Trial Outcomes & Findings for Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease (NCT NCT02183519)
NCT ID: NCT02183519
Last Updated: 2017-03-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
44 participants
Primary outcome timeframe
1-2 hours
Results posted on
2017-03-24
Participant Flow
Parkinson's Disease = PD and Healthy Older Adult = HOA
10 PD participants did not respond to 200micro-molar capsaicin, and received the 500 micro-molar single dose. 3/10 PD participants did not respond to 500, and thus did not produce analyzable data. Due to a computer error, data was lost for 3 of the HOA participants. Complete data sets were analyzed for 13 PD and 25 HOA participants.
Participant milestones
| Measure |
Healthy Older Adults
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
Parkinson's Disease
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
16
|
|
Overall Study
COMPLETED
|
25
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Healthy Older Adults
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
Parkinson's Disease
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
|---|---|---|
|
Overall Study
computer error
|
3
|
0
|
|
Overall Study
Did not respond to cough inducter
|
0
|
3
|
Baseline Characteristics
Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Healthy Older Adults
n=25 Participants
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
Parkinson's Disease
n=13 Participants
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
13 participants
n=4 Participants
|
38 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1-2 hoursPeak 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.
Outcome measures
| Measure |
Healthy Older Adults
n=25 Participants
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
Parkinson's Disease
n=13 Participants
All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). 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 the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
|
|---|---|---|
|
Peak Expiratory Flow Rate
|
4.34 Liters of air/second
Standard Deviation .202
|
3.92 Liters of air/second
Standard Deviation .274
|
Adverse Events
Healthy Older Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parkinson's Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen Hegland, PhD
University of Florida Communicative Disorders
Phone: 352-273-3710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place