Back to resultsEffect of Electronic Cigarette Use on Cough Reflex Sensitivity
Primary Purpose
Cough
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
electronic cigarette exposure
Sponsored by
About this trial
This is an interventional other trial for Cough focused on measuring cough, cough reflex sensitivity, electronic cigarette, capsaicin
Eligibility Criteria
Inclusion Criteria:
- healthy adults (age18 years and above)
- nonsmokers
Exclusion Criteria:
- previous smoker
- asthma/other respiratory illness
- acute viral upper respiratory tract infection (common cold) in previous 4 weeks
Sites / Locations
- Einstein Division/Montefiore Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cough reflex sensitivity
Arm Description
electronic cigarette exposure
Outcomes
Primary Outcome Measures
Change in Cough Reflex Sensitivity (Log C5)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02203162
Brief Title
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Official Title
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although electronic cigarettes (e-cigs) are now widely used, very little information exists regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30 seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.
Detailed Description
30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5, the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough challenge studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
cough, cough reflex sensitivity, electronic cigarette, capsaicin
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cough reflex sensitivity
Arm Type
Experimental
Arm Description
electronic cigarette exposure
Intervention Type
Device
Intervention Name(s)
electronic cigarette exposure
Intervention Description
30 puffs of a disposable electronic cigarette, 30 seconds apart.
Primary Outcome Measure Information:
Title
Change in Cough Reflex Sensitivity (Log C5)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy adults (age18 years and above)
nonsmokers
Exclusion Criteria:
previous smoker
asthma/other respiratory illness
acute viral upper respiratory tract infection (common cold) in previous 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter V Dicpinigaitis, MD
Organizational Affiliation
Montefiore Medical Center and Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Einstein Division/Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Results of this study have been published in January 2016 as a full manuscript.
Citations:
PubMed Identifier
26291648
Citation
Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.
Results Reference
result
Learn more about this trial
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
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