Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Cough Clinical Trial

Official title:

Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203162
• Other study ID #: 2014-3288
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Hypersensitivity

Intervention

Device:
• electronic cigarette exposure
30 puffs of a disposable electronic cigarette, 30 seconds apart.

Locations

Country	Name	City	State
United States	Einstein Division/Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 15 minutes, and 24 hours post-exposure to e-cig.