Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239793
• Other study ID #: STUDY00015514
• Secondary ID: 1R01HL152436
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Milton S. Hershey Medical Center
• Contact: Timothy Sheehan
• Phone: 717-531-0003
• Email: tsheehan[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 74 Years

Eligibility

Inclusion Criteria:

• Mild to moderate COPD

• Smokes a popular brand of cigarette

• Willing to use an e-cigarette to reduce cigarette smoking down to 75% of their daily baseline cigarette use

• Ability to read, write and understand English

• Ability to provide informed consent and attend study visits

Exclusion Criteria:

• History of active, chronic drug abuse or alcohol abuse problems

• Actively changing smoking behavior

• Unwilling or unable to provide blood samples

• Pregnant, planning to become pregnant, or nursing

• Use of tobacco products other than cigarettes in the past 30 days

• Recent history (< 6 months) of myocardial infarction (MI)

• Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or drug therapy within the past year. Antiarrhythmic drugs include amiodarone, flecainide, IV ibutilide, IV lidocaine, procainamide, propafenone, quinidine, tocainide

• Hospitalization for heart failure (NY Heart Association III or IV) within the past year

• Uncontrolled hypertension

• Known allergy to vegetable glycerin and propylene glycol

• History of seizures or medications to prevent seizures

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• NJOY e-cigarette
NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods

Locations

Country	Name	City	State
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes per day	Self reported cigarettes per day	3 months
Primary	Number of exacerbations	Number of COPD exacerbations	3 months
Secondary	Lung function tests (spirometry)	FEV1	3 months
Secondary	COPD Assessment Test (CAT) scores	8-item scale with range of scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.	3 months
Secondary	6-min walk distance (6MWD)	This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.	3 months
Secondary	Tobacco exposure	Measure by cotinine (ng/ml)	3 months