A Phase 1 interventional study of Capsaicin vapor and fog in Parkinson's Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by University of Florida · Phase 1, Interventional, and Diagnostic
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.
The study will be completed in one visit, and take about an hour. All study procedures are done in the investigators quiet clinical research area at the Center for Movement Disorders and Neurorestoration (Room 7). If participants agree to be in this research study, after participants sign the informed consent form, the investigators will ask participants some questions related to participants health history. These questions include:
Do participants have a history of any breathing disorders or diseases (asthma, emphysema/chronic obstructive pulmonary disease (COPD), etc), or severe chest injury?
The investigators will ask these questions to make sure participants do not have a history of any illnesses that would affect their ability to cough or that would make it unsafe for them to participate. If participants answer yes to any of these questions, they will not be able to continue in the study.
Next, the investigators will begin to measure participants reflex cough. First, the investigators will attach a small microphone with a clip to participants shirt that will record participants cough responses. The investigators will have participants inhale a "hot pepper" vapor at five different concentrations. The hot pepper vapors will be separately delivered through a mouthpiece attached to a hand-held nebulizer (a device that makes vapors out of liquids). The investigators will deliver each type of vapor to participants 3 times each for a total of 15 presentations. After inhaling each vapor and coughing if participants need to, the investigators will ask participants to rate their urge to cough using a scale of 0-10, with 0 equaling no urge to cough, and 10 equaling the greatest urge to cough. If participants do not cough to any of the vapors, the investigators will present one final stronger dose. There will be a 2 minute break in between each presentation of the vapor, and water will be available at all times throughout the study. This will take approximately 40 minutes.
Next, the investigators will continue to measure participants reflex cough using a slightly different test. The investigators will have participants inhale water vapor (fog) and a low concentration of hot pepper vapor. Both types of vapor will be in separate nebulizers, like the ones the investigators just used. For these vapors, participants will breathe in and out through the nebulizer's mouthpiece until participants cough, or for up to 1 minute. The investigators will try each one 3 times, for a total of 6 tries.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 158 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
Neurological disorders other than PD (i.e., stroke, etc.)
Healthy age-matched adult participants with no history of Parkinson's disease Participants in this group will receive capsaicin vapor cough provocation test. The vapor will be delivered using a small hand-held nebulizer.
Drug: Capsaicin vapor · Device: Nebulizer
People with Parkinson's disease without penetration or aspiration during swallowing; based on results of videofluoroscopic swallow evaluation. Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer.Participants in the group will also receive a fluoroscopic swallow evaluation.
Drug: Capsaicin vapor · Other: fog · Radiation: Videofluoroscopic swallow evaluation · Device: Nebulizer
People with Parkinson's disease with penetration or aspiration during swallowing;based on results of videofluoroscopic swallow evaluation.Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer. Participants in the group will also receive a fluoroscopic swallow evaluation.
Drug: Capsaicin vapor · Other: fog · Radiation: Videofluoroscopic swallow evaluation · Device: Nebulizer
Single-breath and continuous inhalation paradigm to induce cough.
Also known as: hot pepper vapor
Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)
Also known as: aerosolized water
Fluoroscopic evaluation of oropharyngeal swallowing function.
Also known as: Swallow study, Modified barium swallow study
A hand-held nebulizer will be used to aerosolize the capsaicin and water solutions. Participants will inhale through the device's mouthpiece, and cough if they need to.
Urge-to-cough sensitivity
Slope of the line created by plotting urge-to-cough (scale of 1-11) with capsaicin concentration (5 doses of increasing intensity).
Time frame: 30 minute
Positive/negative cough response
A positive response is 2 coughs produced to 2/3 trials of the stimulus
Time frame: 10 minutes
Latency
Time from stimulus presentation to cough produced.
Time frame: 10 minutes
Cough sensitivity threshold
the lowest concentration of capsaicin that elicits a perceived urge to cough of 1 (very slight) in at least 2/3 trials
Time frame: 30 minutes
Cough motor threshold
the lowest concentration of capsaicin that elicits at least 2 cough responses in 2/3 trials
Time frame: 30 minutes
Swallowing group
The total number of participants with and without penetration or aspiration of material to the airway during swallow evaluation. Two groups will be identified, those with penetration or aspiration (PD-PA) and those without (PD).
Time frame: 20 minutes
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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