Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
NCT ID: NCT07108166
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
290 participants
INTERVENTIONAL
2025-04-02
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cigarette
Cigarette
COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
THS
THS
COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.
Interventions
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Cigarette
COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
THS
COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions.
Eligibility Criteria
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Inclusion Criteria
* 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 performed at V1 (FEV1/FVC \<70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 \< 80% predicted, -BD) with presence of chronic bronchitis (cough and mucus most of the days for \> three months a year for the two consecutive years prior to the screening visit). Checked at V2.
* Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2. (Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the local time zone of the site where the patient is assessed.)
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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Philip Morris Products S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Xavier Jaumont, MD
Role: STUDY_CHAIR
Philip Morris Products S.A.
Locations
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Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Florida International Medical Research
Coral Gables, Florida, United States
Alfa Medical Research
Davie, Florida, United States
Omega Research Debary, LLC
DeBary, Florida, United States
D&H Doral Research Center
Doral, Florida, United States
Felicidad Med Research
Hialeah, Florida, United States
The Medici Medical Research, LLC
Hollywood, Florida, United States
D&H Pompano Research Center
Margate, Florida, United States
Med-Care Research Corp
Miami, Florida, United States
EMDA Clincal Research
Miami, Florida, United States
Sones Medical Research
Miami, Florida, United States
Suncoast Research Group, LLC dba Flourish Research
Miami, Florida, United States
Melgar-Caro Medcenter and Community Research
Miami, Florida, United States
D&H National Research Center- Miami
Miami, Florida, United States
Biomed Research & Medical Center.Llc
Miami, Florida, United States
Global Health Clinical Trials Corp.
Miami, Florida, United States
Professional Research Center Inc
Miami, Florida, United States
Newgen Health Group
Miami, Florida, United States
Reserka LLC
Miami, Florida, United States
Pharma Medical Innovations
Miami Lakes, Florida, United States
San Marcus Research
Miami Lakes, Florida, United States
MedQuest Translational Sciences LLC
Miami Lakes, Florida, United States
Advanced Research Institute, Inc
New Port Richey, Florida, United States
Harmony Clinical Research
North Miami Beach, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Comprehensive Medical & Research Center
Plantation, Florida, United States
CDC Research Institute
Port Saint Lucie, Florida, United States
Treasure Coast Medical Research Group
Port Saint Lucie, Florida, United States
Advanced Research Institute, Inc
St. Petersburg, Florida, United States
D&H Tamarac Research Center
Tamarac, Florida, United States
Metropolitan Clinical Research Center
Tamarac, Florida, United States
Optimum Clinical Trial Group
Tampa, Florida, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, United States
El Paso Pulmonary Association
El Paso, Texas, United States
HDH Research Inc
Houston, Texas, United States
Prolato Research LLC.
Houston, Texas, United States
Houston Pulmonary Medicine Associates
Houston, Texas, United States
Pioneer Research Solutions Inc
Houston, Texas, United States
Accurate Clinical Research, Inc.
Humble, Texas, United States
Metroplex Pulmonary & Sleep Center
McKinney, Texas, United States
Element Research Group
San Antonio, Texas, United States
Medrasa Clinical Research
Sherman, Texas, United States
Pulmonics Plus
Waxahachie, Texas, United States
MHAT Rahila Angelova
Pernik, , Bulgaria
MHAT Lyulin EAD
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Medical Center Pulmovision Ltd
Sofia, , Bulgaria
SHATPD Dr. Treyman
Veliko Tarnovo, , Bulgaria
SHATPPD Vratsa
Vratsa, , Bulgaria
MUDr. Otakar Hokynar - plicni ambulance
Kralupy nad Vltavou, , Czechia
Ordinace pro tbc a respirační nemoci s.r.o.
Olomouc, , Czechia
CCR Ostrava s.r.o.
Ostrava, , Czechia
Medicon a.s.
Prague, , Czechia
Prvni plicni ambulance s.r.o.
Prague, , Czechia
Pneumologie Varnsdorf s.r.o.
Varnsdorf, , Czechia
Klinische Forschung Berlin Mitte /Pratia Germany
Berlin, , Germany
Research Center for Medical Studies
Berlin, , Germany
Klifeck GmbH
Delitzsch, , Germany
Klinische Forschung Hannover-Mitte GmbH /Pratia Germany
Hanover, , Germany
Klinische Forschung Karlsruhe GmbH / Pratio Germany
Karlsruhe, , Germany
Facharzt für Innere Medizin und Pneumologie
Leipzig, , Germany
POIS Sachsen GmbH
Leipzig, , Germany
Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH
Neu-Isenburg, , Germany
FutureMeds Frankfurt
Offenbach, , Germany
Praxis Reinfeld Mitte
Reinfeld, , Germany
Siteworks - Prüfzentrum Schleswig | RespiRatio
Schleswig, , Germany
BAG Peter Fried / Dr. med. Roman Rubin
Wiesbaden, , Germany
Velocity Clinical Research Wiesbaden
Wiesbaden, , Germany
Lungenpraxis Witten
Witten, , Germany
Soejima Clinic
Fukuoka, , Japan
JCHO Nihonmatsu Hospital
Fukushima, , Japan
Maebashi North Hospital
Gunma, , Japan
Akashi Medical Center
Hyōgo, , Japan
Fukuwa Clinic
Tokyo, , Japan
Kouwa Clinic
Tokyo, , Japan
Sanyuudo Hospital
Yamagata, , Japan
Yokohama Minoru Clinic
Yokohama, , Japan
Clinical Research Hospital Tokyo
Yotsuya, , Japan
Centrum Medycyny Oddechowej Mroz Spolka jawna
Bialystok, , Poland
BioResearch Group Sp. z.o.o
Kajetany, , Poland
FutureMeds Krakowskie Centrum Medyczne
Krakow, , Poland
FutureMeds Łódź
Lodz, , Poland
AmiCare Centrum Medyczne
Lodz, , Poland
RCMed Oddział Sochaczew
Sochaczew, , Poland
FutureMeds Warszawa Centrum
Warsaw, , Poland
FutureMeds Targówek
Warsaw, , Poland
Dobrostan
Wroclaw, , Poland
FutureMeds Wrocław
Wroclaw, , Poland
Ames Research Center
Bragadiru, , Romania
Sc. Centrul Medical Sana Srl
Brasov, , Romania
Sana Medical Center
Bucharest, , Romania
Ames Research Center
Călăraşi, , Romania
Clintrial Medical Centre SRL
Dobrosloveni, , Romania
Spital de Pneumologie dr Lavinia Davidescu Oradea
Oradea, , Romania
AI Clinical Research
Sibiu, , Romania
PANACEUM s.r.o.
Košice, , Slovakia
Vseobecna ambulancia pre dospelych
Košice, , Slovakia
Pulmo s.r.o.,
Prešov, , Slovakia
Plucna ambulancia Hrebenar S.R.O.
Spišská Nová Ves, , Slovakia
Alergia s. r. o.
Topoľčany, , Slovakia
Panthera Biopartners
Enfield, , United Kingdom
Panthera Biopartners
Glasgow, , United Kingdom
Velocity High Wycombe
High Wycombe, , United Kingdom
4 Medical Clinical Solutions (4MCS)
London, , United Kingdom
4 Medical Clinical Solutions (4MCS)
Manchester, , United Kingdom
FutureMeds Liverpool
Metropolitan Borough of Wirral, , United Kingdom
Panthera Biopartners
Preston, , United Kingdom
Panthera Biopartners
Rochdale, , United Kingdom
Panthera Biopartners
Sheffield, , United Kingdom
Panthera Biopartners
York, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P1-FAF-16
Identifier Type: -
Identifier Source: org_study_id
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