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did not start RCT due to current concerns about vaping-related lung illness
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intervention Group | Experimental | JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks |
|
| Delayed Intervention Group | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic cigarette | Other | electronic cigarette and cartridge refills (also known as pods) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained change in cigarettes per day | Assess whether any changes in cigarettes per day after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| Sustained change in urine anabasine |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D064424 | Tobacco Use |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| 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 |
Assess whether any changes in urine anabasine after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks |
| 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| Sustained change in urine cotinine | Assess whether any changes in urine cotinine after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| Sustained change in exhaled carbon monoxide | Assess whether any changes in exhaled carbon monoxide after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| Sustained change in pulmonary function | Assess whether any changes in post-bronchodilator FEV1 after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| Sustained change in transition dyspnea index | Assess whether any changes in post-bronchodilator FEV1 after 12 weeks of receiving e-cigarettes are sustained after an additional 12 weeks | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| Sustained change in St. George's Respiratory Questionnaire | 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 | 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D012907 | Smoking |