Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes

NCT05610514 | Completed Phase 2 DMC

• 2 other identifiers: STUDY00000511U54DA036114-07
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of e-cigarettes and continued smoking on pulmonary and cardiac outcomes in a population with established pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Asthma-COPD Overlap Syndrome

Keywords

chronic obstructive pulmonary disease; pulmonary; cardiac; cigarettes; e-cigarettes; smokers

Outcome Measures

Primary Outcomes (23)

• Baseline FEV1/FVC Ratio

  Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry

  Intake assessment

• Change from Baseline FEV1/FVC Ratio each day

  Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry

  Daily through study completion, an average of 4 weeks

• Change from Baseline FEV1/FVC Ratio at 2 weeks

  Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry

  Assessment completed 2 weeks after intake assessment

• Change from Baseline FEV1/FVC Ratio at 4 weeks

  Ratio of the amount of air forced from the lungs in one second (Forced Expiratory Volume in the First Second; FEV1) to the amount of air forced from the lungs throughout an entire measurement (Forced Vital Capacity; FVC), as assessed via spirometry

  Assessment completed 4 weeks after intake assessment

• Baseline Lung Reactance at 5Hz (X5)

  Measurement of the ability of the lung to store energy, as measured by oscillometry

  Intake assessment

• Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks

  Measurement of the ability of the lung to store energy, as measured by oscillometry

  Assessment completed 2 weeks after intake assessment

• Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks

  Measurement of the ability of the lung to store energy, as measured by oscillometry

  Assessment completed 4 weeks after intake assessment

• Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)

  Airway impedence in the lungs as measured by oscillometry

  Intake assessment

• Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks

  Airway impedence in the lungs as measured by oscillometry

  Assessment completed 2 weeks after intake assessment

• Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks

  Airway impedence in the lungs as measured by oscillometry

  Assessment completed 4 weeks after intake assessment

• Baseline Oxygen Saturation (SpO2)

  Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  Intake assessment

• Change from Baseline Oxygen Saturation (SpO2) each day

  Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  Daily through study completion, an average of 4 weeks

• Change from Baseline Oxygen Saturation (SpO2) at 2 weeks

  Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  Assessment completed 2 weeks after intake assessment

• Change from Baseline Oxygen Saturation (SpO2) at 4 weeks

  Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry

  Assessment completed 4 weeks after intake assessment

• Baseline Fractional Exhaled Nitric Oxide (FeNO)

  Amount of nitric oxide in the breath

  Intake assessment

• Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks

  Amount of nitric oxide in the breath

  Assessment completed 2 weeks after intake assessment

• Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks

  Amount of nitric oxide in the breath

  Assessment completed 4 weeks after intake assessment

• Baseline COPD Assessment Test Score

  Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome

  Intake assessment

• Change from Baseline COPD Assessment Test Score at 2 weeks

  Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome

  Assessment completed 2 weeks after intake assessment

• Change from Baseline COPD Assessment Test Score at 4 weeks

  Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome

  Assessment completed 4 weeks after intake assessment

• Baseline St. George's Respiratory Questionnaire for COPD Patients Score

  Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health

  Intake assessment

• Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks

  Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health

  Assessment completed 2 weeks after intake assessment

• Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks

  Score measuring the impact of COPD on overall health, daily life, and perceived well-being; scale of 0-100; higher scores indicate more limitations on overall health

  Assessment completed 4 weeks after intake assessment

Secondary Outcomes (8)

• Baseline Blood Pressure

  Intake assessment

• Change from Baseline Blood Pressure each day

  Daily through study completion, an average of 4 weeks

• Change from Baseline Blood Pressure at 2 weeks

  Assessment completed 2 weeks after intake assessment

• Change from Baseline Blood Pressure at 4 weeks

  Assessment completed 4 weeks after intake assessment

• Baseline Heart Rate

  Intake assessment

Other Outcomes (16)

• Baseline Carbon Monoxide (CO)

  Intake assessment

• Change from Baseline Carbon Monoxide (CO) each day

  Daily through study completion, an average of 4 weeks

• Change from Baseline Carbon Monoxide (CO) at 2 weeks

  Assessment completed 2 weeks after intake assessment

Study Arms (2)

Combustible Cigarette

NO INTERVENTION

Participants in this arm will smoke their usual brand of combustible cigarettes for two weeks.

E-Cigarette

EXPERIMENTAL

Participants in this arm will smoke electronic cigarettes for two weeks. E-cigarettes (either JUUL or Vuse Alto) and pods (JUUL: Virginia tobacco flavor at 3% or 5% nicotine concentration; Vuse Alto: golden tobacco flavor at 1.8%, 2.4%, or 5% nicotine concentration) will be provided.

Other: E-Cigarette; Behavioral: Financial Incentives

Interventions

E-Cigarette OTHER

Altering the availability of e-cigarettes

E-Cigarette

Financial Incentives BEHAVIORAL

Altering the availability of financial incentives for abstaining from combustible cigarettes

E-Cigarette

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 40 years of age or older
• Current, every day smoker (5 or more cigarettes per day for one year or longer) confirmed with intake CO of 8ppm or greater
• Established pulmonary disease (chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, emphysema, or asthma-COPD overlap syndrome) confirmed by physician diagnosis and/or current prescription of medication for treatment (i.e., LABA, LAMA, +/- ICS, or combination)
• Lives and plans to remain in the greater Burlington, VT area for the next month
• No intention to quit smoking within the next month
• Speaks English

You may not qualify if:

• Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
• Inability to conduct in-home measurements.

Sponsors & Collaborators

• University of Vermont: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Vermont Center on Behavior and Health

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Asthma; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Diann E Gaalema, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 9, 2022
• Study Start: April 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)