Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

• ClinicalTrials.gov Identifier: NCT01854268
• Recruitment Status: Completed
• First Posted: May 15, 2013
• Results First Posted: March 4, 2015
• Last Update Posted: February 9, 2022
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

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.

Condition or disease	Intervention/treatment	Phase
Cough	Drug: Healthy adults who receive capsaicin	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.)

Contacts and Locations

Locations

United States, Florida

University of Florida, Dauer Hall

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Alexandra E. Brandimore, M.A.; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01854268
• Other Study ID Numbers: 32-2013
• First Posted: May 15, 2013
• Results First Posted: March 4, 2015
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Keywords provided by University of Florida:

cough

Additional relevant MeSH terms:

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Capsaicin; Antipruritics; Dermatologic Agents; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs