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

Not Applicable

Withdrawn

• Conditions: COPD; Tobacco Use
• Interventions: Other: Electronic cigarette

• Registration Number: NCT03379025
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-20
• Study Start: 2019-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06
• Primary Completion: 2021-04
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Intervention Group	Electronic cigarette	JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks
Delayed Intervention Group	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

Primary Outcome Measures

Name	Time	Method
Change in cigarettes per day	baseline and 12 weeks	Change in self-reported cigarettes per day from Week 0 to Week 12

Secondary Outcome Measures

Name	Time	Method
St. George's Respiratory Questionnaire	baseline and 12 weeks	Change in quality of life as measured by the St. George's Respiratory Questionnaire from Week 0 to Week 12
Change in urine anabasine	baseline and 12 weeks	Change in tobacco biomarker anabasine from Week 0 to Week 12
Change in exhaled carbon monoxide	baseline and 12 weeks	Change in exhaled carbon monoxide from Week 0 to Week 12
Change in urine cotinine	baseline and 12 weeks	Change in nicotine metabolite cotinine from Week 0 to Week 12
Transition Dyspnea Index	baseline and 12 weeks	Change in Transition Dyspnea Index at Week 12 from the Baseline Dyspnea Index at Week 0
Change in pulmonary function	baseline and 12 weeks	Change in post-bronchodilator forced expiratory volume in one second (FEV1) from Week 0 to Week 12