Effects of Electronic Cigarettes in Cigarette Smokers With Mild to Moderate COPD

Study Overview
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Brief Summary
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This study evaluates the effects of electronic cigarette use on cigarette smoking and markers of tobacco use, as well as respiratory symptoms and function in smokers with mild to moderate chronic obstructive pulmonary disease (COPD). All participants will receive a 12 week supply of electronic cigarettes to use instead of their regular conventional cigarettes.

Detailed Description
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Electronic cigarettes are devices that heat a solution containing nicotine to form an aerosol that is then inhaled by the user. Electronic cigarettes are used by many smokers, including smokers with chronic health conditions such as COPD. Given that e-cigarettes are still relatively new, their effects on health are not well defined. It is important to understand how electronic cigarettes affects symptoms and lung function in smokers with COPD to determine the short-term safety of these products. To do this, an initial step involves observing the extent to which smokers substitute their conventional cigarette use with electronic cigarette use and change their exposure to tobacco use biomarkers.

Official Title
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Effects of Electronic Cigarettes on Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease

Conditions
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COPD, Tobacco Use

Intervention / Treatment
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* Other: Electronic cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 10 pack year smoking history Daily use of at least 5 cigarettes No plan to quit cigarettes in the next 30 days Willing to use e-cigarettes Diagnosis of COPD (FEV1/forced vital capacity [FVC] <0.70) with mild (FEV1 >80% predicted) or moderate (FEV1 <80% but >50% predicted) airflow limitation (post-bronchodilator); confirmed by spirometry English-speaking Exclusion Criteria: Past 30-day use of nicotine-containing products (cigars, cigarillos, hookah, electronic cigarettes, smokeless tobacco, nicotine replacement therapy) Past 30 day use of inhaled drugs (marijuana, crack) Pregnant or breastfeeding Planning to become pregnant within the next 3 months or unable to agree to use appropriate contraception during study Pulmonary disease other than COPD or asthma Ever requiring mechanical ventilation 2 or more hospitalizations for COPD in the past 12 months Cardiac hospitalization in the past 6 months Active chest pain or palpitations Uncontrolled hypertension (blood pressure >160/100) Oxygen therapy Inability or contraindication to perform spirometry (e.g. recent eye, thoracic, or abdominal surgery) Known allergy to propylene glycol or vegetable glycerin Unable to consent or complete assessments

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention Group<br>JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks | Other: Electronic cigarette<br>* electronic cigarette and cartridge refills (also known as pods)<br>* Other names: e-cigarette, JUUL electronic cigarette;|
| Other: Delayed Intervention Group<br>After a 12 week period of no electronic cigarette use, JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks | Other: Electronic cigarette<br>* electronic cigarette and cartridge refills (also known as pods)<br>* Other names: e-cigarette, JUUL electronic cigarette;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cigarettes per day | Change in self-reported cigarettes per day from Week 0 to Week 12 | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urine anabasine | Change in tobacco biomarker anabasine from Week 0 to Week 12 | baseline and 12 weeks | 
| Change in urine cotinine | Change in nicotine metabolite cotinine from Week 0 to Week 12 | baseline and 12 weeks | 
| Change in exhaled carbon monoxide | Change in exhaled carbon monoxide from Week 0 to Week 12 | baseline and 12 weeks | 
| Change in pulmonary function | Change in post-bronchodilator forced expiratory volume in one second (FEV1) from Week 0 to Week 12 | baseline and 12 weeks | 
| Transition Dyspnea Index | Change in Transition Dyspnea Index at Week 12 from the Baseline Dyspnea Index at Week 0 | baseline and 12 weeks | 
| St. George's Respiratory Questionnaire | Change in quality of life as measured by the St. George's Respiratory Questionnaire from Week 0 to Week 12 | baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic cigarettes; e-cigarettes