Trial Outcomes & Findings for Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults (NCT NCT01854268)

NCT ID: NCT01854268

Last Updated: 2022-02-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	Healthy Adults Who Receive Capsaicin 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.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

Baseline characteristics by cohort

Measure	Healthy Adults Who Receive Capsaicin n=25 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.3 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Lung volume initiation	23.3 %vital capacity, relative to EEL STANDARD_DEVIATION 5.8 • n=5 Participants
Peak expiratory airflow rate	6.058 Liters/second STANDARD_DEVIATION .56 • n=5 Participants
Urge-to-cough	7 units on a scale STANDARD_DEVIATION .32 • n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.

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.

Outcome measures

Measure

Healthy Adults Who Receive Capsaicin n=25 Participants 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.

Lung Volume Initiation

23.3 % Vital Capacity, relative to EEL Standard Deviation 5.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Adults Who Receive Capsaicin n=25 Participants 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.
Peak Expiratory Airflow Rate PEFR - Voluntary Cough	6.058 Liters/second Standard Deviation .56
Peak Expiratory Airflow Rate PEFR - Reflex Cough	5.437 Liters/second Standard Deviation .43

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Healthy Adults Who Receive Capsaicin n=25 Participants 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.

Urge-to-cough

6 units on a scale Standard Error .4

Adverse Events

Healthy Adults Who Receive Capsaicin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexandra E. Brandimore, M.A. CCC/SLP

University of Florida

Phone: 352-273-3711

Email: aessman@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place