COPD, Tobacco Use
Conditions
Keywords
electronic cigarettes; e-cigarettes
Brief summary
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
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.
Interventions
OTHERElectronic cigarette
electronic cigarette and cartridge refills (also known as pods)
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cigarettes per day | baseline and 12 weeks | Change in self-reported cigarettes per day from Week 0 to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urine anabasine | baseline and 12 weeks | Change in tobacco biomarker anabasine from Week 0 to Week 12 |
| Change in urine cotinine | baseline and 12 weeks | Change in nicotine metabolite cotinine from Week 0 to Week 12 |
| Change in exhaled carbon monoxide | baseline and 12 weeks | Change in exhaled carbon monoxide from Week 0 to Week 12 |
| Change in pulmonary function | baseline and 12 weeks | Change in post-bronchodilator forced expiratory volume in one second (FEV1) from Week 0 to Week 12 |
| Transition Dyspnea Index | baseline and 12 weeks | Change in Transition Dyspnea Index at Week 12 from the Baseline Dyspnea Index at Week 0 |
| St. George's Respiratory Questionnaire | baseline and 12 weeks | Change in quality of life as measured by the St. George's Respiratory Questionnaire from Week 0 to Week 12 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sustained change in cigarettes per day | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in cigarettes per day after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| Sustained change in urine anabasine | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in urine anabasine after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| Sustained change in urine cotinine | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in urine cotinine after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| Sustained change in exhaled carbon monoxide | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in exhaled carbon monoxide after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| Sustained change in pulmonary function | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in post-bronchodilator FEV1 after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| Sustained change in transition dyspnea index | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in post-bronchodilator FEV1 after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| Sustained change in St. George's Respiratory Questionnaire | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group | Assess whether any changes in quality of life as measured by the St. George's Respiratory Questionnaire after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
Outcome results
None listed