Clinical trial NCT05610514: Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Official title: Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Asthma-COPD Overlap Syndrome
Keywords: chronic obstructive pulmonary disease
pulmonary
cardiac
cigarettes
e-cigarettes
smokers
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-11-09
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline FEV1/FVC Ratio
timeFrame: Intake assessment
measure: Change from Baseline FEV1/FVC Ratio each day
timeFrame: Daily through study completion, an average of 4 weeks
measure: Change from Baseline FEV1/FVC Ratio at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline FEV1/FVC Ratio at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Lung Reactance at 5Hz (X5)
timeFrame: Intake assessment
measure: Change from Baseline Lung Reactance at 5Hz (X5) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Lung Reactance at 5Hz (X5) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19)
timeFrame: Intake assessment
measure: Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Lung Resistance at 5Hz and 19Hz (R5 and R19) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Oxygen Saturation (SpO2)
timeFrame: Intake assessment
measure: Change from Baseline Oxygen Saturation (SpO2) each day
timeFrame: Daily through study completion, an average of 4 weeks
measure: Change from Baseline Oxygen Saturation (SpO2) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Oxygen Saturation (SpO2) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Intake assessment
measure: Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change From Baseline Fractional Exhaled Nitric Oxide (FeNO) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline COPD Assessment Test Score
timeFrame: Intake assessment
measure: Change from Baseline COPD Assessment Test Score at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline COPD Assessment Test Score at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline St. George's Respiratory Questionnaire for COPD Patients Score
timeFrame: Intake assessment
measure: Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline St. George's Respiratory Questionnaire for COPD Patients Score at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
Secondary outcomes:
measure: Baseline Blood Pressure
timeFrame: Intake assessment
measure: Change from Baseline Blood Pressure each day
timeFrame: Daily through study completion, an average of 4 weeks
measure: Change from Baseline Blood Pressure at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Blood Pressure at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Heart Rate
timeFrame: Intake assessment
measure: Change from Baseline Heart Rate each day
timeFrame: Daily through study completion, an average of 4 weeks
measure: Change From Baseline Heart Rate at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change From Baseline Heart Rate at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
Other outcomes:
measure: Baseline Carbon Monoxide (CO)
timeFrame: Intake assessment
measure: Change from Baseline Carbon Monoxide (CO) each day
timeFrame: Daily through study completion, an average of 4 weeks
measure: Change from Baseline Carbon Monoxide (CO) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Carbon Monoxide (CO) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Tobacco Use Questionnaire
timeFrame: Intake assessment
measure: Baseline Fagerstrom Test of Nicotine Dependence (FTND)
timeFrame: Intake assessment
measure: Baseline Wisconsin Inventory of Smoking Dependence Motives - Brief (WISDM-Brief)
timeFrame: Intake assessment
measure: Baseline Minnesota Tobacco Withdrawal Scale (MNWS)
timeFrame: Intake assessment
measure: Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Minnesota Tobacco Withdrawal Scale (MNWS) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief)
timeFrame: Intake assessment
measure: Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 2 weeks
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Change from Baseline Questionnaire on Smoking Urges-Brief (QSU-Brief) at 4 weeks
timeFrame: Assessment completed 4 weeks after intake assessment
measure: Daily Tobacco Use Questionnaire
timeFrame: Daily during each two-week arm of the study
measure: Health Changes Questionnaire at 2 week assessment
timeFrame: Assessment completed 2 weeks after intake assessment
measure: Health Changes Questionnaire at 4 week assessment
timeFrame: Assessment completed 4 weeks after intake assessment
Locations:
city: Burlington
country: United States
facility: Vermont Center on Behavior and Health
state: Vermont
Study officials:
affiliation: University of Vermont
name: Diann E Gaalema, PhD
role: PRINCIPAL_INVESTIGATOR
References: