ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 1348 for:    cough

Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
Drug Information available for: Capsaicin
U.S. FDA Resources

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



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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.)

Information from the National Library of Medicine

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


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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01854268     History of Changes
Other Study ID Numbers: 32-2013
First Posted: May 15, 2013    Key Record Dates
Results First Posted: March 4, 2015
Last Update Posted: October 16, 2015
Last Verified: September 2015

Keywords provided by University of Florida:
cough

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs