Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Change from Baseline FEV1/FVC Ratio at 2 weeks
Study Overview
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.
Detailed Description
E-cigarettes with nicotine can affect important cardiopulmonary outcomes and likely pose less risk than cigarettes, but they are not harmless. Given the existing literature, there is a need for controlled trials of e-cigarette use in populations with cardiopulmonary disease to fill the gaps between these existing examinations. Clarifying how the pulmonary and cardiac effects of e-cigarettes compare to use of conventional cigarettes in those with cardiopulmonary disease beyond single acute exposures will provide important new health information that can help inform policy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients who are medically unstable (unstable symptoms, changes in medications or hospitalizations within last 3 months)
- •Inability to conduct in-home measurements.
Outcomes
Primary Outcomes
Change from Baseline FEV1/FVC Ratio at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
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
Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
Time Frame: Intake assessment
Airway impedence in the lungs as measured by oscillometry
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
Airway impedence in the lungs as measured by oscillometry
Baseline FEV1/FVC Ratio
Time Frame: Intake assessment
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
Change from Baseline FEV1/FVC Ratio at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
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
Baseline Lung Reactance at 5Hz (X5)
Time Frame: Intake assessment
Measurement of the ability of the lung to store energy, as measured by oscillometry
Baseline Oxygen Saturation (SpO2)
Time Frame: Intake assessment
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Change from Baseline Oxygen Saturation (SpO2) at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Change from Baseline FEV1/FVC Ratio each day
Time Frame: Daily through study completion, an average of 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
Change from Baseline Oxygen Saturation (SpO2) at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Baseline Fractional Exhaled Nitric Oxide (FeNO)
Time Frame: Intake assessment
Amount of nitric oxide in the breath
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
Amount of nitric oxide in the breath
Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
Airway impedence in the lungs as measured by oscillometry
Change from Baseline Oxygen Saturation (SpO2) each day
Time Frame: Daily through study completion, an average of 4 weeks
Amount of oxygen carried in the blood as a percentage of the normal maximum, as assessed via pulse oximetry
Baseline St. George's Respiratory Questionnaire for COPD Patients Score
Time Frame: Intake assessment
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
Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
Measurement of the ability of the lung to store energy, as measured by oscillometry
Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
Measurement of the ability of the lung to store energy, as measured by oscillometry
Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
Amount of nitric oxide in the breath
Baseline COPD Assessment Test Score
Time Frame: Intake assessment
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline COPD Assessment Test Score at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline COPD Assessment Test Score at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
Score measuring the impact of COPD on an individual's life; scale of 0-40; higher score indicates worse outcome
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks
Time Frame: Assessment completed 2 weeks after intake assessment
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
Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks
Time Frame: Assessment completed 4 weeks after intake assessment
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
Secondary Outcomes
- Baseline Heart Rate(Intake assessment)
- Change From Baseline Heart Rate at 4 weeks(Assessment completed 4 weeks after intake assessment)
- Baseline Blood Pressure(Intake assessment)
- Change from Baseline Heart Rate each day(Daily through study completion, an average of 4 weeks)
- Change from Baseline Blood Pressure at 4 weeks(Assessment completed 4 weeks after intake assessment)
- Change From Baseline Heart Rate at 2 weeks(Assessment completed 2 weeks after 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)
Investigators
Diann Gaalema
Associate Professor, Department of Psychiatry
University of Vermont