Trial Outcomes & Findings for Effect of Electronic Cigarette Use on Cough Reflex Sensitivity (NCT NCT02203162)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Baseline, 15 minutes, and 24 hours post-exposure to e-cig.

Results posted on

2023-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Electronic Cigarette Exposure 30 healthy subjects-adult nonsmokers
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects n=30 Participants all subjects underwent cough challenge testing at baseline and after e-cig exposure
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	15 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Region of Enrollment United States	30 participants n=99 Participants
cough reflex sensitivity	0.5 log C5 STANDARD_DEVIATION 0.09 • n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Electronic Cigarette Exposure n=30 Participants 30 subjects-healthy adult nonsmokers
Change in Cough Reflex Sensitivity (Log C5) change after 15 min	-0.29 log C5 Interval -0.43 to -0.15
Change in Cough Reflex Sensitivity (Log C5) change after 24 hr	0.24 log C5 Interval 0.1 to 0.38

Adverse Events

Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Dicpinigaitis, MD

Montefiore Medical Center

Phone: 718-904-2676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place