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

COPD Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569005
• Other study ID #: P1-COPD-04-INT
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Philip Morris Products S.A.
• Contact: Christelle Haziza, PhD
• Phone: +41582421111
• Email: Christelle.Haziza[@]pmi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1895
• Est. completion date: June 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• COPD
• Disease Progression
• Smoking
• Tobacco Use

Intervention

Other:
• 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.)

Locations

Country	Name	City	State
Bulgaria	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	BG12; MHAT Sveti Panteleymon EOOD	Plovdiv
Bulgaria	BG40; Multiprofile Hospital for Active Treatment Trimontium	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	BG01; Medical Center Zara EOOD	Stara Zagora
Bulgaria	BG21; MC Preventsia 2000	Stara Zagora
Bulgaria	BG38; MHAT Prof. Stoyan Kirkovich	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
Czechia	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	CZ06; PreventaMed, s.r.o.	Olomouc
Czechia	CZ17; Ordinace Pro Tbc a Respiracni Nemoci s.r.o	Olomouc
Czechia	CZ02; Clinitrial, s.r.o.	Prague
Czechia	CZ16; Synexus Czech, s.r.o	Praha
Czechia	CZ03; Praglandia s.r.o.	Praha 5
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
Germany	De10; Rcms	Berlin
Germany	DE15; Emovis GmbH	Berlin
Germany	DE19; Synexus Clinical Research GmbH	Berlin
Germany	DE21; Velocity Clinical Research Germany GmbH	Berlin
Germany	DE17; Klinische Forschung Berlin-Mitte	Berlin-Mitte
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
Japan	JP01; Fukuwa Clinic	Chuo-Ku	Tokyo
Japan	JP03; Tokyo-Eki Center	Chuo-Ku	Tokyo
Japan	JP05; Tashiro Endocrinology Clinic	Fukuoka-shi	Fukuoka
Japan	JP02; P-one Clinic	Hachioji-shi	Tokyo
Japan	JP14; Sawada Clinic	Himeji-Shi	Hyogo-Ken
Japan	JP11; Haruta Respiratory Clinic	Hiroshima-shi	Hiroshima
Japan	JP08; Uchiyama Clinic	Joetsu-shi	Niigata
Japan	JP09; Takahashi Internal Medicine	Kawasaki-City	Kanagawa
Japan	JP12; Takahashi Internal Medicine and Respiratory Clinic	Obihiro-shi	Hokkaido
Japan	JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)	Oita-shi	Oita
Japan	JP06; Higashi Shinjuku Clinic	Shinjuku-ku	Tokyo
Japan	JP04; Sanyudo Hospital	Yonezawa-shi	Yamagata
Romania	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
Slovakia	SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne	Hlohovec
Slovakia	SK01; PANACEUM s.r.o.	Kosice
Slovakia	SK08; IRS - Medicínska cinnost 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
United Kingdom	GB03; Accellacare Northamptonshire	Corby	Northamptonshire
United Kingdom	GB02; Accellacare Warwickshire	Coventry	West Midlands
United Kingdom	GB07; Egin Research Ltd	High Wycombe	Buckinghamshire
United Kingdom	GB06; Velocity Clinical Research North London	North Finchley	London
United Kingdom	GB04; Accellacare North London	Northwood	Middlesex
United Kingdom	GB05; Accellacare South London	Orpington	Kent
United Kingdom	GB01; Accellacare Yorkshire	Shipley	Yorkshire
United States	UX99; Accelerated Enrollment Solutions (AES)	Atlanta	Georgia
United States	US03; Inquest Clinical Research	Baytown	Texas
United States	UX20; Novel Research, LLC	Bellaire	Texas
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	US81; Oracle Clinical Research	College Park	Georgia
United States	UX22; ClinCept, LLC	Columbus	Georgia
United States	US47; Hope Clinical Trials, Inc	Coral Gables	Florida
United States	US42; Houston Pulmonary and Sleep Associates	Cypress	Texas
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	UX34; Mt.Olympus Medical Research	Friendswood	Texas
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	US53; Alpha Research Institute, LLC	Houston	Texas
United States	US73; Victorium Clinical Research	Houston	Texas
United States	US87; Biopharma Informatic Research Center	Houston	Texas
United States	US88; HDH Research Inc	Houston	Texas
United States	UX09; Pioneer Research Solutions, Inc	Houston	Texas
United States	UX14; Prolato Clinical Research Center	Houston	Texas
United States	UX18; Accurate Clinical Research, Inc	Humble	Texas
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	US63; Lifeline Primary Care/CCT Research	Lilburn	Georgia
United States	US20; Accel Clinical Research	Maitland	Florida
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	US13; LCC Medical Research Institute, LLC	Miami	Florida
United States	US21; Bioclinical Research Alliance, Inc.	Miami	Florida
United States	US36; Allied Biomedical Research Institute	Miami	Florida
United States	US37; Research Institute Of South Florida, Inc.	Miami	Florida
United States	US40; Clinical Trials of Florida, LLC	Miami	Florida
United States	US48; Ocean Clinical Research, LLC	Miami	Florida
United States	US55; American Research Institute	Miami	Florida
United States	US56; Medical Research of Westchester, Inc	Miami	Florida
United States	US72; BioMed Research and Medical Center. LLC	Miami	Florida
United States	US76; Reed Medical Research	Miami	Florida
United States	US79; Cordova Research Institute, LLC	Miami	Florida
United States	US80; Enmanuel Advance Research Center	Miami	Florida
United States	US82; Florida International 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	US90; Felicidad Medical Research	Miami	Florida
United States	US91; Ambert Medical Research	Miami	Florida
United States	US95; Premier Research Associate, Inc	Miami	Florida
United States	UX02; Finlay Medical Research	Miami	Florida
United States	UX06; Wellness Research Center Inc	Miami	Florida
United States	UX07; Innovations Biotech	Miami	Florida
United States	UX11; United Research Group	Miami	Florida
United States	UX15; Med-Care Research Corp.	Miami	Florida
United States	UX25; D&H National Research Centers (Bird)	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	UX13; Synapse Clinical Research Inc.	Missouri City	Texas
United States	UX26; Harmony Clinical Research, Inc	North Miami Beach	Florida
United States	US04; Omega Research Consultants	Orlando	Florida
United States	US10; Florida Institute for Clinical Research	Orlando	Florida
United States	UX17; AES Orlando	Orlando	Florida
United States	US57; Innovation Medical Group LLC	Palmetto Bay	Florida
United States	US58; Bioresearch Institute LLC	Pembroke Pines	Florida
United States	US31; IACTHealth d/b/a Centricity Research	Rincon	Georgia
United States	US59; Pulmonary and Sleep Institute	San Antonio	Texas
United States	US41; Clinovation International Corp	Sebring	Florida
United States	US52; Sherman Clinical Research	Sherman	Texas
United States	UX21; R & H Clinical Research	Stafford	Texas
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	US74; Renovatio Clinical - The Woodlands Research Center	The Woodlands	Texas
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

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Germany,  Japan,  Romania,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression	Disease progression will be assessed by measuring Forced Expiratory Volume in 1 second (FEV1), post-bronchodilator	At month 36
Primary	COPD symptoms	COPD symptoms will be assessed from the total score of the COPD Assessment Test (CAT).	At month 12