Lung DiseaseNCT02188511
Effects of Electronic Cigarettes on Lung Biology
A study testing Group A, Group B and Group C in people with Lung Disease and Lung Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Disease, Lung Disorder
- What is being tested?
- Group A, Group B and Group C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Lung Disease, Lung Disorder
- Being tested
- Group A, Group B, Group C, Group D, Group E
- Keywords
- E-Cigarettes, Lung, Non-Smokers, Lung Biology
- Medical subject headings
- Lung Diseases, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called Electronic cigarette (nicotine/placebo)- Day 8
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.
Group BOther
Also called Electronic cigarette (nicotine/placebo)- Days 7 and 8
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).
Group COther
Also called Electronic cigarette (nicotine/placebo) - Days 6 through 8
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).
Group DOther
Also called Electronic cigarette (nicotine/placebo)- Days 5 through 8
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).
Group EOther
Also called Electronic cigarette (nicotine/placebo) - Days 4 through 8
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Electronic cigarette (nicotine/placebo) - Day 8 Intervention: Electronic cigarette exposure will be limited to one day. Receives: Other: Group A |
| Group B | Experimental | Electronic cigarette (nicotine/placebo) - Days 7 through 8 Electronic cigarette exposure will be limited to two days Receives: Other: Group B |
| Group C | Experimental | Electronic cigarette (nicotine/placebo) - Days 6 through 8 Electronic cigarette exposure will be limited to 3 days Receives: Other: Group C |
| Group D | Experimental | Electronic cigarette (nicotine/placebo) - Days 5 through 8 Electronic cigarette exposure will be limited to 4 days Receives: Other: Group D |
| Group E | Experimental | Electronic cigarette (nicotine/placebo) - Days 4 through 8 Electronic cigarette exposure will be limited to 5 days. Receives: Other: Group E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway epithelium and aveolar macrophage
Changes in airway epithelium and aveolar macrophage will be measured by bronchoscopy
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188511
- Sponsor's protocol ID
- 1312014623
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2014
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29754582
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electronic Cigarettes on Lung Biology
- ClinicalTrials.gov ID
- NCT02188511
- Acronym / sponsor ID
- 1312014623
- Conditions
- Lung Disease, Lung Disorder
- Keywords
- E-Cigarettes, Lung, Non-Smokers, Lung Biology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Group AElectronic cigarette (nicotine/placebo) - Day 8 Intervention: Electronic cigarette exposure will be limited to one day. |
| Group B | Experimental | Other: Group BElectronic cigarette (nicotine/placebo) - Days 7 through 8 Electronic cigarette exposure will be limited to two days |
| Group C | Experimental | Other: Group CElectronic cigarette (nicotine/placebo) - Days 6 through 8 Electronic cigarette exposure will be limited to 3 days |
| Group D | Experimental | Other: Group DElectronic cigarette (nicotine/placebo) - Days 5 through 8 Electronic cigarette exposure will be limited to 4 days |
| Group E | Experimental | Other: Group EElectronic cigarette (nicotine/placebo) - Days 4 through 8 Electronic cigarette exposure will be limited to 5 days. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AAlso: Electronic cigarette (nicotine/placebo)- Day 890 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 A |
| Group BAlso: Electronic cigarette (nicotine/placebo)- Days 7 and 8On 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 B |
| Group CAlso: Electronic cigarette (nicotine/placebo) - Days 6 through 8On 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 C |
| Group DAlso: Electronic cigarette (nicotine/placebo)- Days 5 through 8On 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 D |
| Group EAlso: Electronic cigarette (nicotine/placebo) - Days 4 through 8On 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 | Group E |
Primary outcome
Airway epithelium and aveolar macrophage
Time frame: 8 days
Changes in airway epithelium and aveolar macrophage will be measured by bronchoscopy
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Derived from this study: PubMed 29754582Staudt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Crystal, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A, Group B and Group C in people with Lung Disease and Lung Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway epithelium and aveolar macrophage (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.