Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

• ClinicalTrials.gov Identifier: NCT02203162
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: May 4, 2016
• Last Update Posted: June 4, 2018
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Peter Dicpinigaitis, Montefiore Medical Center

Tracking Information

• First Submitted Date: July 25, 2014
• First Posted Date: July 29, 2014
• Results First Submitted Date: January 22, 2016
• Results First Posted Date: May 4, 2016
• Last Update Posted Date: June 4, 2018
• Study Start Date: July 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 24, 2016)

Change in Cough Reflex Sensitivity (Log C5) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: July 25, 2014)

Cough reflex sensitivity [ Time Frame: 15 minutes ]

Measurement of cough reflex sensitivity to capsaicin performed 15 minutes after electronic cigarette use session

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
• Official Title: Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Cough

Intervention

Device: electronic cigarette exposure

30 puffs of a disposable electronic cigarette, 30 seconds apart.

Study Arms

Experimental: cough reflex sensitivity

electronic cigarette exposure

Intervention: Device: electronic cigarette exposure

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 25, 2014): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02203162
• Other Study ID Numbers: MMC-IRB-2014-3288
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Results of this study have been published in January 2016 as a full manuscript.

• Responsible Party: Peter Dicpinigaitis, Montefiore Medical Center
• Study Sponsor: Montefiore Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Peter V Dicpinigaitis, MD; Montefiore Medical Center and Albert Einstein College of Medicine

• PRS Account: Montefiore Medical Center
• Verification Date: May 2018