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Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

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ClinicalTrials.gov Identifier: NCT02203162
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : May 4, 2016
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Dicpinigaitis, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Cough
Intervention Device: electronic cigarette exposure
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Electronic Cigarette Exposure
Hide Arm/Group Description 30 healthy subjects-adult nonsmokers
Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Subjects
Hide Arm/Group Description all subjects underwent cough challenge testing at baseline and after e-cig exposure
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
adult nonsmokers
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
cough reflex sensitivity  
Mean (Standard Deviation)
Unit of measure:  Log C5
Number Analyzed 30 participants
0.5  (0.09)
1.Primary Outcome
Title Change in Cough Reflex Sensitivity (Log C5)
Hide Description Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
Time Frame Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electronic Cigarette Exposure
Hide Arm/Group Description:
30 subjects-healthy adult nonsmokers
Overall Number of Participants Analyzed 30
Mean (95% Confidence Interval)
Unit of Measure: log C5
change after 15 min
-0.29
(-0.43 to -0.15)
change after 24 hr
0.24
(0.10 to 0.38)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects
Hide Arm/Group Description 30 subjects-adult nonsmokers
All-Cause Mortality
Subjects
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Subjects
Affected / at Risk (%)
Total   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Dicpinigaitis, MD
Organization: Montefiore Medical Center
Phone: 718-904-2676
EMail: pdicpini@montefiore.org
Layout table for additonal information
Responsible Party: Peter Dicpinigaitis, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02203162    
Other Study ID Numbers: MMC-IRB-2014-3288
First Submitted: July 25, 2014
First Posted: July 29, 2014
Results First Submitted: January 22, 2016
Results First Posted: May 4, 2016
Last Update Posted: June 4, 2018