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Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

Primary Purpose

Cough

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Healthy adults who receive capsaicin
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cough focused on measuring cough

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • University of Florida, Dauer Hall

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy adults who receive capsaicin

Arm Description

Single treatment consisting of healthy adults.

Outcomes

Primary Outcome Measures

Lung Volume Initiation
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.

Secondary Outcome Measures

Peak Expiratory Airflow Rate
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
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).

Full Information

First Posted
May 10, 2013
Last Updated
February 3, 2022
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01854268
Brief Title
Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
Official Title
Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cough is a defensive behavior that involves three stages. A large inspiratory phase, a compression phase where the vocal folds close and subglottal pressure is developed, and an expiratory phase. Cough serves to protect the upper and lower airways from material such as liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that is generated secondary to a stimulus in or near the airway. There has been some research regarding the differences between voluntary and reflex cough. However, no research has described the differences in airflow or movement pattern (kinematics) between the two types of cough. This study seeks to determine the respiratory kinematics and airflow differences between voluntary and reflex cough in healthy participants.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
cough

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy adults who receive capsaicin
Arm Type
Experimental
Arm Description
Single treatment consisting of healthy adults.
Intervention Type
Drug
Intervention Name(s)
Healthy adults who receive capsaicin
Other Intervention Name(s)
capsaicin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung Volume Initiation
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Peak Expiratory Airflow Rate
Description
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.
Time Frame
1 hour
Title
Urge-to-cough
Description
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).
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra E. Brandimore, M.A.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Dauer Hall
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

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Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

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