Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.

Not Applicable

Recruiting

• Conditions: Tobacco Use; COPD; Smoking
• Interventions: Other: Cigarette; Other: Smoking Abstinence; Other: 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.

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-06
• Study Start: 2022-12-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-09
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1895

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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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).

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