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Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

NCT ID: NCT02203162

Last Updated: 2023-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cough

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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cough reflex sensitivity

electronic cigarette exposure

Group Type EXPERIMENTAL

electronic cigarette exposure

Intervention Type DEVICE

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

Interventions

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electronic cigarette exposure

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter V Dicpinigaitis, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center and Albert Einstein College of Medicine

Locations

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Einstein Division/Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26291648 (View on PubMed)

Other Identifiers

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2014-3288

Identifier Type: -

Identifier Source: org_study_id

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