Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.
- Conditions
- Tobacco UseCOPDSmoking
- Interventions
- Other: CigaretteOther: Smoking AbstinenceOther: THS use
- Registration Number
- NCT05569005
- Lead Sponsor
- Philip Morris Products S.A.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1895
- Subjects have read, understood, and signed the written informed consent form (ICF)
- Diagnosis of COPD GOLD Stage 1 or 2 (FEV1/FVC <0.70 & FEV1 ≥60% predicted [post-BD])
- Current symptoms of chronic bronchitis (sputum and cough) based on CAT questionnaire scores for CAT1 (cough) item ≥ 3 and CAT2 (sputum) item ≥ 3
- Body mass index (BMI) 17.6-40.0 kg/m2 and body weight > 50 kg (male) or 40 kg (female).
- Subject has a smoking history of at least 10 years.
- Subject has been smoking ≥ 10 commercially available cigarettes/day on average (no brand restriction) for at least 1 year prior to V1 (based on self-reporting).
- Subject has not used other tobacco and nicotine products apart from cigarettes on a daily basis over the past year prior to V1.
- For subjects not willing to quit smoking only: have been advised to quit smoking, informed of smoking risks and of cessation programs and is still not willing to quit during the study duration.
- Subjects willing to quit smoking only: willing to set a target quit date (TQD) within the next 28 days at V1 as assessed by self-reported questions.
Main
- Subjects with any (mild, moderate or severe) COPD exacerbation that has not resolved at least four weeks prior to V1
- Subjects with active cancer or history of any cancer
- Subjects with pneumonia or other lower respiratory tract infections that have not resolved at least four weeks prior to V1
- Subjects with other active systemic infections that have not resolved at least 4 weeks prior to V1
- Subjects with other active respiratory disorders such as, but not limited to, tuberculosis, bronchiectasis, sarcoidosis, asthma2, pulmonary hypertension, interstitial lung diseases (e.g., idiopathic pulmonary fibrosis [IPF]). No new examination is required if the subject can present at V1, at a minimum, a Chest XRay (CXR) (or Computed Tomography (CT) of the chest, if available) not older than 6 months with anterior-posterior and left lateral views
- The subject is confirmed or suspected with active SARS-CoV-2 infection (as per site and per country recommendation)
- Clinically significant ECG alterations that will not allow subject to participate in the study, per Investigator's discretion
- Any concomitant disease that in the opinion of the investigator would interfere with the study procedures
- Subjects with diagnosed alpha-1 antitrypsin deficiency (AATD)
- History of alcohol and/or drug abuse which as per judgment of the Investigator would jeopardize either the participation in an investigational study or safety of the subject
- Positive serology test (HIV 1/2, hepatitis B or C).
- Inability to cooperate with the study procedures
- Previous participation in this study, or participation in an investigational study (drug or medical device) within 4 weeks before V1 (participation in observational studies/registries allowed)
- Close affiliation with the investigational site: a close relative of the investigator, a person dependent on the investigational site (e.g., employee or student of the investigational site)
- Subject is a current or former employee of the tobacco industry or their first-degree relatives (parent, child, spouse)
- Subjects have re-initiated smoking in the six months prior to V1
- Subjects have used in the past 3 months, or are currently daily using THS
- Any oral/injectable corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation
- Female subject is pregnant or breastfeeding, (a urine pregnancy test will be performed at V1 and V2)
- For women of childbearing potential, female subject who does not agree to using an acceptable method of effective contraception during the entire study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cigarette Cigarette Subjects who are not willing to quit smoking. Smoking Abstinence Smoking Abstinence Subjects who are willing to quit smoking. THS THS use Subjects who are not willing to quit smoking.
- Primary Outcome Measures
Name Time Method Disease Progression At month 36 Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator
COPD symptoms At month 12 COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (170)
UX12; Solution Clinical Research
🇺🇸Doral, Florida, United States
UX10; Unique Clinical Trials, LLC
🇺🇸Doral, Florida, United States
UX08; TBC Research Corp.
🇺🇸Tamarac, Florida, United States
US83; Proactive Clinical Research LLC
🇺🇸Fort Lauderdale, Florida, United States
UX01; 3Sync
🇺🇸Fort Lauderdale, Florida, United States
US50; Precision Research Center
🇺🇸Tampa, Florida, United States
UX04; Clinical Trials of Tampa
🇺🇸Tampa, Florida, United States
US93; Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
US70; Harmony Medical Research Institute, Inc.
🇺🇸Hialeah, Florida, United States
US68; Global Research Associates
🇺🇸Homestead, Florida, United States
US01; Accel Research Sites-LKD CRU
🇺🇸Lakeland, Florida, United States
US25; Accel Research Sites
🇺🇸Largo, Florida, United States
US12; Leesburg Medical Research Institute, LLC
🇺🇸Leesburg, Florida, United States
US20; Accel Clinical Research
🇺🇸Maitland, Florida, United States
US43; San Marcus Research Clinic Inc
🇺🇸Miami Lakes, Florida, United States
US89; 3Sync Research - Hialeah
🇺🇸Miami Lakes, Florida, United States
US98; MedQuest Translational Sciences
🇺🇸Miami Lakes, Florida, United States
UX15; Med-Care Research Corp.
🇺🇸Miami, Florida, United States
US13; LCC Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
US48; Ocean Clinical Research, LLC
🇺🇸Miami, Florida, United States
US80; Enmanuel Advance Research Center
🇺🇸Miami, Florida, United States
UX02; Finlay Medical Research
🇺🇸Miami, Florida, United States
US84; Global Health Clinical Trials
🇺🇸Miami, Florida, United States
US86; South Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
US21; Bioclinical Research Alliance, Inc.
🇺🇸Miami, Florida, United States
US36; Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
US79; Cordova Research Institute, LLC
🇺🇸Miami, Florida, United States
UX25; D&H National Research Centers (Bird)
🇺🇸Miami, Florida, United States
US82; Florida International Medical Research
🇺🇸Miami, Florida, United States
US72; BioMed Research and Medical Center. LLC
🇺🇸Miami, Florida, United States
US55; American Research Institute
🇺🇸Miami, Florida, United States
US91; Ambert Medical Research
🇺🇸Miami, Florida, United States
US56; Medical Research of Westchester, Inc
🇺🇸Miami, Florida, United States
UX06; Wellness Research Center Inc
🇺🇸Miami, Florida, United States
US95; Premier Research Associate, Inc
🇺🇸Miami, Florida, United States
US37; Research Institute Of South Florida, Inc.
🇺🇸Miami, Florida, United States
US76; Reed Medical Research
🇺🇸Miami, Florida, United States
US90; Felicidad Medical Research
🇺🇸Miami, Florida, United States
US40; Clinical Trials of Florida, LLC
🇺🇸Miami, Florida, United States
UX07; Innovations Biotech
🇺🇸Miami, Florida, United States
UX11; United Research Group
🇺🇸Miami, Florida, United States
UX26; Harmony Clinical Research, Inc
🇺🇸North Miami Beach, Florida, United States
UX17; AES Orlando
🇺🇸Orlando, Florida, United States
US04; Omega Research Consultants
🇺🇸Orlando, Florida, United States
US10; Florida Institute for Clinical Research
🇺🇸Orlando, Florida, United States
US57; Innovation Medical Group LLC
🇺🇸Palmetto Bay, Florida, United States
US58; Bioresearch Institute LLC
🇺🇸Pembroke Pines, Florida, United States
US41; Clinovation International Corp
🇺🇸Sebring, Florida, United States
US49; Clinical Research of Brandon LLC
🇺🇸Brandon, Florida, United States
US97; Riverside Research Group
🇺🇸Cape Coral, Florida, United States
US38; Innovative Research Of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
US47; Hope Clinical Trials, Inc
🇺🇸Coral Gables, Florida, United States
UX24; Alfa Medical Research
🇺🇸Davie, Florida, United States
US94; D & H Doral Research Center, LLC
🇺🇸Doral, Florida, United States
US46; Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
US45; Clinical Site Partners, Inc. d/b/a CSP Orlando
🇺🇸Winter Park, Florida, United States
US45; Clinical Site Partners, LLC - Winter Park, Florida Premier Research Institute (FPRI)
🇺🇸Winter Park, Florida, United States
UX99; Accelerated Enrollment Solutions (AES)
🇺🇸Atlanta, Georgia, United States
US81; Oracle Clinical Research
🇺🇸College Park, Georgia, United States
US31; IACTHealth d/b/a Centricity Research
🇺🇸Rincon, Georgia, United States
US03; Inquest Clinical Research
🇺🇸Baytown, Texas, United States
UX22; ClinCept, LLC
🇺🇸Columbus, Georgia, United States
US63; Lifeline Primary Care/CCT Research
🇺🇸Lilburn, Georgia, United States
UX20; Novel Research, LLC
🇺🇸Bellaire, Texas, United States
US88; HDH Research Inc
🇺🇸Houston, Texas, United States
US42; Houston Pulmonary and Sleep Associates
🇺🇸Cypress, Texas, United States
UX34; Mt.Olympus Medical Research
🇺🇸Friendswood, Texas, United States
US73; Victorium Clinical Research
🇺🇸Houston, Texas, United States
US53; Alpha Research Institute, LLC
🇺🇸Houston, Texas, United States
US87; Biopharma Informatic Research Center
🇺🇸Houston, Texas, United States
UX14; Prolato Clinical Research Center
🇺🇸Houston, Texas, United States
UX09; Pioneer Research Solutions, Inc
🇺🇸Houston, Texas, United States
UX18; Accurate Clinical Research, Inc
🇺🇸Humble, Texas, United States
US39; Proactive Clinical Research, LLC (formerly Invesclinic, U.S. LLC)
🇺🇸McAllen, Texas, United States
US62; Metroplex Pulmonary And Sleep Medicine Center
🇺🇸McKinney, Texas, United States
UX16; Pioneer Research Solutions, Inc
🇺🇸Mesquite, Texas, United States
UX13; Synapse Clinical Research Inc.
🇺🇸Missouri City, Texas, United States
US59; Pulmonary and Sleep Institute
🇺🇸San Antonio, Texas, United States
US52; Sherman Clinical Research
🇺🇸Sherman, Texas, United States
UX21; R & H Clinical Research
🇺🇸Stafford, Texas, United States
BG30; MHAT Puls AD
🇧🇬Blagoevgrad, Bulgaria
US74; Renovatio Clinical - The Woodlands Research Center
🇺🇸The Woodlands, Texas, United States
BG28; MC Dr Staykov
🇧🇬Burgas, Bulgaria
BG03; Medical Center Asklepii OOD
🇧🇬Dupnitsa, Bulgaria
BG36; MHAT Sveti Ivan Rilski
🇧🇬Dupnitsa, Bulgaria
BG05; Medical Center Pulmo-2018 EOOD
🇧🇬Haskovo, Bulgaria
BG19; MC Zdrave 1
🇧🇬Kozloduy, Bulgaria
BG17; Diagnostic Consultative Center 1 - Lom EOOD
🇧🇬Lom, Bulgaria
BG07; Medical Center Leo Clinic
🇧🇬Lovech, Bulgaria
BG26; Medical Center Hera - Montana branch
🇧🇬Montana, Bulgaria
BG37; DCC (Diagnostic Consultative Center) 1 Pernik
🇧🇬Pernik, Bulgaria
BG32; Medconsult Pleven
🇧🇬Pleven, Bulgaria
BG40; Multiprofile Hospital for Active Treatment Trimontium
🇧🇬Plovdiv, Bulgaria
BG12; MHAT Sveti Panteleymon EOOD
🇧🇬Plovdiv, Bulgaria
BG08; Medical center Respiro
🇧🇬Razgrad, Bulgaria
BG27; Diagnostic Consultative Center 1- Sliven EOOD
🇧🇬Sliven, Bulgaria
BG29; MHAT Sliven to MMA Sofia
🇧🇬Sliven, Bulgaria
BG33; Diagnostic Consultative Centre Sliven
🇧🇬Sliven, Bulgaria
BG06; University First Multiprofile Hospital for Active treatment-Sofia EAD
🇧🇬Sofia, Bulgaria
BG31; Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
BG21; MC Preventsia 2000
🇧🇬Stara Zagora, Bulgaria
BG38; MHAT Prof. Stoyan Kirkovich
🇧🇬Stara Zagora, Bulgaria
BG01; Medical Center Zara EOOD
🇧🇬Stara Zagora, Bulgaria
BG16; Medical Centre Leo Clinic EOOD
🇧🇬Varna, Bulgaria
BG14; Medical Center Tara OOD
🇧🇬Veliko Tarnovo, Bulgaria
BG39; Specialized Hospital for Active Treatment of Pneumo-phthizilogic Diseases - Dr. Treiman - Dr. Treiman
🇧🇬Veliko Tarnovo, Bulgaria
BG22; SHATPPD Vratsa
🇧🇬Vratsa, Bulgaria
CZ05; Ordinace Hradebni s.r.o.
🇨🇿Ceske Budejovice, Czechia
CZ09; Plicni ambulance Kralupy, s.r.o.
🇨🇿Kralupy Nad Vltavou, Czechia
CZ07; MUDr. Jakub Strincl s.r.o.
🇨🇿Liberec, Czechia
CZ10; Nemocnice Mesice
🇨🇿Mesice, Czechia
CZ17; Ordinace Pro Tbc a Respiracni Nemoci s.r.o
🇨🇿Olomouc, Czechia
CZ06; PreventaMed, s.r.o.
🇨🇿Olomouc, Czechia
CZ02; Clinitrial, s.r.o.
🇨🇿Prague, Czechia
CZ03; Praglandia s.r.o.
🇨🇿Praha 5, Czechia
CZ16; Synexus Czech, s.r.o
🇨🇿Praha, Czechia
CZ08; Medison s.r.o.
🇨🇿Prestice, Czechia
CZ04; Zdravi-fit, s.r.o.
🇨🇿Protivin, Czechia
CZ12; Ordinace pro TBC a Respiracni Nemoci - Strakonice
🇨🇿Strakonice, Czechia
CZ01; Progerint s.r.o.
🇨🇿Vysoke Myto, Czechia
DE17; Klinische Forschung Berlin-Mitte
🇩🇪Berlin-Mitte, Germany
DE15; Emovis GmbH
🇩🇪Berlin, Germany
De10; Rcms
🇩🇪Berlin, Germany
DE21; Velocity Clinical Research Germany GmbH
🇩🇪Berlin, Germany
DE19; Synexus Clinical Research GmbH
🇩🇪Berlin, Germany
DE30; MECS Cottbus GmbH
🇩🇪Cottbus, Germany
DE28; Klifeck GmbH
🇩🇪Delitzsch, Germany
DE07; Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
DE26; Synexus Clinical Research GmbH
🇩🇪Frankfurt, Germany
DE06; Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
DE03; Klinische Forschung Hannover-Mitte GmbH
🇩🇪Hannover, Germany
DE01; Leipzig Research Centre-Synexus Clinical Research GmbH
🇩🇪Leipzig, Germany
DE04; Facharzt fur Innere Medizin und Pneumologie
🇩🇪Leipzig, Germany
DE12; Studienzentrum FMZ
🇩🇪Leipzig, Germany
DE27; Centrum fuer Diagnostik und Gesundheit (CDG)
🇩🇪Munich, Germany
DE25; Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig
🇩🇪Naunhof, Germany
DE14; Studienzentrum Dr.med.Schlenska
🇩🇪Peine, Germany
JP05; Tashiro Endocrinology Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
JP12; Takahashi Internal Medicine and Respiratory Clinic
🇯🇵Obihiro-shi, Hokkaido, Japan
JP11; Haruta Respiratory Clinic
🇯🇵Hiroshima-shi, Hiroshima, Japan
JP14; Sawada Clinic
🇯🇵Himeji-Shi, Hyogo-Ken, Japan
JP09; Takahashi Internal Medicine
🇯🇵Kawasaki-City, Kanagawa, Japan
JP08; Uchiyama Clinic
🇯🇵Joetsu-shi, Niigata, Japan
JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)
🇯🇵Oita-shi, Oita, Japan
JP03; Tokyo-Eki Center
🇯🇵Chuo-Ku, Tokyo, Japan
JP01; Fukuwa Clinic
🇯🇵Chuo-Ku, Tokyo, Japan
JP02; P-one Clinic
🇯🇵Hachioji-shi, Tokyo, Japan
JP06; Higashi Shinjuku Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
JP04; Sanyudo Hospital
🇯🇵Yonezawa-shi, Yamagata, Japan
RO05; Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
🇷🇴Brasov, Romania
RO04; Sc Sana Monitoring Srl
🇷🇴Bucuresti, Romania
RO06; Sc Ames Research Srl
🇷🇴Calarasi, Romania
SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne
🇸🇰Hlohovec, Slovakia
SK08; IRS - Medicínska cinnost s.r.o.
🇸🇰Kosice, Slovakia
SK01; PANACEUM s.r.o.
🇸🇰Kosice, Slovakia
SK02; MEDI M&M s.r.o.
🇸🇰Moldava Nad Bodvou, Slovakia
SK07; Hodosi-MED s.r.o.
🇸🇰Moldava nad Bodvou, Slovakia
SK05; MEDIPA, s.r.o., Vseobecna ambulancia pre dospelych
🇸🇰Piestany, Slovakia
SK12; PULMO s.r.o.
🇸🇰Presov, Slovakia
SK06; MUDr. Viliam Cibik, Phd, s.r.o.
🇸🇰Pruske, Slovakia
SK10; Plucna ambulancia Hrebenar s.r.o.
🇸🇰Spišská Nová Ves, Slovakia
SK09; Aquilamed s. r. o.
🇸🇰Stiavnik, Slovakia
SK03; Alergia, s.r.o.
🇸🇰Topolcany, Slovakia
GB07; Egin Research Ltd
🇬🇧High Wycombe, Buckinghamshire, United Kingdom
GB05; Accellacare South London
🇬🇧Orpington, Kent, United Kingdom
GB06; Velocity Clinical Research North London
🇬🇧North Finchley, London, United Kingdom
GB04; Accellacare North London
🇬🇧Northwood, Middlesex, United Kingdom
GB03; Accellacare Northamptonshire
🇬🇧Corby, Northamptonshire, United Kingdom
GB02; Accellacare Warwickshire
🇬🇧Coventry, West Midlands, United Kingdom
GB01; Accellacare Yorkshire
🇬🇧Shipley, Yorkshire, United Kingdom