Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT01854268|
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : March 4, 2015
Last Update Posted : October 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cough||Drug: Healthy adults who receive capsaicin||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Healthy adults who receive capsaicin
Single treatment consisting of healthy adults.
Drug: Healthy adults who receive capsaicin
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 Name: capsaicin
- 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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854268
|United States, Florida|
|University of Florida, Dauer Hall|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Alexandra E. Brandimore, M.A.||University of Florida|