NCT02188511

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

4.5 years

First QC Date

July 2, 2014

Last Update Submit

July 22, 2020

Conditions

Lung DiseaseLung Disorder

Keywords

E-CigarettesLungNon-SmokersLung Biology

Outcome Measures

Primary Outcomes (1)

  • Airway epithelium and aveolar macrophage

    Changes in airway epithelium and aveolar macrophage will be measured by bronchoscopy

    8 days

Study Arms (5)

Group A

EXPERIMENTAL

Electronic cigarette (nicotine/placebo) - Day 8 Intervention: Electronic cigarette exposure will be limited to one day.

Other: Group A

Group B

EXPERIMENTAL

Electronic cigarette (nicotine/placebo) - Days 7 through 8 Electronic cigarette exposure will be limited to two days

Other: Group B

Group C

EXPERIMENTAL

Electronic cigarette (nicotine/placebo) - Days 6 through 8 Electronic cigarette exposure will be limited to 3 days

Other: Group C

Group D

EXPERIMENTAL

Electronic cigarette (nicotine/placebo) - Days 5 through 8 Electronic cigarette exposure will be limited to 4 days

Other: Group D

Group E

EXPERIMENTAL

Electronic cigarette (nicotine/placebo) - Days 4 through 8 Electronic cigarette exposure will be limited to 5 days.

Other: Group E

Interventions

Group AOTHER

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.

Also known as: Electronic cigarette (nicotine/placebo)- Day 8
Group A
Group BOTHER

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).

Also known as: Electronic cigarette (nicotine/placebo)- Days 7 and 8
Group B
Group COTHER

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).

Also known as: Electronic cigarette (nicotine/placebo) - Days 6 through 8
Group C
Group DOTHER

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).

Also known as: Electronic cigarette (nicotine/placebo)- Days 5 through 8
Group D
Group EOTHER

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.

Also known as: Electronic cigarette (nicotine/placebo) - Days 4 through 8
Group E

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females, age 21 or older
  • Must be capable of providing informed consent
  • Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine \<2 ng/ml and cotinine \<5 ng/ml)
  • Normal physical examination
  • Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease
  • Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
  • Not taking any medications relevant to lung disease or having an effect on the airway epithelium
  • Negative HIV serology
  • Normal chest X-ray (PA and lateral)
  • Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
  • Females - not pregnant
  • No history of allergies to medications to be used in the bronchoscopy procedure
  • Willingness to participate in the study

You may not qualify if:

  • Current active infection or acute illness of any kind
  • Evidence of malignancy within the past 5 years
  • Current alcohol or drug abuse
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (1)

  • Staudt MR, Salit J, Kaner RJ, Hollmann C, Crystal RG. Altered lung biology of healthy never smokers following acute inhalation of E-cigarettes. Respir Res. 2018 May 14;19(1):78. doi: 10.1186/s12931-018-0778-z.

    PMID: 29754582DERIVED

MeSH Terms

Conditions

Lung DiseasesVaping

Interventions

Electronic Nicotine Delivery SystemsNicotine

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSmokingBehavior

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and AgricultureSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ronald G Crystal, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 11, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

US(1)