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Electronic Cigarette-derived Oxidants and Cardiopulmonary Effects

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ClinicalTrials.gov Identifier: NCT05239793
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : February 13, 2023
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
John P. Richie, Milton S. Hershey Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: NJOY e-cigarette Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Translational Studies on Electronic Cigarette-derived Oxidants and Their Long-term Cardiopulmonary Effects
Actual Study Start Date : November 22, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arms and Interventions
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Arm Intervention/treatment
NJOY e-cigarette
NJOY e-cigarette containing 5% nicotine strength pods
 Other: NJOY e-cigarette
NJOY e-cigarette with Virginia Tobacco flavored 5% nicotine pods


Outcome Measures
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Primary Outcome Measures :
  1. Cigarettes per day [ Time Frame: 12 months ]
    Self reported cigarettes per day

  2. Number of exacerbations [ Time Frame: 12 months ]
    Number of COPD exacerbations


Secondary Outcome Measures :
  1. Lung function tests (spirometry) [ Time Frame: 12 months ]
    FEV1

  2. COPD Assessment Test (CAT) scores [ Time Frame: 12 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.

  3. 6-min walk distance (6MWD) [ Time Frame: 12 months ]
    This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

  4. Tobacco exposure [ Time Frame: 12 months ]
    Measure by cotinine (ng/ml)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05239793


Contacts
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Contact: Timothy Sheehan 717-531-0003 ext 284024 tsheehan@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: John P. Richie, Ph.D.    717-531-5381    jrichie@hmc.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Rebecca Bascom, MD Penn State Health Hershey Medical Center
Principal Investigator: Raghu Sinha, PhD Penn State Health Hershey Medical Center
More Information
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Responsible Party: John P. Richie, Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT05239793    
Other Study ID Numbers: STUDY00015514
1R01HL152436 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We propose to make de-identified data, codebooks, documentation, and research protocols available to interested researchers after completion of the study.
Supporting Materials: Study Protocol
Time Frame: Data will be available within 3 years of the culmination of data collection activities.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases