Cough
Conditions
Keywords
cough, cough reflex sensitivity, electronic cigarette, capsaicin
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.
Interventions
DEVICEelectronic cigarette exposure
30 puffs of a disposable electronic cigarette, 30 seconds apart.
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cough Reflex Sensitivity (Log C5) | Baseline, 15 minutes, and 24 hours post-exposure to e-cig. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects all subjects underwent cough challenge testing at baseline and after e-cig exposure | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| cough reflex sensitivity | 0.5 log C5 STANDARD_DEVIATION 0.09 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Electronic Cigarette Exposure | Change in Cough Reflex Sensitivity (Log C5) | change after 15 min | -0.29 log C5 |
| Electronic Cigarette Exposure | Change in Cough Reflex Sensitivity (Log C5) | change after 24 hr | 0.24 log C5 |