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Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NJOY e-cigarette
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

21 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild to moderate COPD defined as (GOLD Grade 1-2 and Groups A-B)
  • 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

Sites / Locations

  • Penn State Health Milton S. Hershey Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NJOY e-cigarette

Arm Description

NJOY e-cigarette containing 5% nicotine strength pods

Outcomes

Primary Outcome Measures

Cigarettes per day
Self reported cigarettes per day
Number of exacerbations
Number of COPD exacerbations

Secondary Outcome Measures

Lung function tests (spirometry)
FEV1
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.
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.
Tobacco exposure
Measure by cotinine (ng/ml)

Full Information

First Posted
February 4, 2022
Last Updated
February 9, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05239793
Brief Title
Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects
Official Title
Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NJOY e-cigarette
Arm Type
Other
Arm Description
NJOY e-cigarette containing 5% nicotine strength pods
Intervention Type
Other
Intervention Name(s)
NJOY e-cigarette
Intervention Description
NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods
Primary Outcome Measure Information:
Title
Cigarettes per day
Description
Self reported cigarettes per day
Time Frame
12 months
Title
Number of exacerbations
Description
Number of COPD exacerbations
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lung function tests (spirometry)
Description
FEV1
Time Frame
12 months
Title
COPD Assessment Test (CAT) scores
Description
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
12 months
Title
6-min walk distance (6MWD)
Description
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Time Frame
12 months
Title
Tobacco exposure
Description
Measure by cotinine (ng/ml)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Sheehan
Phone
717-531-0003
Ext
284024
Email
tsheehan@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Bascom, MD
Organizational Affiliation
Penn State Health Hershey Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raghu Sinha, PhD
Organizational Affiliation
Penn State Health Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John P. Richie, Ph.D.
Phone
717-531-5381
Email
jrichie@hmc.psu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.
IPD Sharing Time Frame
Data will be available within 3 years of the culmination of data collection activities.
IPD Sharing Access Criteria
Any investigator interested in collaboration or in using the data collected in this study for their own work will be invited to submit a 1-page abstract of their proposed research, including purpose, analytical plan, and dissemination plans. The study leadership team will review these proposals and decide on each based on the individual merits. Review criteria and prioritization of projects include: potential of the proposed work to advance public health, qualifications of the applicant, the potential for publication, the potential for future funding, and enhancing the scientific, geographic, and demographic diversity of the research portfolio.

Learn more about this trial

Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

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