Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
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:
Information provided by (Responsible Party):
Peter Dicpinigaitis, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE July 25, 2014
First Posted Date  ICMJE July 29, 2014
Results First Submitted Date  ICMJE January 22, 2016
Results First Posted Date  ICMJE May 4, 2016
Last Update Posted Date June 4, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cough
Intervention  ICMJE Device: electronic cigarette exposure
30 puffs of a disposable electronic cigarette, 30 seconds apart.
Study Arms  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203162
Other Study ID Numbers  ICMJE MMC-IRB-2014-3288
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter V Dicpinigaitis, MD Montefiore Medical Center and Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP