RECRUITING

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.

Official Title

A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)

Quick Facts

Study Start:2025-04-02

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07108166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adult, both sexes, aged ≥ 40 years. * Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval. * Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or \> 40 kg (female). Checked at V1 and V2. * Patient has a CIG smoking history ≥ 10 years. * Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V2. * Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2. * Patient agrees to be randomized into one of the two study arms. Checked at V2. * Patient with confirmed COPD via spirometry (FEV1/FVC \< 70%, postbronchodilator (-BD)) with presence of chronic bronchitis (cough and mucus most of the days for \> three months a year for the previous two years in a row) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30% ≤ FEV1 \< 80% predicted, -BD). * Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2.	* Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year. * Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2. * Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin. * Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2. * Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V2. * Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read). * Patient with a history of asthma. * Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse). * Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives. * Patient with active or history of alcohol and/or drug abuse within the past year. * Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C). * Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study. * Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion. * Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation. * Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2. * Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months. * Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2. * Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.

Inclusion Criteria

Exclusion Criteria

* Adult, both sexes, aged ≥ 40 years.
* Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.
* Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or \> 40 kg (female). Checked at V1 and V2.
* Patient has a CIG smoking history ≥ 10 years.
* Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V2.
* Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2.
* Patient agrees to be randomized into one of the two study arms. Checked at V2.
* Patient with confirmed COPD via spirometry (FEV1/FVC \< 70%, postbronchodilator (-BD)) with presence of chronic bronchitis (cough and mucus most of the days for \> three months a year for the previous two years in a row) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30% ≤ FEV1 \< 80% predicted, -BD).
* Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2.

* Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.
* Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2.
* Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin.
* Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2.
* Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V2.
* Patient is legally incompetent, physically, and/or mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read).
* Patient with a history of asthma.
* Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse).
* Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives.
* Patient with active or history of alcohol and/or drug abuse within the past year.
* Patient with positive serological tests for human immunodeficiency virus (HIV) 1/2, hepatitis B or C (Hep B/C).
* Patient with any concomitant issues (e.g., medical, psychiatric, and/or social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study.
* Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion.
* Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation.
* Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2.
* Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months.
* Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2.
* Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.

Contacts and Locations

Study Contact

Xavier Jaumont, MD

CONTACT

+41582421111

Xavier.Jaumont@pmi.com

Principal Investigator

Xavier Jaumont, MD

STUDY_CHAIR

Philip Morris Products S.A.

Study Locations (Sites)

Florida International Medical Research

Coral Gables, Florida, 33134

United States

Gabriela Marinello (Beautiful Minds)

Cutler Bay, Florida, 33157

United States

Alfa Medical Research

Davie, Florida, 33024

United States

Omega Research Debary, LLC

DeBary, Florida, 32713

United States

D&H Doral Research Center

Doral, Florida, 33122

United States

Felicidad Med Research

Hialeah, Florida, 33012

United States

D&H Pompano Research Center

Margate, Florida, 33063

United States

San Marcus Research

Miami Lakes, Florida, 33015

United States

MedQuest Translational Sciences LLC

Miami Lakes, Florida, 33016

United States

Med-Care Research Corp

Miami, Florida, 33125

United States

D&H National Research Centers- Miami

Miami, Florida, 33155

United States

Global Health Clinical Trials Corp.

Miami, Florida, 33165

United States

Harmony Clinical Research

North Miami Beach, Florida, 33162

United States

D&H Tamarac Research Center

Tamarac, Florida, 33321

United States

Palm Beach Research Center

West Palm Beach, Florida, 33409

United States

ClinCept - Columbus (ClinCept, LLC)

Columbus, Georgia, 31904

United States

Pivotal Research Solutions

Stonecrest, Georgia, 30038

United States

Prolato Research LLC.

Houston, Texas, 77054

United States

Clinical Trial Network, LLC

Houston, Texas, 77074

United States

Accurate Clinical Research, Inc.

Humble, Texas, 77338

United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas, 75069

United States

Element Research Group

San Antonio, Texas, 78258

United States

Collaborators and Investigators

Sponsor: Philip Morris Products S.A.

Xavier Jaumont, MD, STUDY_CHAIR, Philip Morris Products S.A.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-02

Study Completion Date2026-11

Study Record Updates

Study Start Date2025-04-02

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

COPD
Smoking
Tobacco Use