Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Phase 4

Completed

• Conditions: Cough
• Interventions: Device: electronic cigarette exposure

• Registration Number: NCT02203162
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-01-22
• Results First Submitted QC: 2016-04-01
• Results First Posted: 2016-05-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cough reflex sensitivity	electronic cigarette exposure	electronic cigarette exposure

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Einstein Division/Montefiore Medical Center; 🇺🇸 Bronx, New York, United States