Asthma-COPD Overlap Syndrome, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Emphysema
Conditions
Keywords
chronic obstructive pulmonary disease, pulmonary, cardiac, cigarettes, e-cigarettes, smokers
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.
Interventions
OTHERE-Cigarette
Altering the availability of e-cigarettes
BEHAVIORALFinancial Incentives
Altering the availability of financial incentives for abstaining from combustible cigarettes
Sponsors
National Institute on Drug Abuse (NIDA)
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline FEV1/FVC Ratio | 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 each day | 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 FEV1/FVC Ratio at 2 weeks | 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 |
| Change from Baseline FEV1/FVC Ratio at 4 weeks | 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) | 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 2 weeks | 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 | Assessment completed 4 weeks after intake assessment | Measurement of the ability of the lung to store energy, as measured by oscillometry |
| Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) | Intake assessment | Airway impedence in the lungs as measured by oscillometry |
| Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks | Assessment completed 2 weeks after 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 | Assessment completed 4 weeks after intake assessment | Airway impedence in the lungs as measured by oscillometry |
| Baseline Oxygen Saturation (SpO2) | 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) each day | 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 |
| Change from Baseline Oxygen Saturation (SpO2) at 2 weeks | 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 |
| Change from Baseline Oxygen Saturation (SpO2) at 4 weeks | 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 |
| Baseline Fractional Exhaled Nitric Oxide (FeNO) | Intake assessment | Amount of nitric oxide in the breath |
| Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks | Assessment completed 2 weeks after intake assessment | Amount of nitric oxide in the breath |
| Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks | Assessment completed 4 weeks after intake assessment | Amount of nitric oxide in the breath |
| Baseline COPD Assessment Test Score | 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 | 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 | 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 |
| Baseline St. George's Respiratory Questionnaire for COPD Patients Score | 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 2 weeks | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Heart Rate at 4 weeks | Assessment completed 4 weeks after intake assessment | Number of time the heart beats per minute |
| Baseline Blood Pressure | Intake assessment | Force exerted by blood against the walls of the arteries |
| Change from Baseline Blood Pressure each day | Daily through study completion, an average of 4 weeks | Force exerted by blood against the walls of the arteries |
| Change from Baseline Blood Pressure at 2 weeks | Assessment completed 2 weeks after intake assessment | Force exerted by blood against the walls of the arteries |
| Change from Baseline Blood Pressure at 4 weeks | Assessment completed 4 weeks after intake assessment | Force exerted by blood against the walls of the arteries |
| Baseline Heart Rate | Intake assessment | Number of time the heart beats per minute |
| Change from Baseline Heart Rate each day | Daily through study completion, an average of 4 weeks | Number of time the heart beats per minute |
| Change From Baseline Heart Rate at 2 weeks | Assessment completed 2 weeks after intake assessment | Number of time the heart beats per minute |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks | Assessment completed 2 weeks after intake assessment | Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome |
| Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks | Assessment completed 4 weeks after intake assessment | Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome |
| Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) | Intake assessment | Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke |
| Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks | Assessment completed 2 weeks after intake assessment | Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke |
| Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks | Assessment completed 4 weeks after intake assessment | Assesses smoking urges; scale of 10-70; higher scores indicate greater urge to smoke |
| Daily Tobacco Use Questionnaire | Daily during each two-week arm of the study | Measure tobacco use (cigarettes, e-cigarettes, smokeless tobacco) on a daily basis; |
| Health Changes Questionnaire at 2 week assessment | Assessment completed 2 weeks after intake assessment | Assesses how health has changed since previous visit; 4 yes/no questions about whether there have been any changes in physical/mental health, changes in medications, access to medical care, or changes in normal routine in the last 24 hours; 1 question rating overall health on a scale of 1 to 10 with 10 being the best |
| Health Changes Questionnaire at 4 week assessment | Assessment completed 4 weeks after intake assessment | Assesses how health has changed since previous visit; 4 yes/no questions about whether there have been any changes in physical/mental health, changes in medications, access to medical care, or changes in normal routine in the last 24 hours; 1 question rating overall health on a scale of 1 to 10 with 10 being the best |
| Baseline Carbon Monoxide (CO) | Intake assessment | Amount of carbon monoxide in the breath |
| Change from Baseline Carbon Monoxide (CO) each day | Daily through study completion, an average of 4 weeks | Amount of carbon monoxide in the breath |
| Change from Baseline Carbon Monoxide (CO) at 2 weeks | Assessment completed 2 weeks after intake assessment | Amount of carbon monoxide in the breath |
| Change from Baseline Carbon Monoxide (CO) at 4 weeks | Assessment completed 4 weeks after intake assessment | Amount of carbon monoxide in the breath |
| Baseline Tobacco Use Questionnaire | Intake assessment | Assess tobacco use history |
| Baseline Fagerstrom Test of Nicotine Dependence (FTND) | Intake assessment | Survey assessing addiction to nicotine |
| Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief) | Intake assessment | Survey assessing smoking dependence |
| Baseline Minnesota Tobacco Withdrawal Scale (MNWS) | Intake assessment | Evaluates effects of smoking cessation; scale of 0-60; higher scores are a worse outcome |
Countries
United States
Outcome results
None listed