Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03691350
Other study ID # OSU-18044
Secondary ID NCI-2018-00283U0
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 17, 2018
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source Ohio State University Comprehensive Cancer Center
Contact Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 identify biomarkers related to cancer.


Description:

PRIMARY OBJECTIVES: I. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 239
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 52 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bronchoscopy with Bronchoalveolar Lavage
Undergo bronchoscopy with bronchoalveolar lavage
Drug:
Cigarette
Smoke usual brand
Other:
Electronic Cigarette
Smoke SREC with nicotine
Electronic Cigarette
Smoke SREC without nictoine
Laboratory Biomarker Analysis
Correlative studies
Drug:
Nicotine Replacement
Receive NRT comprising patch, gum, or lozenge
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in cell counts and 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. Baseline to day 71
Secondary 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. Baseline up to day 71
Secondary 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. Baseline up to day 71
Secondary 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. Baseline up to day 71
Secondary 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. Baseline up to day 71
Secondary 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. Baseline up to day 71
See also
  Status Clinical Trial Phase
Completed NCT01967082 - APPSPIRE App in Preventing Students From Smoking N/A
Recruiting NCT03865472 - rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers N/A
Active, not recruiting NCT02271919 - Varenicline and Combined NRT for Smoking Cessation Phase 4
Withdrawn NCT03668769 - Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking N/A
Completed NCT02575885 - Nicotine Delivery From Novel Non-Tobacco Electronic System in Smokers N/A
Completed NCT04060446 - Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
Completed NCT00941395 - Enhanced Smoking Cessation for University Students N/A
Recruiting NCT03199651 - Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer N/A
Recruiting NCT03824535 - 18F-FSPG PET/CT in Diagnosing Early Lung Cancer in Patients With Lung Nodules Phase 2
Completed NCT00468234 - Validation of Biomarkers of Exposure and Host Response N/A
Completed NCT00850954 - Project CASA in Promoting Smoke-Free Indoor Air Policy in Mexican American Households N/A
Active, not recruiting NCT02697227 - Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation N/A
Completed NCT03669120 - Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking N/A
Completed NCT00948129 - Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers N/A

External Links