Examining the effects of e-cigarette smoking on lung health
The Effects of a Standardized Research E-Cigarette on the Human Lung: A Clinical Trial With Bronchoscopic Biomarkers
This study is testing how switching from regular cigarettes to different types of e-cigarettes or nicotine replacement therapy affects lung health in daily smokers over 10 weeks.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 239 (estimated) |
| Ages | 21 Years to 52 Years |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03691350 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of e-cigarette smoking on lung biomarkers through bronchoscopy, which includes bronchoalveolar lavage and lung brushings. Participants, who are daily smokers, will be randomized into four groups: continuing their usual cigarette brand, switching to nicotine e-cigarettes, switching to nicotine-free e-cigarettes, or using nicotine replacement therapy. Over a period of 10 weeks, inflammatory changes in lung and urine biomarkers will be assessed through serial bronchoscopy. The goal is to identify changes in lung cells that may be linked to cancer.
Who should consider this trial
Good fit: Ideal candidates are smokers who consume at least 5 filtered cigarettes per day for over a year and have no significant medical conditions.
Not a fit: Patients with chronic pulmonary diseases or significant medical disorders that could complicate bronchoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the harmful effects of e-cigarettes on lung health and inform smoking cessation strategies.
How similar studies have performed: While there is ongoing research into the effects of e-cigarettes, this specific approach using bronchoscopy to assess lung biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Peter Shields, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.