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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 6 months
Follow Up 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 ~ 6 months
Follow Up ~3 months
This trial's timeline: 1 day for screening, 6 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
COPD symptoms
Disease Progression

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
29,988 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial allow for participants under 45 years of age?

"This trial is limited to patients aged 40-65 years old. However, individuals outside of this age range can access 38 studies for those under 18 and 425 trials for seniors beyond the age of 65."

Answered by AI

Are there a plethora of Canadian medical facilities conducting this research endeavor?

"Presently, 65 medical sites across Clearwater, Lakeland and Largo are recruiting for this research project. It would be beneficial to choose the clinic nearest you in order to reduce your travel burden if you become a trial participant."

Answered by AI

What is the aggregate number of participants in this trial?

"Confirmed. According to the information displayed on clinicaltrials.gov, this study is actively looking for participants and was initially posted December 16th 2022. The trial will include 1895 individuals being recruited from 65 different medical sites."

Answered by AI

Is enrollment open presently for this experiment?

"Affirmative. Clinicaltrials.gov corroborates that the research is actively searching for 1895 participants to be recruited from 65 different medical facilities. This initiative was initially posted on December 16th 2022 and most recently updated Jun 20th 2023."

Answered by AI

What criteria must be fulfilled in order to qualify for participation in this experiment?

"In order to be included in the trial, individuals must have chronic obstructive pulmonary disease and should lie within a 40-65 age range. Altogether, 1895 patients are desired for this research."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Texas
What site did they apply to?
US12; Leesburg Medical Research Institute, LLC
US73; Victorium Clinical Research
US53; Alpha Research Institute, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0

Why did patients apply to this trial?

I wish to recover my breath if possible. I have been smoking for over 25 years. I’ll try anything. To stop.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.
2022. "Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05569005.
All > Frisco
~947 spots leftby Sep 2025
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