COPDNCT03379025
Effects of Electronic Cigarettes in Cigarette Smokers With Mild to Moderate COPD
A study testing Electronic cigarette in people with COPD and Tobacco Use, run by Massachusetts General Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Tobacco Use
- What is being tested?
- Electronic cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Tobacco Use
- Being tested
- Electronic cigarette
- Keywords
- electronic cigarettes; e-cigarettes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Tobacco Use, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic cigaretteOther
Also called e-cigarette, JUUL electronic cigarette
electronic cigarette and cartridge refills (also known as pods)
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention Group | Experimental | JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks Receives: 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 Receives: Other: Electronic cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarettes per day
Change in self-reported cigarettes per day from Week 0 to Week 12
Measured: baseline and 12 weeks
Secondary outcomes (6)
Change in urine anabasine
Change in tobacco biomarker anabasine from Week 0 to Week 12
Measured: baseline and 12 weeks
Change in urine cotinine
Change in nicotine metabolite cotinine from Week 0 to Week 12
Measured: baseline and 12 weeks
Change in exhaled carbon monoxide
Change in exhaled carbon monoxide from Week 0 to Week 12
Measured: 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
Measured: baseline and 12 weeks
Transition Dyspnea Index
Change in Transition Dyspnea Index at Week 12 from the Baseline Dyspnea Index at Week 0
Measured: 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
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study startOct 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: did not start RCT due to current concerns about vaping-related lung illness
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Kalkhoran, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379025
- Sponsor's protocol ID
- 2017P002418
- Status last verified
- Nov 2019
- First submitted
- 8 Dec 2017
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electronic Cigarettes on Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03379025
- Acronym / sponsor ID
- 2017P002418
- Conditions
- COPD, Tobacco Use
- Keywords
- electronic cigarettes; e-cigarettes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: did not start RCT due to current concerns about vaping-related lung illness
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention Group | Experimental | Other: Electronic cigaretteJUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks |
| Delayed Intervention Group | Other | Other: Electronic cigaretteAfter 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic cigaretteAlso: e-cigarette, JUUL electronic cigaretteelectronic cigarette and cartridge refills (also known as pods) | Other | Delayed Intervention Group, Early Intervention Group |
Primary outcome
Change in cigarettes per day
Time frame: baseline and 12 weeks
Change in self-reported cigarettes per day from Week 0 to Week 12
6 secondary outcomes
Change in urine anabasine
Time frame: baseline and 12 weeks
Change in urine cotinine
Time frame: baseline and 12 weeks
Change in exhaled carbon monoxide
Time frame: baseline and 12 weeks
Change in pulmonary function
Time frame: baseline and 12 weeks
Transition Dyspnea Index
Time frame: baseline and 12 weeks
St. George's Respiratory Questionnaire
Time frame: baseline and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic cigarette in people with COPD and Tobacco Use, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cigarettes per day (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.