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.
Brief Title
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
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.
Completion Date
Completion Date Type
Actual
Conditions
Cough
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
* 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
Inclusion Criteria
Inclusion Criteria:
* healthy adults (age18 years and above)
* nonsmokers
* healthy adults (age18 years and above)
* nonsmokers
Gender
All
Gender Based
false
Keywords
cough
cough reflex sensitivity
electronic cigarette
capsaicin
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02203162
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2014-3288
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Primary Outcomes
Outcome 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.
Outcome Measure
Change in Cough Reflex Sensitivity (Log C5)
Outcome Time Frame
Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Peter Dicpinigaitis
Investigator Email
pdicpini@montefiore.org
Investigator Phone
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
COUGH
VAPING
RESPIRATION DISORDERS
RESPIRATORY TRACT DISEASES
SIGNS AND SYMPTOMS, RESPIRATORY
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SMOKING
BEHAVIOR