Cigarette SmokerEarly Phase 1NCT03691350
Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs
A Early Phase 1 study testing Bronchoscopy with Bronchoalveolar Lavage, Cigarette and Electronic Cigarette in people with Cigarette Smoker and Current Every Day Smoker, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and… Read more about this study
- Who is it for?
- Ages 21 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker
- What is being tested?
- Bronchoscopy with Bronchoalveolar Lavage, Cigarette and Electronic Cigarette
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 10 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smokers who smoke >= 5 filtered cigarettes/day for >= 1 year
- No unstable or significant medical conditions as determined by medical history 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
- Subject has provided written informed consent to participate in the study
Who cannot join
- Regular consumption of roll your own cigarettes
- Immune system disorders requiring medication
- Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic obstructive pulmonary disease [COPD], chronic bronchitis, and restrictive lung disease)
- Acute bronchitis or pneumonia within 1 year
- Reported history of diagnosed kidney or liver disease
- Any medical disorder that will increase the risk from bronchoscopy, affect biomarker data, or increase risk of an adverse effect from e-cig use
Show all 22Show fewer
- General anesthesia within 1 year
- Regular use of inhalant medications in the last 2 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
- Allergies to propylene glycol/glycerin or flavors
- History of hypersensitivity to varenicline
- Bronchoscopy or any other lung procedure for any reason within the previous 6 months
- Current or recent (within three months) alcohol or drug abuse problems
- Regularly smoked marijuana within the prior 3 months
- Use of an e-cigarette or other combustible tobacco products in the prior 3 months
- Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product) or intention to quit in next three months
- Adverse reaction to previous e-cig use
- Body mass index (BMI) > 40 (risk of unstable airway)
- Pregnant or breastfeeding - if the subject is female, a urine pregnancy test at no cost to the subject will be done on the day of bronchoscopy
- 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: The Effects of a Standardized Research E-Cigarette on the Human Lung: A Clinical Trial With Bronchoscopic Biomarkers
This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and identify biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess inflammatory changes over 10 weeks for lung and urine biomarkers in smokers who undergo serial bronchoscopy. The randomized trial includes four conditions: continued use (n=32), complete switching to the nicotine standardized research electronic cigarettes (e-cig) (SREC) (n=32), complete switching to the placebo (nicotine free) SREC (n=32), and complete switching to nicotine replacement therapy (NRT)(n=32).
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71.
GROUP II: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.
GROUP III: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71.
GROUP IV: Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71.
After completion of study, participants are followed up at 3 months.
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Being tested
- Bronchoscopy with Bronchoalveolar Lavage, Cigarette, Electronic Cigarette, Laboratory Biomarker Analysis, Nicotine Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy with Bronchoalveolar LavageProcedure or surgery
Also called bronchial washing, Bronchoscopy/Lavage
Undergo bronchoscopy with bronchoalveolar lavage
CigaretteDrug
Smoke usual brand
Electronic CigaretteOther
Also called e-Cigarette, Electronic Nicotine Delivery System
Smoke SREC with nicotine
Electronic CigaretteOther
Also called e-Cigarette, Electronic Nicotine Delivery System
Smoke SREC without nictoine
Laboratory Biomarker AnalysisOther
Correlative studies
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Receive NRT comprising patch, gum, or lozenge
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (usual cigarette brand) | Active comparator | Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71. Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage; Drug: Cigarette; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Group II (SREC with nicotine) | Experimental | Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71. Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Group III (SREC without nicotine) | Experimental | Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week after bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71. Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Electronic Cigarette; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Group IV (Nicotine Replacement Therapy [NRT]) | Experimental | Participants undergo bronchoscopy over 30-60 minutes at baseline. One week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71. Receives: Procedure: Bronchoscopy with Bronchoalveolar Lavage; Other: Laboratory Biomarker Analysis; Drug: Nicotine Replacement; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cytokines
Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm.
Measured: Baseline to day 71
Changes in Cell Counts
Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm.
Measured: Baseline to day 71
Secondary outcomes (5)
Changes in Fractional Exhaled Nitric Oxide (FeNO) Levels
FeNO will be measured with the NIOX VERO. Descriptive statistics and clustering (e.g. PCA), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way ANOVA. The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the SREC (with and without nicotine) or NRT. GLM will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm.
Measured: Baseline up to day 71
Changes in Messenger (m) Ribonucleic Acid (RNA) and microRNA (miRNA) Gene Expression Analyzed Using Sequencing
Total RNA containing small RNAs will be extracted from bronchial brushing specimens using commercially available kits and used for both gene expression using the Affymetrix GeneChip Human Transcriptome Array and for miRNA expression using the Affymetrix GeneChip miRNA Array. Expression will separately be assessed through RNA sequencing. Total RNA will be extracted from lavage cells and saliva for comprehensive profiling of microbiome using commercially available kits. The ?omics? (miRNA, mRNA, and metabolomics) analysis and visualization of the data will be performed in the R statistical language. Data will be log2-transformed and normalized using either quantile normalization for gene expression (miRNA and mRNA) or normalization for metabolomics. Unsupervised clustering analysis, including PCA and hierarchical clustering will be performed to visualize natural clusters in the dataset and evaluate data quality.
Measured: Baseline up to day 71
Changes in Deoxyribonucleic Acid (DNA) Gene Methylation
Total DNA will be extracted using commercially available kits and used for genome-wide DNA methylation profiling. Total DNA including mitochondrial DNA (mtDNA) will be extracted using commercially available kits and used for mtDNA mutation using Hiseq Next Generation Sequencing (NGS) and for mtDNA contents using quantitative polymerase chain reaction (qPCR). For preliminary identification of patterns in DNA methylation, unsupervised hierarchical clustering among the groups of samples will be performed. The Euclidian distance among the groups of samples will be calculated by the average linkage. In order to assess variance among samples, PCA will be done.
Measured: Baseline up to day 71
Changes in the Microbiome in BAL Cells and Saliva
Obtained via bronchoscopy with saline BAL and bronchial brushings. Samples will be analyzed to determine their bacterial composition.
Measured: Baseline up to day 71
Changes in Untargeted Metabolomics Using Mass Spectrometry
Obtained via bronchoscopy with saline BAL and bronchial brushings. The omics (miRNA, mRNA, and metabolomics) analysis and visualization of the data will be performed in the R statistical language. Data will be log2-transformed and normalized using either quantile normalization for gene expression (miRNA and mRNA) or normalization for metabolomics. Unsupervised clustering analysis, including PCA and hierarchical clustering will be performed to visualize natural clusters in the dataset and evaluate data quality.
Measured: Baseline up to day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start17 Sep 2018
- Primary completion23 Oct 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigarette 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- 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
- NCT03691350
- Sponsor's protocol ID
- OSU-18044
- Other IDs
- NCI-2018-00283, U01DA045530
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2018
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Standardized Research E-Cigarette on the Human Lung: A Clinical Trial With Bronchoscopic Biomarkers
- ClinicalTrials.gov ID
- NCT03691350
- Acronym / sponsor ID
- OSU-18044
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies biomarkers obtained by bronchoscopy (bronchoalveolar lavage and lung brushings) to determine the effect of smoking e-cigarettes on the lungs. Studying samples of lung cells from participants who smoke e-cigarettes may help doctors learn more about changes that occur in deoxyribonucleic acid and identify biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- To assess inflammatory changes over 10 weeks for lung and urine biomarkers in smokers who undergo serial bronchoscopy. The randomized trial includes four conditions: continued use (n=32), complete switching to the nicotine standardized research electronic cigarettes (e-cig) (SREC) (n=32), complete switching to the placebo (nicotine free) SREC (n=32), and complete switching to nicotine replacement therapy (NRT)(n=32).
OUTLINE: Participants are randomized to 1 of 4 groups.
GROUP I: Participants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71.
GROUP II: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71.
GROUP III: Participants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71.
GROUP IV: Participants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71.
After completion of study, participants are followed up at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (usual cigarette brand) | Active comparator | Procedure: Bronchoscopy with Bronchoalveolar Lavage, Drug: Cigarette, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants undergo bronchoscopy over 30-60 minutes at baseline. Participants continue to smoke their usual brand of cigarettes. Participants undergo a second bronchoscopy on day 71. |
| Group II (SREC with nicotine) | Experimental | Procedure: Bronchoscopy with Bronchoalveolar Lavage, Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants undergo bronchoscopy over 30-60 minutes at baseline. After the baseline bronchoscopy, participants learn to use the SREC with nicotine for 2 weeks and switch completely to the SREC with nicotine starting day 15 for 8 weeks. Participants undergo a second bronchoscopy on day 71. |
| Group III (SREC without nicotine) | Experimental | Procedure: Bronchoscopy with Bronchoalveolar Lavage, Other: Electronic Cigarette, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationParticipants undergo bronchoscopy over 30-60 minutes at baseline. Beginning 1 week after bronchoscopy, participants learn to use the SREC without nicotine for 2 weeks and switch completely to the SREC without nicotine starting day 15 for 8 weeks. Participants will be offered varenicline to aid cessation. Participants undergo a second bronchoscopy on day 71. |
| Group IV (Nicotine Replacement Therapy [NRT]) | Experimental | Procedure: Bronchoscopy with Bronchoalveolar Lavage, Other: Laboratory Biomarker Analysis, Drug: Nicotine Replacement, Other: Questionnaire AdministrationParticipants undergo bronchoscopy over 30-60 minutes at baseline. One week before the day 15 quit date, participants stop smoking using NRT comprising either patch, gum, or lozenge for 8 weeks. Participants undergo a second bronchoscopy on day 71. |
Who may qualify
- Ages
- 21 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Smokers who smoke >= 5 filtered cigarettes/day for >= 1 year
- No unstable or significant medical conditions as determined by medical history 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
- Subject has provided written informed consent to participate in the study
Key exclusion criteria (22 listed)
- Regular consumption of roll your own cigarettes
- Immune system disorders requiring medication
- Prior diagnosis of chronic pulmonary disease (e.g., asthma with regular use of medications, chronic obstructive pulmonary disease [COPD], chronic bronchitis, and restrictive lung disease)
- Acute bronchitis or pneumonia within 1 year
- Reported history of diagnosed kidney or liver disease
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 |
|---|---|---|
| Bronchoscopy with Bronchoalveolar LavageAlso: bronchial washing, Bronchoscopy/LavageUndergo bronchoscopy with bronchoalveolar lavage | Procedure or surgery | Group I (usual cigarette brand), Group II (SREC with nicotine), Group III (SREC without nicotine), Group IV (Nicotine Replacement Therapy [NRT]) |
| CigaretteSmoke usual brand | Drug | Group I (usual cigarette brand) |
| Electronic CigaretteAlso: e-Cigarette, Electronic Nicotine Delivery SystemSmoke SREC with nicotine | Other | Group II (SREC with nicotine) |
| Electronic CigaretteAlso: e-Cigarette, Electronic Nicotine Delivery SystemSmoke SREC without nictoine | Other | Group III (SREC without nicotine) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (usual cigarette brand), Group II (SREC with nicotine), Group III (SREC without nicotine), Group IV (Nicotine Replacement Therapy [NRT]) |
| Nicotine ReplacementAlso: Nicotine Replacement Therapy, NRTReceive NRT comprising patch, gum, or lozenge | Drug | Group IV (Nicotine Replacement Therapy [NRT]) |
| Questionnaire AdministrationAncillary studies | Other | Group I (usual cigarette brand), Group II (SREC with nicotine), Group III (SREC without nicotine), Group IV (Nicotine Replacement Therapy [NRT]) |
Primary outcome
Changes in Cytokines
Time frame: Baseline to day 71
Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm.
Changes in Cell Counts
Time frame: Baseline to day 71
Obtained via bronchoscopy with saline bronchoalveolar lavage (BAL) and bronchial brushings. Descriptive statistics and clustering (e.g., principal components analysis [PCA]), will be performed for all biomarker data measured at the different visits. Baseline data (1st bronchoscopy) will then be compared between the four groups (3 conditions and control) using a one-way analysis of variance (ANOVA). The non-parametric Kruskal-Wallis test (continuous or ordinal variables) or the chi-square test (categorical variables) will be applied when the normality assumption of the data is not met. Controls will be compared to complete substitution with the standardized research electronic cigarettes (SREC) (with and without nicotine) or nicotine replacement therapy (NRT. Generalized linear models (GLM) will be employed with measurement (cell count, gene expression, etc.) as the dependent variable, a covariable for baseline measure, and a main effect of arm.
5 secondary outcomes
Changes in Fractional Exhaled Nitric Oxide (FeNO) Levels
Time frame: Baseline up to day 71
Changes in Messenger (m) Ribonucleic Acid (RNA) and microRNA (miRNA) Gene Expression Analyzed Using Sequencing
Time frame: Baseline up to day 71
Changes in Deoxyribonucleic Acid (DNA) Gene Methylation
Time frame: Baseline up to day 71
Changes in the Microbiome in BAL Cells and Saliva
Time frame: Baseline up to day 71
Changes in Untargeted Metabolomics Using Mass Spectrometry
Time frame: Baseline up to day 71
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Early Phase 1 study testing Bronchoscopy with Bronchoalveolar Lavage, Cigarette and Electronic Cigarette in people with Cigarette Smoker and Current Every Day 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 4 inclusion and 22 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 23 Apr 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Cytokines (time frame: Baseline to day 71). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.