Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

NCT01854268 | Completed Phase 1 Results DMC

• 1 other identifier: 32-2013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

cough

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (2)

• Peak Expiratory Airflow Rate

  1 hour

• Urge-to-cough

  1 hour

Study Arms (1)

Healthy adults who receive capsaicin

EXPERIMENTAL

Single treatment consisting of healthy adults.

Drug: Healthy adults who receive capsaicin

Interventions

Healthy adults who receive capsaicin DRUG

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.

Also known as: capsaicin

Healthy adults who receive capsaicin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults between the ages of 18-80 years.
• Ability to provide informed consent.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida, Dauer Hall

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Cough

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Alexandra E. Brandimore, M.A. CCC/SLP
• Organization: University of Florida

aessman@ufl.edu

352-273-3711

Study Officials

• Alexandra E. Brandimore, M.A.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 15, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 9, 2022
• Results First Posted: March 4, 2015

Record last verified: 2022-02

Locations

US (1)