Effects of Electronic Cigarettes in Cigarette Smokers With Mild to Moderate COPD

Effects of Electronic Cigarettes on Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Tobacco Use; COPD
• Intervention / Treatment: Other: Electronic cigarette

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early Intervention Group; JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks	Other: Electronic cigarette; electronic cigarette and cartridge refills (also known as pods); Other Names: e-cigarette, JUUL electronic cigarette
OTHER: Delayed Intervention Group; 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	Other: Electronic cigarette; electronic cigarette and cartridge refills (also known as pods); Other Names: e-cigarette, JUUL electronic cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: electronic cigarettes; e-cigarettes
• Other Study ID Numbers: 2017P002418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No