?
The interventions under investigation include: Capsaicin vapor (DRUG), fog (OTHER), Videofluoroscopic swallow evaluation (RADIATION), Nebulizer (DEVICE).
Who is sponsoring clinical trial NCT02390089?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02390089's enrollment target sits among peer trials
158 348th of 2000 higher than 1,650 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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