Phase 2
N=44
Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
Cough · Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02183519 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Peak Expiratory Flow Rate — 4.34; 3.92 Liters of air/second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Capsaicin (Drug); Voluntary cough test (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Expiratory Flow Rate |
4.34; 3.92 | — |
Summary
The purpose of this research study is to test cough function in individuals with Parkinson's disease and healthy older adults. Cough is a complex, defensive function which involves movement of the chest and lungs. The investigators want to compare the movement of the chest wall and the lungs during voluntary and reflex cough.
The long-term goal of this research is to develop treatments for people with cough dysfunction. Cough dysfunction increases the risk for respiratory infections such as pneumonia. The results from this study will provide information to help researchers understand the difference between reflex and voluntary cough more fully.
Eligibility Criteria
Inclusion Criteria
- Age 55-85 years
- Ability to provide informed consent
For participants with Parkinson's disease (PD):
- Diagnosis of PD (Hoehn & Yahr stages II-IV) by a University of Florida Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict United Kingdom brain bank criteria.
Exclusion Criteria
Participants with PD:
- History of neurological disorders other than PD (e.g. multiple sclerosis, stroke, brain tumor, etc)
Healthy older adults:
- History of neurological disease including PD
- History of head and neck cancer
- History of breathing disorders or disease (i.e. chronic obstructive pulmonary disease, asthma)
- History of smoking for more than 5 years at any one time (as this reduces the sensitivity to capsaicin)
- History of chest infection the last 5 weeks
- Failure of a screening test of pulmonary function (e.g. forced expiratory volume in one second/forced vital capacity<75%)
- Difficulty complying due to neuropsychological dysfunction (i.e. severe depression)
Data sourced from ClinicalTrials.gov (NCT02183519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.