Working… Menu

Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02203162
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : May 4, 2016
Last Update Posted : June 4, 2018
Information provided by (Responsible Party):
Peter Dicpinigaitis, 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.

Condition or disease Intervention/treatment Phase
Cough Device: electronic cigarette exposure Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: cough reflex sensitivity
electronic cigarette exposure
Device: electronic cigarette exposure
30 puffs of a disposable electronic cigarette, 30 seconds apart.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02203162

Layout table for location information
United States, New York
Einstein Division/Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Layout table for investigator information
Principal Investigator: Peter V Dicpinigaitis, MD Montefiore Medical Center and Albert Einstein College of Medicine
Publications of Results:
Layout table for additonal information
Responsible Party: Peter Dicpinigaitis, Prof. Dept of Medicine (Critical Care), Montefiore Medical Center Identifier: NCT02203162    
Other Study ID Numbers: MMC-IRB-2014-3288
First Posted: July 29, 2014    Key Record Dates
Results First Posted: May 4, 2016
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results of this study have been published in January 2016 as a full manuscript.
Keywords provided by Peter Dicpinigaitis, Montefiore Medical Center:
cough reflex sensitivity
electronic cigarette
Additional relevant MeSH terms:
Layout table for MeSH terms
Immune System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory