Status:
WITHDRAWN
Effects of Electronic Cigarettes in Cigarette Smokers With Mild to Moderate COPD
Lead Sponsor:
Massachusetts General Hospital
Conditions:
COPD
Tobacco Use
Eligibility:
All Genders
40-80 years
Phase:
NA
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 obst...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03379025
Start Date
October 1 2019
End Date
August 1 2021
Last Update
November 6 2019
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