Effects of Electronic Cigarettes on Lung Biology

Summary

E-cigarettes are an increasingly popular alternate nicotine delivery system, but nothing is known about the effects of electronic cigarettes on the lungs. We hypothesize that e-cigarettes disorder airway epithelial and alveolar macrophages biology. Our goal is not to carry out a large epidemiologic study of electronic cigarette users to study lung function and other possible abnormal clinical phenotypes, but rather to focus on whether electronic cigarette smoke disorders the biology of the lung cells first exposed to the electronic cigarette smoke, a parameter that is the precursor of abnormalities in lung function and which is far more sensitive than lung function.

Conditions

• Lung Disease
• Lung Disorder

Interventions

OTHER

Group A

90 minutes prior to the bronchoscopy on day 8, the subject will be asked to inhale 10 puffs of a Blu brand e-cigarette (for the nicotine-containing e-cigarette, this is approximately equivalent to \< 1 cigarette). At 30 minutes prior to the bronchoscopy procedure if the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette.

OTHER

Group B

On days 7 and 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).

OTHER

Group C

On days 6 through 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).

OTHER

Group D

On days 5 through 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).

OTHER

Group E

On days 4 through 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8). Exposure to e-cigarettes will be limited to the nicotine equivalent of 1/2 pack of cigarettes to mitigate the risk of addiction to nicotine.

Sponsors & Collaborators

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Ronald G Crystal, MD · Weill Medical College of Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2018-07-31

Completion

2018-07-31

Countries

• United States

Study Locations