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Trial record 26 of 1350 for:    cough

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Healthy Adults Who Receive Capsaicin
STARTED   25 
COMPLETED   25 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants were evaluated one time. Therefore baseline evaluations were the only measures completed.

Reporting Groups
  Description
Healthy Adults Who Receive Capsaicin

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.


Baseline Measures
   Healthy Adults Who Receive Capsaicin 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.3  (3.3) 
Gender 
[Units: Participants]
 
Female   14 
Male   11 
Region of Enrollment 
[Units: Participants]
 
United States   25 
Lung volume initiation 
[Units: %vital capacity, relative to EEL]
Mean (Standard Deviation)
 23.3  (5.8) 
Peak expiratory airflow rate 
[Units: Liters/second]
Mean (Standard Deviation)
 6.058  (.56) 
Urge-to-cough 
[Units: Units on a scale]
Median (Standard Deviation)
 7  (.32) 


  Outcome Measures

1.  Primary:   Lung Volume Initiation   [ Time Frame: 1 hour ]

2.  Secondary:   Peak Expiratory Airflow Rate   [ Time Frame: 1 hour ]

3.  Secondary:   Urge-to-cough   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: aessman@ufl.edu



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