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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cough reflex sensitivity | Experimental | electronic cigarette exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic cigarette exposure | Device | 30 puffs of a disposable electronic cigarette, 30 seconds apart. |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter V Dicpinigaitis, MD | Montefiore Medical Center and Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Einstein Division/Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26291648 | Result | 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. |
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Results of this study have been published in January 2016 as a full manuscript.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electronic Cigarette Exposure | 30 healthy subjects-adult nonsmokers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
adult nonsmokers
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects | all subjects underwent cough challenge testing at baseline and after e-cig exposure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | log C5 | Baseline, 15 minutes, and 24 hours post-exposure to e-cig. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects | 30 subjects-adult nonsmokers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Dicpinigaitis, MD | Montefiore Medical Center | 718-904-2676 | pdicpini@montefiore.org |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| cough reflex sensitivity | Mean | Standard Deviation | log C5 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D012907 | Smoking |
| D001519 | Behavior |