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Behavioural Intervention

Switching to THS for COPD

Verified Trial
N/A
Recruiting
Research Sponsored by Philip Morris Products S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects have read, understood, and signed the written informed consent form (ICF)
Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC <0.7 & FEV1 ≥60% predicted [post-BD])
Must not have
Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1
Subjects with other active respiratory disorders: tuberculosis, lung cancer, bronchiectasis, sarcoidosis, asthma, pulmonary hypertension, interstitial lung diseases
Timeline
Screening 1 day
Treatment 36 months
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial studies if switching from cigarettes to a Tobacco Heating System can slow COPD symptom progression and improve symptoms in smokers with mild-moderate COPD.

Who is the study for?
This trial is for adults with mild to moderate COPD and chronic bronchitis symptoms who have been smoking at least 10 cigarettes a day for over a year. They must not be using other tobacco products or willing to quit smoking, with no recent use of THS or participation in other studies. Pregnant women and individuals with other respiratory disorders are excluded.
What is being tested?
The study aims to see if switching from cigarette smoking to using the Tobacco Heating System (THS) can slow down COPD progression compared to those who continue smoking. Participants will either switch to THS, maintain their regular smoking habits, or attempt total smoking abstinence.
What are the potential side effects?
While specific side effects aren't listed here, generally switching from cigarettes could lead to nicotine withdrawal symptoms such as cravings, irritability, and difficulty concentrating. The long-term effects of THS use are still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mild to moderate COPD based on my lung function tests.
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I have had chronic bronchitis symptoms for the past year.
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I have been smoking for at least 10 years.
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I have only used cigarettes, not other tobacco or nicotine products, daily for the last year.
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I have had chronic bronchitis symptoms for the past year.
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My COPD is in the early stages (Stage 1 or 2).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active lung problems like TB, lung cancer, or asthma.

Timeline

Screening ~ 1 day
Treatment ~ 36 months
Follow Up ~3 months
This trial's timeline: 1 day for screening, 36 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
COPD symptoms
Disease Progression

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: THSActive Control1 Intervention
Subjects who are not willing to quit smoking.
Group II: CigaretteActive Control1 Intervention
Subjects who are not willing to quit smoking.
Group III: Smoking AbstinenceActive Control1 Intervention
Subjects who are willing to quit smoking.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Philip Morris Products S.A.Lead Sponsor
46 Previous Clinical Trials
30,007 Total Patients Enrolled
Christelle Haziza, PhDStudy ChairPhilip Morris Products S.A.
27 Previous Clinical Trials
5,583 Total Patients Enrolled

Media Library

Smoking Abstinence (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05569005 — N/A
Chronic Obstructive Pulmonary Disease Research Study Groups: THS, Cigarette, Smoking Abstinence
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Smoking Abstinence Highlights & Side Effects. Trial Name: NCT05569005 — N/A
Smoking Abstinence (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05569005 — N/A
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05569005 — N/A
~533 spots leftby Sep 2025
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