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

NCT03379025 | Withdrawn DMC

• 1 other identifier: 2017P002418
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD; Tobacco Use

Keywords

electronic cigarettes; e-cigarettes

Outcome Measures

Primary Outcomes (1)

• Change in cigarettes per day

  Change in self-reported cigarettes per day from Week 0 to Week 12

  baseline and 12 weeks

Secondary Outcomes (6)

• Change in urine anabasine

  baseline and 12 weeks

• Change in urine cotinine

  baseline and 12 weeks

• Change in exhaled carbon monoxide

  baseline and 12 weeks

• Change in pulmonary function

  baseline and 12 weeks

• Transition Dyspnea Index

  baseline and 12 weeks

Other Outcomes (7)

• Sustained change in cigarettes per day

  12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group

• Sustained change in urine anabasine

  12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group

• Sustained change in urine cotinine

  12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group

Study Arms (2)

Early Intervention Group

EXPERIMENTAL

JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks

Other: Electronic cigarette

Delayed Intervention Group

OTHER

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

Interventions

Electronic cigarette OTHER

electronic cigarette and cartridge refills (also known as pods)

Also known as: e-cigarette, JUUL electronic cigarette

Delayed Intervention Group; Early Intervention Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Tobacco Use; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 20, 2017
• Study Start: October 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 6, 2019

Record last verified: 2019-11