Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Conditions
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Cough

Intervention / Treatment
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* Device: electronic cigarette exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cough reflex sensitivity<br>electronic cigarette exposure | Device: electronic cigarette exposure<br>* 30 puffs of a disposable electronic cigarette, 30 seconds apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 15 minutes, and 24 hours post-exposure to e-cig. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cough, cough reflex sensitivity, electronic cigarette, capsaicin