Clinical trial NCT03379025: Effects of Electronic Cigarettes in Cigarette Smokers With Mild to Moderate COPD
Official title: Effects of Electronic Cigarettes on Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COPD
Tobacco Use
Keywords: electronic cigarettes; e-cigarettes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cigarettes per day
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in urine anabasine
timeFrame: baseline and 12 weeks
measure: Change in urine cotinine
timeFrame: baseline and 12 weeks
measure: Change in exhaled carbon monoxide
timeFrame: baseline and 12 weeks
measure: Change in pulmonary function
timeFrame: baseline and 12 weeks
measure: Transition Dyspnea Index
timeFrame: baseline and 12 weeks
measure: St. George's Respiratory Questionnaire
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Sustained change in cigarettes per day
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
measure: Sustained change in urine anabasine
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
measure: Sustained change in urine cotinine
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
measure: Sustained change in exhaled carbon monoxide
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
measure: Sustained change in pulmonary function
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
measure: Sustained change in transition dyspnea index
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
measure: Sustained change in St. George's Respiratory Questionnaire
timeFrame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
Locations:
Study officials:
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