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

November 4, 2019 updated by: Sara Kalkhoran, Massachusetts General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cigarettes per day
Time Frame: baseline and 12 weeks
Change in self-reported cigarettes per day from Week 0 to Week 12
baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in urine anabasine
Time Frame: baseline and 12 weeks
Change in tobacco biomarker anabasine from Week 0 to Week 12
baseline and 12 weeks
Change in urine cotinine
Time Frame: baseline and 12 weeks
Change in nicotine metabolite cotinine from Week 0 to Week 12
baseline and 12 weeks
Change in exhaled carbon monoxide
Time Frame: baseline and 12 weeks
Change in exhaled carbon monoxide from Week 0 to Week 12
baseline and 12 weeks
Change in pulmonary function
Time Frame: baseline and 12 weeks
Change in post-bronchodilator forced expiratory volume in one second (FEV1) from Week 0 to Week 12
baseline and 12 weeks
Transition Dyspnea Index
Time Frame: baseline and 12 weeks
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
Time Frame: baseline and 12 weeks
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sustained change in cigarettes per day
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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
Time Frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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