An interventional study of THS use and Cigarette in COPD, Smoking and Tobacco Use, sponsored by Philip Morris Products S.A.. Terminated at 170 sites in 8 countries. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Philip Morris Products S.A. (part of Philip Morris International) · Not applicable, Interventional, and Other
The purpose of this study is to demonstrate the slowing of the disease progression including the improvement of Chronic Obstructive Pulmonary Disease (COPD) symptoms in smoking subjects with mild to moderate COPD and a history of chronic bronchitis symptoms (sputum and cough) who switch to the Tobacco Heating System (THS) as compared to those who continue to smoke cigarettes.
This study will be a multiregional (Europe, U.S., and Asia) multi-center, open-label study with 3-group, parallel preference design (Cigarette, THS use, and Smoking Abstinence).
Subjects will self-select their group allocation according to their preference. Subjects who would like to quit cigarettes or THS during the study will be encouraged to do so and will be referred to appropriate services.
The study will be declared successful if a slowing of the disease progression is demonstrated with the primary objective endpoint of forced expiratory volume in the first second (FEV1) post-bronchodilator at Month 36 or if an improvement of COPD symptoms (COPD Assessment Test total score at interim analysis at Month 12) is demonstrated.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 715 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Philip Morris Products S.A. is the lead sponsor of 49 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Subjects who are not willing to quit smoking.
Other: THS use
Subjects who are not willing to quit smoking.
Other: Cigarette
Subjects who are willing to quit smoking.
Other: Smoking Abstinence
Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS
Also known as: Tobacco Heating System 3.0
Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
Subjects who are willing to quit smoking may be prescribed an NRT to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)
Disease Progression
Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator
Time frame: At month 36
COPD symptoms
COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).
Time frame: At month 12
Showing the first 100 of 170 sites across 8 countries.
Ran from Dec 2022 to primary completion in Sep 2024, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →