- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854268
Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As a participant, completion of this study will require the following:
Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Then, tests of your breathing made from pulmonary function testing will be completed.
Investigators will then have you complete a maximum inspiration followed by a maximum expiration three times.
Investigators will ask you to produce a voluntary cough three times into a facemask which is attached to a computer.
Then the investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. You will have a minute break in between each presentation.
Finally, the investigators will provide you with a nebulized dose of Capsaicin, which is derived from hot peppers, through the same facemask used in all of the above tasks. You will receive three doses of capsaicin and be provided with water at any time during the study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida, Dauer Hall
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults between the ages of 18-80 years.
- Ability to provide informed consent.
Exclusion Criteria:
- No history of smoking within the last 5 years as this reduces the sensitivity to capsaicin
- No history of neurological disease (i.e. Parkinson's disease, stroke, traumatic brain injury, etc.)
- No known allergy to capsaicin
- No history of respiratory disease (i.e. asthma, chronic obstructive pulmonary disease, or respiratory infection within the last 5 weeks.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy adults who receive capsaicin
Single treatment consisting of healthy adults.
|
Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough.
The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter.
The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask.
The participants will have a minute in between each presentation and water will be available at all times.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung Volume Initiation
Time Frame: 1 hour
|
Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Expiratory Airflow Rate
Time Frame: 1 hour
|
Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough.
Measured in liters/second.
|
1 hour
|
Urge-to-cough
Time Frame: 1 hour
|
Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra E. Brandimore, M.A., University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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