NCT03691350

Bronchoscopy in Determining the Effect of E-Cigarette Smoking on Biomarkers in the Lungs

The Effects of a Standardized Research E-Cigarette on the Human Lung: A Clinical Trial With Bronchoscopic Biomarkers

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 239 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 52 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cigarette Smoker
• Current Every Day Smoker

Interventions

Type	Name	Description
PROCEDURE	Bronchoscopy with Bronchoalveolar Lavage	Undergo bronchoscopy with bronchoalveolar lavage
DRUG	Cigarette	Smoke usual brand
OTHER	Electronic Cigarette	Smoke SREC with nicotine
OTHER	Electronic Cigarette	Smoke SREC without nictoine
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nicotine Replacement	Receive NRT comprising patch, gum, or lozenge
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-09-17
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-10-01
• Last updated: 2023-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study