Clinical trial NCT05569005: Effect of Switching From Cigarette Smoking to THS on Disease Progression in Mild to Moderate COPD Subjects With Chronic Bronchitis Symptoms.
Official title: A 3-year, 3-group, Preference, Multi-center Study to Demonstrate the Slowing of Disease Progression When Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) Subjects With a History of Chronic Bronchitis Symptoms.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Smoking
Tobacco Use
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 715
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multiregional (Europe, U.S. and Asia) multi-center, open-label study with 3-group, parallel preference design (Cigarette, THS use and Smoking Abstinence).
Primary purpose: OTHER

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.

Eligibility criteria: Main 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 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.

Primary outcomes:
measure: Disease Progression
timeFrame: At month 36
measure: COPD symptoms
timeFrame: At month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Brandon
country: United States
facility: US49; Clinical Research of Brandon LLC
state: Florida
city: Cape Coral
country: United States
facility: US97; Riverside Research Group
state: Florida
city: Clearwater
country: United States
facility: US38; Innovative Research Of West Florida, Inc.
state: Florida
city: Coral Gables
country: United States
facility: US47; Hope Clinical Trials, Inc
state: Florida
city: Davie
country: United States
facility: UX24; Alfa Medical Research
state: Florida
city: Doral
country: United States
facility: US94; D & H Doral Research Center, LLC
state: Florida
city: Doral
country: United States
facility: UX10; Unique Clinical Trials, LLC
state: Florida
city: Doral
country: United States
facility: UX12; Solution Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: US83; Proactive Clinical Research LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: UX01; 3Sync
state: Florida
city: Greenacres City
country: United States
facility: US93; Finlay Medical Research
state: Florida
city: Hialeah
country: United States
facility: US70; Harmony Medical Research Institute, Inc.
state: Florida
city: Homestead
country: United States
facility: US68; Global Research Associates
state: Florida
city: Lakeland
country: United States
facility: US01; Accel Research Sites-LKD CRU
state: Florida
city: Largo
country: United States
facility: US25; Accel Research Sites
state: Florida
city: Leesburg
country: United States
facility: US12; Leesburg Medical Research Institute, LLC
state: Florida
city: Maitland
country: United States
facility: US20; Accel Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: US43; San Marcus Research Clinic Inc
state: Florida
city: Miami Lakes
country: United States
facility: US89; 3Sync Research - Hialeah
state: Florida
city: Miami Lakes
country: United States
facility: US98; MedQuest Translational Sciences
state: Florida
city: Miami
country: United States
facility: UX15; Med-Care Research Corp.
state: Florida
city: Miami
country: United States
facility: US13; LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: US48; Ocean Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: US80; Enmanuel Advance Research Center
state: Florida
city: Miami
country: United States
facility: UX02; Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: US84; Global Health Clinical Trials
state: Florida
city: Miami
country: United States
facility: US86; South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: US21; Bioclinical Research Alliance, Inc.
state: Florida
city: Miami
country: United States
facility: US36; Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: US79; Cordova Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: US82; Florida International Medical Research
state: Florida
city: Miami
country: United States
facility: UX25; D&H National Research Centers (Bird)
state: Florida
city: Miami
country: United States
facility: US72; BioMed Research and Medical Center. LLC
state: Florida
city: Miami
country: United States
facility: US55; American Research Institute
state: Florida
city: Miami
country: United States
facility: US56; Medical Research of Westchester, Inc
state: Florida
city: Miami
country: United States
facility: US95; Premier Research Associate, Inc
state: Florida
city: Miami
country: United States
facility: UX06; Wellness Research Center Inc
state: Florida
city: Miami
country: United States
facility: US37; Research Institute Of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: US76; Reed Medical Research
state: Florida
city: Miami
country: United States
facility: US91; Ambert Medical Research
state: Florida
city: Miami
country: United States
facility: US90; Felicidad Medical Research
state: Florida
city: Miami
country: United States
facility: US40; Clinical Trials of Florida, LLC
state: Florida
city: Miami
country: United States
facility: UX07; Innovations Biotech
state: Florida
city: Miami
country: United States
facility: UX11; United Research Group
state: Florida
city: North Miami Beach
country: United States
facility: UX26; Harmony Clinical Research, Inc
state: Florida
city: Orlando
country: United States
facility: UX17; AES Orlando
state: Florida
city: Orlando
country: United States
facility: US04; Omega Research Consultants
state: Florida
city: Orlando
country: United States
facility: US10; Florida Institute for Clinical Research
state: Florida
city: Palmetto Bay
country: United States
facility: US57; Innovation Medical Group LLC
state: Florida
city: Pembroke Pines
country: United States
facility: US58; Bioresearch Institute LLC
state: Florida
city: Sebring
country: United States
facility: US41; Clinovation International Corp
state: Florida
city: Tamarac
country: United States
facility: UX08; TBC Research Corp.
state: Florida
city: Tampa
country: United States
facility: US50; Precision Research Center
state: Florida
city: Tampa
country: United States
facility: UX04; Clinical Trials of Tampa
state: Florida
city: West Palm Beach
country: United States
facility: US46; Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: US45; Clinical Site Partners, Inc. d/b/a CSP Orlando
state: Florida
city: Winter Park
country: United States
facility: US45; Clinical Site Partners, LLC - Winter Park, Florida Premier Research Institute (FPRI)
state: Florida
city: Atlanta
country: United States
facility: UX99; Accelerated Enrollment Solutions (AES)
state: Georgia
city: College Park
country: United States
facility: US81; Oracle Clinical Research
state: Georgia
city: Columbus
country: United States
facility: UX22; ClinCept, LLC
state: Georgia
city: Lilburn
country: United States
facility: US63; Lifeline Primary Care/CCT Research
state: Georgia
city: Rincon
country: United States
facility: US31; IACTHealth d/b/a Centricity Research
state: Georgia
city: Baytown
country: United States
facility: US03; Inquest Clinical Research
state: Texas
city: Bellaire
country: United States
facility: UX20; Novel Research, LLC
state: Texas
city: Cypress
country: United States
facility: US42; Houston Pulmonary and Sleep Associates
state: Texas
city: Friendswood
country: United States
facility: UX34; Mt.Olympus Medical Research
state: Texas
city: Houston
country: United States
facility: US88; HDH Research Inc
state: Texas
city: Houston
country: United States
facility: US73; Victorium Clinical Research
state: Texas
city: Houston
country: United States
facility: US53; Alpha Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: US87; Biopharma Informatic Research Center
state: Texas
city: Houston
country: United States
facility: UX14; Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: UX09; Pioneer Research Solutions, Inc
state: Texas
city: Humble
country: United States
facility: UX18; Accurate Clinical Research, Inc
state: Texas
city: McAllen
country: United States
facility: US39; Proactive Clinical Research, LLC (formerly Invesclinic, U.S. LLC)
state: Texas
city: McKinney
country: United States
facility: US62; Metroplex Pulmonary And Sleep Medicine Center
state: Texas
city: Mesquite
country: United States
facility: UX16; Pioneer Research Solutions, Inc
state: Texas
city: Missouri City
country: United States
facility: UX13; Synapse Clinical Research Inc.
state: Texas
city: San Antonio
country: United States
facility: US59; Pulmonary and Sleep Institute
state: Texas
city: Sherman
country: United States
facility: US52; Sherman Clinical Research
state: Texas
city: Stafford
country: United States
facility: UX21; R & H Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: US74; Renovatio Clinical - The Woodlands Research Center
state: Texas
city: Blagoevgrad
country: Bulgaria
facility: BG30; MHAT Puls AD
city: Burgas
country: Bulgaria
facility: BG28; MC Dr Staykov
city: Dupnitsa
country: Bulgaria
facility: BG03; Medical Center Asklepii OOD
city: Dupnitsa
country: Bulgaria
facility: BG36; MHAT Sveti Ivan Rilski
city: Haskovo
country: Bulgaria
facility: BG05; Medical Center Pulmo-2018 EOOD
city: Kozloduy
country: Bulgaria
facility: BG19; MC Zdrave 1
city: Lom
country: Bulgaria
facility: BG17; Diagnostic Consultative Center 1 - Lom EOOD
city: Lovech
country: Bulgaria
facility: BG07; Medical Center Leo Clinic
city: Montana
country: Bulgaria
facility: BG26; Medical Center Hera - Montana branch
city: Pernik
country: Bulgaria
facility: BG37; DCC (Diagnostic Consultative Center) 1 Pernik
city: Pleven
country: Bulgaria
facility: BG32; Medconsult Pleven
city: Plovdiv
country: Bulgaria
facility: BG40; Multiprofile Hospital for Active Treatment Trimontium
city: Plovdiv
country: Bulgaria
facility: BG12; MHAT Sveti Panteleymon EOOD
city: Razgrad
country: Bulgaria
facility: BG08; Medical center Respiro
city: Sliven
country: Bulgaria
facility: BG27; Diagnostic Consultative Center 1- Sliven EOOD
city: Sliven
country: Bulgaria
facility: BG29; MHAT Sliven to MMA Sofia
city: Sliven
country: Bulgaria
facility: BG33; Diagnostic Consultative Centre Sliven
city: Sofia
country: Bulgaria
facility: BG06; University First Multiprofile Hospital for Active treatment-Sofia EAD
city: Sofia
country: Bulgaria
facility: BG31; Medical Center Hera EOOD
city: Stara Zagora
country: Bulgaria
facility: BG21; MC Preventsia 2000
city: Stara Zagora
country: Bulgaria
facility: BG38; MHAT Prof. Stoyan Kirkovich
city: Stara Zagora
country: Bulgaria
facility: BG01; Medical Center Zara EOOD
city: Varna
country: Bulgaria
facility: BG16; Medical Centre Leo Clinic EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: BG14; Medical Center Tara OOD
city: Veliko Tarnovo
country: Bulgaria
facility: BG39; Specialized Hospital for Active Treatment of Pneumo-phthizilogic Diseases - Dr. Treiman - Dr. Treiman
city: Vratsa
country: Bulgaria
facility: BG22; SHATPPD Vratsa
city: Ceske Budejovice
country: Czechia
facility: CZ05; Ordinace Hradebni s.r.o.
city: Kralupy Nad Vltavou
country: Czechia
facility: CZ09; Plicni ambulance Kralupy, s.r.o.
city: Liberec
country: Czechia
facility: CZ07; MUDr. Jakub Strincl s.r.o.
city: Mesice
country: Czechia
facility: CZ10; Nemocnice Mesice
city: Olomouc
country: Czechia
facility: CZ17; Ordinace Pro Tbc a Respiracni Nemoci s.r.o
city: Olomouc
country: Czechia
facility: CZ06; PreventaMed, s.r.o.
city: Prague
country: Czechia
facility: CZ02; Clinitrial, s.r.o.
city: Praha 5
country: Czechia
facility: CZ03; Praglandia s.r.o.
city: Praha
country: Czechia
facility: CZ16; Synexus Czech, s.r.o
city: Prestice
country: Czechia
facility: CZ08; Medison s.r.o.
city: Protivin
country: Czechia
facility: CZ04; Zdravi-fit, s.r.o.
city: Strakonice
country: Czechia
facility: CZ12; Ordinace pro TBC a Respiracni Nemoci - Strakonice
city: Vysoke Myto
country: Czechia
facility: CZ01; Progerint s.r.o.
city: Berlin-Mitte
country: Germany
facility: DE17; Klinische Forschung Berlin-Mitte
city: Berlin
country: Germany
facility: DE15; Emovis GmbH
city: Berlin
country: Germany
facility: De10; Rcms
city: Berlin
country: Germany
facility: DE21; Velocity Clinical Research Germany GmbH
city: Berlin
country: Germany
facility: DE19; Synexus Clinical Research GmbH
city: Cottbus
country: Germany
facility: DE30; MECS Cottbus GmbH
city: Delitzsch
country: Germany
facility: DE28; Klifeck GmbH
city: Dresden
country: Germany
facility: DE07; Klinische Forschung Dresden GmbH
city: Frankfurt
country: Germany
facility: DE26; Synexus Clinical Research GmbH
city: Hamburg
country: Germany
facility: DE06; Klinische Forschung Hamburg GmbH
city: Hannover
country: Germany
facility: DE03; Klinische Forschung Hannover-Mitte GmbH
city: Leipzig
country: Germany
facility: DE01; Leipzig Research Centre-Synexus Clinical Research GmbH
city: Leipzig
country: Germany
facility: DE04; Facharzt fur Innere Medizin und Pneumologie
city: Leipzig
country: Germany
facility: DE12; Studienzentrum FMZ
city: Munich
country: Germany
facility: DE27; Centrum fuer Diagnostik und Gesundheit (CDG)
city: Naunhof
country: Germany
facility: DE25; Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig
city: Peine
country: Germany
facility: DE14; Studienzentrum Dr.med.Schlenska
city: Fukuoka-shi
country: Japan
facility: JP05; Tashiro Endocrinology Clinic
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: JP11; Haruta Respiratory Clinic
state: Hiroshima
city: Obihiro-shi
country: Japan
facility: JP12; Takahashi Internal Medicine and Respiratory Clinic
state: Hokkaido
city: Himeji-Shi
country: Japan
facility: JP14; Sawada Clinic
state: Hyogo-Ken
city: Kawasaki-City
country: Japan
facility: JP09; Takahashi Internal Medicine
state: Kanagawa
city: Joetsu-shi
country: Japan
facility: JP08; Uchiyama Clinic
state: Niigata
city: Oita-shi
country: Japan
facility: JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)
state: Oita
city: Chuo-Ku
country: Japan
facility: JP03; Tokyo-Eki Center
state: Tokyo
city: Chuo-Ku
country: Japan
facility: JP01; Fukuwa Clinic
state: Tokyo
city: Hachioji-shi
country: Japan
facility: JP02; P-one Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: JP06; Higashi Shinjuku Clinic
state: Tokyo
city: Yonezawa-shi
country: Japan
facility: JP04; Sanyudo Hospital
state: Yamagata
city: Brasov
country: Romania
facility: RO05; Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
city: Bucuresti
country: Romania
facility: RO04; Sc Sana Monitoring Srl
city: Calarasi
country: Romania
facility: RO06; Sc Ames Research Srl
city: Hlohovec
country: Slovakia
facility: SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne
city: Kosice
country: Slovakia
facility: SK08; IRS - Medicínska cinnost s.r.o.
city: Kosice
country: Slovakia
facility: SK01; PANACEUM s.r.o.
city: Moldava Nad Bodvou
country: Slovakia
facility: SK02; MEDI M&M s.r.o.
city: Moldava nad Bodvou
country: Slovakia
facility: SK07; Hodosi-MED s.r.o.
city: Piestany
country: Slovakia
facility: SK05; MEDIPA, s.r.o., Vseobecna ambulancia pre dospelych
city: Presov
country: Slovakia
facility: SK12; PULMO s.r.o.
city: Pruske
country: Slovakia
facility: SK06; MUDr. Viliam Cibik, Phd, s.r.o.
city: Spišská Nová Ves
country: Slovakia
facility: SK10; Plucna ambulancia Hrebenar s.r.o.
city: Stiavnik
country: Slovakia
facility: SK09; Aquilamed s. r. o.
city: Topolcany
country: Slovakia
facility: SK03; Alergia, s.r.o.
city: High Wycombe
country: United Kingdom
facility: GB07; Egin Research Ltd
state: Buckinghamshire
city: Orpington
country: United Kingdom
facility: GB05; Accellacare South London
state: Kent
city: North Finchley
country: United Kingdom
facility: GB06; Velocity Clinical Research North London
state: London
city: Northwood
country: United Kingdom
facility: GB04; Accellacare North London
state: Middlesex
city: Corby
country: United Kingdom
facility: GB03; Accellacare Northamptonshire
state: Northamptonshire
city: Coventry
country: United Kingdom
facility: GB02; Accellacare Warwickshire
state: West Midlands
city: Shipley
country: United Kingdom
facility: GB01; Accellacare Yorkshire
state: Yorkshire
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
References: