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Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

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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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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 ClinicalTrials.gov identifier (NCT number): NCT02203162


Locations
United States, New York
Einstein Division/Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Peter V Dicpinigaitis, MD Montefiore Medical Center and Albert Einstein College of Medicine

Publications of Results:
Responsible Party: Peter Dicpinigaitis, Prof. Dept of Medicine (Critical Care), Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02203162     History of Changes
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
cough reflex sensitivity
electronic cigarette
capsaicin

Additional relevant MeSH terms:
Hypersensitivity
Cough
Immune System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms