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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
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cough
Intervention Drug: Healthy adults who receive capsaicin
Enrollment 25

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Adults Who Receive Capsaicin
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Single treatment consisting of healthy adults.

Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.

Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.

Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation.

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Healthy Adults Who Receive Capsaicin
Hide Arm/Group Description

Single treatment consisting of healthy adults.

Healthy adults who receive capsaicin: Participants were 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 breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.

Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.

Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation.

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
All participants were evaluated one time. Therefore baseline evaluations were the only measures completed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
23.3  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Lung volume initiation  
Mean (Standard Deviation)
Unit of measure:  %vital capacity, relative to EEL
Number Analyzed 25 participants
23.3  (5.8)
Peak expiratory airflow rate  
Mean (Standard Deviation)
Unit of measure:  Liters/second
Number Analyzed 25 participants
6.058  (.56)
Urge-to-cough  
Median (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
7  (.32)
1.Primary Outcome
Title Lung Volume Initiation
Hide 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
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Hide Analysis Population Description
25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.
Arm/Group Title Healthy Adults Who Receive Capsaicin
Hide Arm/Group Description:

Single treatment consisting of healthy adults.

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.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % Vital Capacity, relative to EEL
23.3  (5.7)
2.Secondary Outcome
Title Peak Expiratory Airflow Rate
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Adults Who Receive Capsaicin
Hide Arm/Group Description:

Single treatment consisting of healthy adults.

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.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Liters/second
PEFR - Voluntary Cough 6.058  (.56)
PEFR - Reflex Cough 5.437  (.43)
3.Secondary Outcome
Title Urge-to-cough
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Adults Who Receive Capsaicin
Hide Arm/Group Description:

Single treatment consisting of healthy adults.

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.

Overall Number of Participants Analyzed 25
Median (Standard Error)
Unit of Measure: units on a scale
6  (.4)
Time Frame All study participants were recruited during one month.
Adverse Event Reporting Description There were no adverse events associated with this protocol.
 
Arm/Group Title Healthy Adults Who Receive Capsaicin
Hide Arm/Group Description

Single treatment consisting of healthy adults.

Healthy adults received capsaicin: Participants were 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 breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times.

All-Cause Mortality
Healthy Adults Who Receive Capsaicin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Adults Who Receive Capsaicin
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Adults Who Receive Capsaicin
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alexandra E. Brandimore, M.A. CCC/SLP
Organization: University of Florida
Phone: 352-273-3711
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01854268     History of Changes
Other Study ID Numbers: 32-2013
First Submitted: May 10, 2013
First Posted: May 15, 2013
Results First Submitted: December 10, 2014
Results First Posted: March 4, 2015
Last Update Posted: October 16, 2015