Effects of Electronic Cigarettes on Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease
| Registry | NCT03379025 |
|---|---|
| Status | Withdrawn - did not start RCT due to current concerns about vaping-related lung illness |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Sponsor | Massachusetts General Hospital (Other) |
| Conditions | COPD, Tobacco Use |
| Interventions | Electronic cigarette (Other) |
| Dates | start 2019-10-01 (estimated), primary completion 2021-04-01 (estimated), completion 2021-08-01 (estimated), first posted 2017-12-20, last updated 2019-11-06 |
Related Papers Related Patents Related Grants Related Experts
All trials for COPD All trials for Tobacco Use All trials of Electronic cigarette
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Early Intervention Group | Experimental | Other: Electronic cigarette | JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks |
| Delayed Intervention Group | Other | Other: Electronic cigarette | 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 |
Sex: All, ages: 40 Years to 80 Years
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