- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02188511
Effects of Electronic Cigarettes on Lung Biology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aim of this study is to assess the hypothesis that electronic smoking disorders the biology of the airway epithelium and alveolar macrophages, to evaluate these changes in the lungs of normal nonsmokers exposed to electronic cigarettes, and to directly determine if the inhaled smoke from electronic cigarettes disturbs the biology of the naïve lung that has not been exposed to tobacco products. Because nicotine can be addictive with continual use, we will limit the exposure to a maximum of a nicotine equivalent of 1/2 pack of cigarettes over a 5 day period, a level that has been used safely in studies of healthy nonsmokers' naïve to nicotine.
To obtain the most unbiased data about the effect of electronic cigarette use on the lung, normal nonsmokers will be briefly exposed to electronic cigarettes and lung cells, airway epithelium and alveolar macrophages, lung epithelial lining fluid (ELF) and serum will be collected before and after e-cigarette exposure. There will be 5 study groups consisting of 10 non-smoker subjects (A-E), with each group undergoing an increased exposure to the amount of e-cigarettes (Group a being the lowest exposure, group E being the highest). Six of the subjects in each group will be exposed to e-cigarettes with nicotine while the remaining four in each group being exposed to nicotine-free e-cigarettes. Subjects will be assigned to use electronic cigarettes that either do or do not contain nicotine in a randomized, blinded manner.
The duration of which the subjects will be observed for e-cigarette exposure will be 8 days. Baselines for each group will be established on Day 1 in which all subjects will undergo a bronchoscopy and an assessment of vital signs.
For subjects in group A, at the day 8 visit after the vital signs are assessed, 3 hours prior to bronchoscopy, 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 2 hours 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. The vital signs will again be confirmed and any symptoms assessed prior to proceeding with bronchoscopy. Subjects in group B will undergo an identical exposure, but on both days 7 and 8. Subjects in group C will undergo similar exposure on days 6-8, group D on days 5-8, and group E days 4-8 for a maximum of 5 exposure days prior to bronchoscopy. The research team will contact subjects at 1 month and 6 months after their Day 8 bronchoscopy in order to determine whether or not they have become dependent on nicotine.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to meet the inclusion criteria
- Current active infection or acute illness of any kind
- Evidence of malignancy within the past 5 years
- Current alcohol or drug abuse
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Electronic cigarette (nicotine/placebo) - Day 8 Intervention: Electronic cigarette exposure will be limited to one day.
|
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 Names:
|
Experimental: Group B
Electronic cigarette (nicotine/placebo) - Days 7 through 8 Electronic cigarette exposure will be limited to two days
|
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 Names:
|
Experimental: Group C
Electronic cigarette (nicotine/placebo) - Days 6 through 8 Electronic cigarette exposure will be limited to 3 days
|
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 Names:
|
Experimental: Group D
Electronic cigarette (nicotine/placebo) - Days 5 through 8 Electronic cigarette exposure will be limited to 4 days
|
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 Names:
|
Experimental: Group E
Electronic cigarette (nicotine/placebo) - Days 4 through 8 Electronic cigarette exposure will be limited to 5 days.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Airway epithelium and aveolar macrophage
Time Frame: 8 days
|
Changes in airway epithelium and aveolar macrophage will be measured by bronchoscopy
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8 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1312014623
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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