Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183519
• Other study ID #: IRB201400477
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 2, 2014
• Last updated: September 15, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

If the participant agrees to participate, the investigators will first test pulmonary (lung) function. Next, the investigators will test voluntary and reflex cough. After this first round of cough testing, the investigators will ask participants to cough long and hard during voluntary and reflex cough testing. Finally, the investigators will view the larynx (voice box) with an endoscopic camera inserted through the nose. This test is done to see if there are any changes in the larynx that may influence cough.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Capsaicin
For reflex cough testing, all participants will receive various concentrations of nebulized capsaicin. Delivery of multiple concentrations and doses of capsaicin allows for accurate assessment of reflex cough sensitivity.

Other:
• Healthy Older Adults
For this study all participants will receive reflex and voluntary cough testing. This will include coughing on command and reflex cough sensitivity testing. Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand reflex and voluntary cough more fully.
• Parkinson's Disease
For this study all participants will receive reflex and voluntary cough testing. This will include coughing on command and reflex cough sensitivity testing. Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand reflex and voluntary cough more fully.

Locations

Country	Name	City	State
United States	Center for Movement Disorders and Neurorestoration	Gainesville	Florida
United States	Dauer Hall, University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith JA, Aliverti A, Quaranta M, McGuinness K, Kelsall A, Earis J, Calverley PM. Chest wall dynamics during voluntary and induced cough in healthy volunteers. J Physiol. 2012 Feb 1;590(3):563-74. doi: 10.1113/jphysiol.2011.213157. Epub 2011 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung volume initiation	Lung volume initiation is the volume of air in the lungs prior to production of the expiratory phase of cough.	1-2 hours	No
Primary	Peak expiratory flow rate	Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.	1-2 hours	No