An interventional study of Electronic cigarette in COPD and Tobacco Use, sponsored by Massachusetts General Hospital. Withdrawn. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-06.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Other
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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.
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.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →Massachusetts General Hospital is the lead sponsor of 2,588 studies on the registry; 446 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks
Other: 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
Other: Electronic cigarette
electronic cigarette and cartridge refills (also known as pods)
Also known as: e-cigarette, JUUL electronic cigarette
Change in cigarettes per day
Change in self-reported cigarettes per day from Week 0 to Week 12
Time frame: baseline and 12 weeks
Change in urine anabasine
Change in tobacco biomarker anabasine from Week 0 to Week 12
Time frame: baseline and 12 weeks
Change in urine cotinine
Change in nicotine metabolite cotinine from Week 0 to Week 12
Time frame: baseline and 12 weeks
Change in exhaled carbon monoxide
Change in exhaled carbon monoxide from Week 0 to Week 12
Time frame: 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
Time frame: baseline and 12 weeks
Transition Dyspnea Index
Change in Transition Dyspnea Index at Week 12 from the Baseline Dyspnea Index at Week 0
Time frame: 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
Time frame: baseline and 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks and 24 weeks for immediate intervention group; 24 weeks and 36 weeks for delayed intervention group
No study locations are listed for this record.
Start is estimated for Oct 2019; primary completion for Apr 2021, 18 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Massachusetts General Hospital →