Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.
NCT ID: NCT05569005
Last Updated: 2024-09-26
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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TERMINATED
NA
715 participants
INTERVENTIONAL
2022-12-16
2024-09-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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THS
Subjects who are not willing to quit smoking.
THS use
Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS
Cigarette
Subjects who are not willing to quit smoking.
Cigarette
Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
Smoking Abstinence
Subjects who are willing to quit smoking.
Smoking Abstinence
Subjects who are willing to quit smoking may be prescribed an NRT to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)
Interventions
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THS use
Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS
Cigarette
Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
Smoking Abstinence
Subjects who are willing to quit smoking may be prescribed an NRT to support them in remaining abstinent from use of any tobacco and nicotine containing products during the study. (Behavioral support will be provided to subjects to aid with abstinence.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
35 Years
65 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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Christelle Haziza, PhD
Role: STUDY_CHAIR
Philip Morris Products S.A.
Locations
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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
UX10; Unique Clinical Trials, LLC
Doral, Florida, United States
UX12; Solution Clinical Research
Doral, Florida, United States
US83; Proactive Clinical Research LLC
Fort Lauderdale, Florida, United States
UX01; 3Sync
Fort Lauderdale, 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
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
US82; Florida International Medical Research
Miami, Florida, United States
UX25; D&H National Research Centers (Bird)
Miami, Florida, United States
US72; BioMed Research and Medical Center. LLC
Miami, Florida, United States
US55; American Research Institute
Miami, Florida, United States
US56; Medical Research of Westchester, Inc
Miami, Florida, United States
US95; Premier Research Associate, Inc
Miami, Florida, United States
UX06; Wellness Research Center Inc
Miami, Florida, United States
US37; Research Institute Of South Florida, Inc.
Miami, Florida, United States
US76; Reed Medical Research
Miami, Florida, United States
US91; Ambert 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
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
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
UX08; TBC Research Corp.
Tamarac, Florida, United States
US50; Precision Research Center
Tampa, Florida, United States
UX04; Clinical Trials of Tampa
Tampa, 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
UX22; ClinCept, LLC
Columbus, Georgia, United States
US63; Lifeline Primary Care/CCT Research
Lilburn, Georgia, United States
US31; IACTHealth d/b/a Centricity Research
Rincon, Georgia, United States
US03; Inquest Clinical Research
Baytown, Texas, United States
UX20; Novel Research, LLC
Bellaire, Texas, United States
US42; Houston Pulmonary and Sleep Associates
Cypress, Texas, United States
UX34; Mt.Olympus Medical Research
Friendswood, Texas, United States
US88; HDH Research Inc
Houston, 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
US74; Renovatio Clinical - The Woodlands Research Center
The Woodlands, Texas, United States
BG30; MHAT Puls AD
Blagoevgrad, , Bulgaria
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.
České Budějovice, , Czechia
CZ09; Plicni ambulance Kralupy, s.r.o.
Kralupy nad Vltavou, , Czechia
CZ07; MUDr. Jakub Strincl s.r.o.
Liberec, , Czechia
CZ10; Nemocnice Mesice
Měšice, , 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
CZ16; Synexus Czech, s.r.o
Prague, , Czechia
CZ03; Praglandia s.r.o.
Prague, , Czechia
CZ04; Zdravi-fit, s.r.o.
Protivín, , Czechia
CZ08; Medison s.r.o.
Přeštice, , Czechia
CZ12; Ordinace pro TBC a Respiracni Nemoci - Strakonice
Strakonice, , Czechia
CZ01; Progerint s.r.o.
Vysoké Mýto, , Czechia
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
Hanover, , 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
DE17; Klinische Forschung Berlin-Mitte
Mitte, , 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, Fukuoka, Japan
JP11; Haruta Respiratory Clinic
Hiroshima, Hiroshima, Japan
JP12; Takahashi Internal Medicine and Respiratory Clinic
Obihiro-shi, Hokkaido, Japan
JP14; Sawada Clinic
Himeji-Shi, Hyōgo, Japan
JP09; Takahashi Internal Medicine
Kawasaki, Kanagawa, Japan
JP08; Uchiyama Clinic
Jōetsu, Niigata, Japan
JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)
Ōita, Oita Prefecture, 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
Bucharest, , Romania
RO06; Sc Ames Research Srl
Călăraşi, , Romania
SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne
Hlohovec, , Slovakia
SK08; IRS - Medicínska cinnost s.r.o.
Košice, , Slovakia
SK01; PANACEUM s.r.o.
Košice, , 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
Piešťany, , Slovakia
SK12; PULMO s.r.o.
Prešov, , Slovakia
SK06; MUDr. Viliam Cibik, Phd, s.r.o.
Pruské, , Slovakia
SK10; Plucna ambulancia Hrebenar s.r.o.
Spišská Nová Ves, , Slovakia
SK09; Aquilamed s. r. o.
Štiavnik, , Slovakia
SK03; Alergia, s.r.o.
Topoľčany, , 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
Countries
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Other Identifiers
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P1-COPD-04-INT
Identifier Type: -
Identifier Source: org_study_id
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