NCT05239793

Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study on the impact of switching from cigarettes to Electronic Cigarettes (EC) on disease-related clinical symptoms and biomarkers of harm in smokers with preexisting Chronic Obstructive Pulmonary Disease (COPD). The researchers hypothesize that the smokers who switch to EC completely or significantly will experience reduced COPD symptoms, risks of exacerbations, and decreased levels of oxidative stress and inflammation.

Detailed description

Smokers with COPD have a higher pack-year history and nicotine dependence compared to regular smokers as exemplified by the relatively large proportion of patients diagnosed with COPD that continue to smoke (95%). This is a translational project which addresses the changing profile of tobacco product use in the United States (US) and the need for data regarding toxicity pathways for new nicotine products such as EC. In particular it focuses on critical scientific and clinically relevant gaps relating to oxidants in EC and their potential long-term cardiopulmonary effects. The study will obtain new information regarding the potential cardiopulmonary toxicity resulting from exposure to EC-derived oxidants that may lead to long-term disease development.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	NJOY e-cigarette	NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods

Timeline

• Start date: 2022-11-22
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2022-02-15
• Last updated: 2025-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study