Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

NCT02203162 | Completed Phase 4 Results

• 1 other identifier: 2014-3288
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

cough; cough reflex sensitivity; electronic cigarette; capsaicin

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

cough reflex sensitivity

EXPERIMENTAL

electronic cigarette exposure

Device: electronic cigarette exposure

Interventions

electronic cigarette exposure DEVICE

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

cough reflex sensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults (age18 years and above)
• nonsmokers

You may not qualify if:

• previous smoker
• asthma/other respiratory illness
• acute viral upper respiratory tract infection (common cold) in previous 4 weeks

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Einstein Division/Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related 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.

  PMID: 26291648 RESULT

MeSH Terms

Conditions

Cough; Vaping

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Smoking; Behavior

Results Point of Contact

• Title: Peter Dicpinigaitis, MD
• Organization: Montefiore Medical Center

pdicpini@montefiore.org

718-904-2676

Study Officials

• Peter V Dicpinigaitis, MD

  Montefiore Medical Center and Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 28, 2023
• Results First Posted: May 4, 2016

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)