Current SmokerNCT02596685
Effects of Electronic Cigarette Use on the Lungs
A study testing Bronchoscopy, Electronic Cigarette and Laboratory Biomarker Analysis in people with Current Smoker and Never Smoker, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies the effects of electronic cigarettes on the lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and Drug Administration (FDA) and other government regulators with important information, which may help in developing future regulations to… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Current Smoker, Never Smoker, Tobacco Use Disorder
- What is being tested?
- Bronchoscopy, Electronic Cigarette and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2015to 2 Feb 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aim 1 only: 1) smokers who smoke at least 10 cigarettes per day with a stable smoking pattern of at least 6 months and no prior e-cig use within one year. Smoking status will be confirmed by salivary cotinine; subjects with at least 10 ng/ml cotinine in their saliva being considered smokers [150]. 2) e-cig users who report using e-cigs daily for 3 months with at least one nicotine-containing cartridge/day or 1 ml of liquid/day. They should have not smoked a cigarette for at least one year. 3) former smokers currently using nicotine-containing e-cigs who have completely switched to e-cigs 1-5 years earlier, and previously smoked >10 cigs/day for >1 year. 4) former-smokers who have quit smoking 1-5 years previously, and who previously smoked >10 cigs/day for >1 year and no e-cig use for a year and <10 days in their lifetime. 5) never-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year. Lack of regular smoking will be confirmed by NicAlert.
- Aim 2 only: Non-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year. Lack of regular smoking will be confirmed by salivary cotinine. Participants should be in good physical and mental health, particularly those randomized to the control condition;
- No unstable and significant medical conditions as determined by medical history (see exclusion criteria below) to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
- Able to read adequately to complete the survey and related study documents or give consent; and
- Subject has provided written informed consent to participate in the study.
Who cannot join
- Immune system disorders, pulmonary diseases (e.g., asthma within the prior 5 years, acute bronchitis within 1 year, COPD, chronic bronchitis, and restrictive lung disease), clinically diagnosed kidney or liver diseases, or any other medical disorders that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use. All subjects are screened by a pulmonologist obtaining a medical history and a physical examination (heart, lungs and oral cavity) to ensure no increased risk from bronchoscopy or e-cig use;
- General anesthesia within one year;
- Use of inhalant medications in the last 3 months;
- Use of antibiotics in prior 30 days;
- Use of steroids, including corticosteroids, in prior 30 days;
- Allergies to study medications, such as, lidocaine, Versed, Fentanyl or Cetacaine
Show all 14Show fewer
- Bronchoscopy or any other lung procedure for any reason within the previous year;
- Current or recent (within three months) alcohol or drug abuse problems, including marijuana use within the last 30 days. Subjects with a positive Tetrahydrocannabinol (THC) strip test at any visit will be excluded;
- Other tobacco use (e.g., combustible products, vapors, etc.) within the last 3 months;
- Other tobacco use within the past year for 7 consecutive days or 14 times.
- Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months;
- BMI > 40 (risk of unstable airway)
- Pregnant or breastfeeding in prior 3 months - If the subject is female, the investigator will provide a urine pregnancy test at no cost to the subject. The subject will take the pregnancy test before each bronchoscopy; and,
- Unable to read for comprehension or completion of study documents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Effects of Electronic Cigarette Use on the Human Lung
This randomized pilot clinical trial studies the effects of electronic cigarettes on the lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and Drug Administration (FDA) and other government regulators with important information, which may help in developing future regulations to make electronic cigarettes safer.
Read the detailed description
PRIMARY OBJECTIVES:
- To conduct a pilot cross-sectional study of e-cig users (n=16), never-smokers (n=8 - completed under an earlier version of the protocol before never-smokers were used for Aim 2), (newly added n=15), former smokers who have quit smoking and are currently not using e-cigs (n=15), former smokers who switched to e-cigs (n=15) and smokers (n=16) [total n=85), to better determine the influence of e-cig and smoking use (i.e., power) between never smokers and e-cig users, and to compare former smokers with e-cig use, and assessing use patterns and biomarkers by bronchoscopies using bronchioalveolar lavage (cell counts, inflammatory cytokines, untargeted metabolomics, and microbiome assessment), bronchial brushings (miRNA and mRNA expression, DNA methylation, acrolein DNA adducts, and mitochondrial DNA mutations and copy number variation), blood and urine to assess exposure to the e-cigs ingredients, saliva for oral microbiome assessment, and nasal brushing and nasal lavages for the lung toxicity as examined in this study as surrogate markers for the lung. We will also measure fractional exhaled nitric oxide (FeNO) as a marker of lower airway inflammation; and,
1a) Conduct a supplemental contamination study to measure if bacteria from oral cavity, nasal cavity or oropharynx may contaminate BAL fluid recovered during the bronchoscopy (n=30). Contamination analyses will measure if bacterial species found in oral cavity, nasal cavity and oropharynx are recovered in BAL. Contamination analyses will not examine differences between groups.
- To conduct a 4 week pilot clinical trial of nicotine-free and flavor-free e-cig use in never-smokers (n=30), randomized to e-cig use (n=15) or control (no e-cig use) (n=15), and assess biomarkers as in Aim 1 by bronchoscopy at baseline and at 4 weeks while on product (week 5 of trial).
OUTLINE:
PART I: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo bronchoscopy of the left lung over 30-60 minutes.
ARM II: Patients undergo bronchoscopy of the right lung over 30-60 minutes.
PART II: Patients who are never-smokers are then randomized to 1 of 2 arms.
ARM A: Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them twice daily (BID) over a 2 hour period for 4 weeks.
ARM B: Patients receive no intervention.
In both arms, patients undergo a second bronchoscopy during week 5.
- Conditions
- Current Smoker, Never Smoker, Tobacco Use Disorder, Former Smoker, E-cig User
- Being tested
- Bronchoscopy, Electronic Cigarette, Laboratory Biomarker Analysis, Questionnaire Administration
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyProcedure or surgery
Undergo bronchoscopy
Electronic CigaretteOther
Also called e-Cigarette, Electronic Nicotine Delivery System
Given nicotine-free and flavor-free electronic cigarettes
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (electronic-cigarette) | Experimental | Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them BID over a 2 hour period for 4 weeks.
Patients undergo a second bronchoscopy during week 5. Receives: Procedure: Bronchoscopy; Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm B (control) | Experimental | Patients receive no intervention.
Patients undergo a second bronchoscopy during week 5. Receives: Procedure: Bronchoscopy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm I (bronchoscopy of the left lung) | Experimental | Patients undergo bronchoscopy of the left lung over 30-60 minutes. Receives: Procedure: Bronchoscopy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm II (bronchoscopy of the right lung) | Experimental | Patients undergo bronchoscopy of the right lung over 30-60 minutes. Receives: Procedure: Bronchoscopy; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker expression analysis to include cell counts
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Measured: Up to week 5
Biomarker expression analysis to include inflammatory cytokines (Part I)
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Measured: Up to week 5
Biomarker expression analysis to include untargeted metabolomics (Part I)
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Measured: Up to week 5
Biomarker expression analysis to include gene expression (Part I)
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Measured: Up to week 5
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (Part II)
Descriptive statistics and plots will be used to informally assess changes in biological parameters between bronchoscopies; repeated measures models may be used to control for possible confounding between the groups as well as provide estimates for future power calculations.
Measured: Baseline to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start8 Dec 2015
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
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 Current SmokerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Shields, Ohio State University Comprehensive Cancer Center
- Investigators
- Peter Shields, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596685
- Sponsor's protocol ID
- OSU-15098
- Other IDs
- NCI-2015-00842
- Status last verified
- Jul 2024
- First submitted
- 8 Oct 2015
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McElroy JP, Song MA, Barr JR, Gardner MS, Kinnebrew G, Kuklenyik Z, Kusovschi JD, Rees JC, Blount BC, Tsai M, Wewers MD, Kamel S, Reisinger SA, Singh A, Weng DY, Shields PG. Lung lipids associated with smoking and ECIG use in a cross-sectional study and clinical trial. Respir Res. 2025 May 20;26(1):193. doi: 10.1186/s12931-025-03267-w.
PubMed 40394619
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electronic Cigarette Use on the Human Lung
- ClinicalTrials.gov ID
- NCT02596685
- Acronym / sponsor ID
- OSU-15098
- Conditions
- Current Smoker, Never Smoker, Tobacco Use Disorder, Former Smoker, E-cig User
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 4 Nov 2015 (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.
This randomized pilot clinical trial studies the effects of electronic cigarettes on the lungs. Studying the effects of electronic cigarettes on the lungs may provide the Food and Drug Administration (FDA) and other government regulators with important information, which may help in developing future regulations to make electronic cigarettes safer.
Detailed description
PRIMARY OBJECTIVES:
- To conduct a pilot cross-sectional study of e-cig users (n=16), never-smokers (n=8 - completed under an earlier version of the protocol before never-smokers were used for Aim 2), (newly added n=15), former smokers who have quit smoking and are currently not using e-cigs (n=15), former smokers who switched to e-cigs (n=15) and smokers (n=16) [total n=85), to better determine the influence of e-cig and smoking use (i.e., power) between never smokers and e-cig users, and to compare former smokers with e-cig use, and assessing use patterns and biomarkers by bronchoscopies using bronchioalveolar lavage (cell counts, inflammatory cytokines, untargeted metabolomics, and microbiome assessment), bronchial brushings (miRNA and mRNA expression, DNA methylation, acrolein DNA adducts, and mitochondrial DNA mutations and copy number variation), blood and urine to assess exposure to the e-cigs ingredients, saliva for oral microbiome assessment, and nasal brushing and nasal lavages for the lung toxicity as examined in this study as surrogate markers for the lung. We will also measure fractional exhaled nitric oxide (FeNO) as a marker of lower airway inflammation; and,
1a) Conduct a supplemental contamination study to measure if bacteria from oral cavity, nasal cavity or oropharynx may contaminate BAL fluid recovered during the bronchoscopy (n=30). Contamination analyses will measure if bacterial species found in oral cavity, nasal cavity and oropharynx are recovered in BAL. Contamination analyses will not examine differences between groups.
- To conduct a 4 week pilot clinical trial of nicotine-free and flavor-free e-cig use in never-smokers (n=30), randomized to e-cig use (n=15) or control (no e-cig use) (n=15), and assess biomarkers as in Aim 1 by bronchoscopy at baseline and at 4 weeks while on product (week 5 of trial).
OUTLINE:
PART I: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo bronchoscopy of the left lung over 30-60 minutes.
ARM II: Patients undergo bronchoscopy of the right lung over 30-60 minutes.
PART II: Patients who are never-smokers are then randomized to 1 of 2 arms.
ARM A: Patients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them twice daily (BID) over a 2 hour period for 4 weeks.
ARM B: Patients receive no intervention.
In both arms, patients undergo a second bronchoscopy during week 5.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A (electronic-cigarette) | Experimental | Procedure: Bronchoscopy, Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients receive nicotine-free and flavor-free electronic cigarettes and instructed to use them BID over a 2 hour period for 4 weeks. Patients undergo a second bronchoscopy during week 5. |
| Arm B (control) | Experimental | Procedure: Bronchoscopy, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients receive no intervention. Patients undergo a second bronchoscopy during week 5. |
| Arm I (bronchoscopy of the left lung) | Experimental | Procedure: Bronchoscopy, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients undergo bronchoscopy of the left lung over 30-60 minutes. |
| Arm II (bronchoscopy of the right lung) | Experimental | Procedure: Bronchoscopy, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients undergo bronchoscopy of the right lung over 30-60 minutes. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aim 1 only: 1) smokers who smoke at least 10 cigarettes per day with a stable smoking pattern of at least 6 months and no prior e-cig use within one year. Smoking status will be confirmed by salivary cotinine; subjects with at least 10 ng/ml cotinine in their saliva being considered smokers [150]. 2) e-cig users who report using e-cigs daily for 3 months with at least one nicotine-containing cartridge/day or 1 ml of liquid/day. They should have not smoked a cigarette for at least one year. 3) former smokers currently using nicotine-containing e-cigs who have completely switched to e-cigs 1-5 years earlier, and previously smoked >10 cigs/day for >1 year. 4) former-smokers who have quit smoking 1-5 years previously, and who previously smoked >10 cigs/day for >1 year and no e-cig use for a year and <10 days in their lifetime. 5) never-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year. Lack of regular smoking will be confirmed by NicAlert.
- Aim 2 only: Non-smokers who have smoked less than 100 cigarettes in their lifetime and not for at least 1 year, and not have used an e-cig for at least 1 year. Lack of regular smoking will be confirmed by salivary cotinine. Participants should be in good physical and mental health, particularly those randomized to the control condition;
- No unstable and significant medical conditions as determined by medical history (see exclusion criteria below) to ensure safety of the subject, to minimize the effects of poor health on biomarker measures and to maximize compliance to study procedures);
- Able to read adequately to complete the survey and related study documents or give consent; and
- Subject has provided written informed consent to participate in the study.
Key exclusion criteria (14 listed)
- Immune system disorders, pulmonary diseases (e.g., asthma within the prior 5 years, acute bronchitis within 1 year, COPD, chronic bronchitis, and restrictive lung disease), clinically diagnosed kidney or liver diseases, or any other medical disorders that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use. All subjects are screened by a pulmonologist obtaining a medical history and a physical examination (heart, lungs and oral cavity) to ensure no increased risk from bronchoscopy or e-cig use;
- General anesthesia within one year;
- Use of inhalant medications in the last 3 months;
- Use of antibiotics in prior 30 days;
- Use of steroids, including corticosteroids, in prior 30 days;
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 |
|---|---|---|
| BronchoscopyUndergo bronchoscopy | Procedure or surgery | Arm A (electronic-cigarette), Arm B (control), Arm I (bronchoscopy of the left lung), Arm II (bronchoscopy of the right lung) |
| Electronic CigaretteAlso: e-Cigarette, Electronic Nicotine Delivery SystemGiven nicotine-free and flavor-free electronic cigarettes | Other | Arm A (electronic-cigarette) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (electronic-cigarette), Arm B (control), Arm I (bronchoscopy of the left lung), Arm II (bronchoscopy of the right lung) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (electronic-cigarette), Arm B (control), Arm I (bronchoscopy of the left lung), Arm II (bronchoscopy of the right lung) |
Primary outcome
Biomarker expression analysis to include cell counts
Time frame: Up to week 5
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Biomarker expression analysis to include inflammatory cytokines (Part I)
Time frame: Up to week 5
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Biomarker expression analysis to include untargeted metabolomics (Part I)
Time frame: Up to week 5
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Biomarker expression analysis to include gene expression (Part I)
Time frame: Up to week 5
Using bronchoalveolar lavage, and bronchial brushings for gene expression use patterns and biomarkers will be assessed and compared between two groups (e.g., non-smokers vs. smokers). For univariable comparisons, non-parametric methods such as the Kruskal-Wallis H-test for more than two independent groups and the Mann Whitney U-test for two independent groups will be used. Group associations controlling for possible confounders or effect modifiers will be explored using multiple linear regression models.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (Part II)
Time frame: Baseline to 5 weeks
Descriptive statistics and plots will be used to informally assess changes in biological parameters between bronchoscopies; repeated measures models may be used to control for possible confounding between the groups as well as provide estimates for future power calculations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 40394619McElroy JP, Song MA, Barr JR, Gardner MS, Kinnebrew G, Kuklenyik Z, Kusovschi JD, Rees JC, Blount BC, Tsai M, Wewers MD, Kamel S, Reisinger SA, Singh A, Weng DY, Shields PG. Lung lipids associated with smoking and ECIG use in a cross-sectional study and clinical trial. Respir Res. 2025 May 20;26(1):193. doi: 10.1186/s12931-025-03267-w.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Peter Shields, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy, Electronic Cigarette and Laboratory Biomarker Analysis in people with Current Smoker and Never Smoker, run by Ohio State University Comprehensive Cancer Center 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 30 Jul 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biomarker expression analysis to include cell counts (time frame: Up to week 5). The study lists 5 primary outcomes in all. 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 NCT02596685, 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 30 Jul 2024.