Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
NCT Number: NCT05239793
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.
This study is active but is not currently recruiting participants.
21 year–74 year
All sexes
Interventional
Early Phase 1
Hershey, Pennsylvania, 17033, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods
Time frame: 3 months
Self reported cigarettes per day
Time frame: 3 months
Number of COPD exacerbations
Time frame: 3 months
FEV1
Time frame: 3 months
8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Time frame: 3 months
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time frame: 3 months
Measure by cotinine (ng/ml)
Milton S. Hershey Medical Center
Other
Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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