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

April 19, 2024 updated by: Philip Morris Products S.A.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1895

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: S. Michael Ansari
  • Phone Number: +41582421111

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Recruiting
        • BG30; MHAT Puls AD
        • Contact:
          • Elina Smilkova, M.D.
      • Burgas, Bulgaria, 8000
        • Recruiting
        • BG28; MC Dr Staykov
        • Contact:
          • Neli P Halvadzhieva, M.D.
      • Dupnitsa, Bulgaria, 2600
        • Recruiting
        • BG03; Medical Center Asklepii OOD
        • Contact:
          • Elena Kostadinova Gyuzeleva, M.D.
      • Dupnitsa, Bulgaria, 2600
        • Recruiting
        • BG36; MHAT Sveti Ivan Rilski
        • Contact:
          • Violina Milchova Vasileva, M.D.
      • Haskovo, Bulgaria, 6300
        • Recruiting
        • BG05; Medical Center Pulmo-2018 EOOD
        • Contact:
          • Veselin Kalfov, M.D.
      • Kozloduy, Bulgaria, 3320
        • Recruiting
        • BG19; MC Zdrave 1
        • Contact:
          • Rumen Tiholov, M.D.
      • Lom, Bulgaria, 3600
        • Recruiting
        • BG17; Diagnostic Consultative Center 1 - Lom EOOD
        • Contact:
          • Chavdar T Antonov, M.D.
      • Lovech, Bulgaria, 5500
        • Recruiting
        • BG07; Medical Center Leo Clinic
        • Contact:
          • Mihail Kirov, M.D.
      • Montana, Bulgaria, 3400
        • Recruiting
        • BG26; Medical Center Hera - Montana branch
        • Contact:
          • Vanko Vankov, M.D.
      • Pernik, Bulgaria, 2306
        • Recruiting
        • BG37; DCC (Diagnostic Consultative Center) 1 Pernik
        • Contact:
          • Boyko Kirilov Boyanov, M.D.
      • Pleven, Bulgaria, 5800
        • Recruiting
        • BG32; Medconsult Pleven
        • Contact:
          • Maria Todorova, M.D.
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • BG12; MHAT Sveti Panteleymon EOOD
        • Contact:
          • Atanas Parev, M.D.
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • BG40; Multiprofile Hospital for Active Treatment Trimontium
        • Contact:
          • Nikoleta Dimitrova, M.D.
      • Razgrad, Bulgaria, 7200
        • Recruiting
        • BG08; Medical center Respiro
        • Contact:
          • Ivan Kiselov, M.D.
      • Sliven, Bulgaria, 8800
        • Recruiting
        • BG27; Diagnostic Consultative Center 1- Sliven EOOD
        • Contact:
          • Dina Doseva, M.D.
      • Sliven, Bulgaria, 8800
        • Recruiting
        • BG29; MHAT Sliven to MMA Sofia
        • Contact:
          • Vanushka Petrova, M.D.
      • Sliven, Bulgaria, 8800
        • Recruiting
        • BG33; Diagnostic Consultative Centre Sliven
        • Contact:
          • Mima Dimitrova, M.D.
      • Sofia, Bulgaria, 1510
        • Recruiting
        • BG31; Medical Center Hera EOOD
        • Contact:
          • Nadya Spasova-Koteva, M.D.
      • Sofia, Bulgaria, 1142
        • Recruiting
        • BG06; University First Multiprofile Hospital for Active treatment-Sofia EAD
        • Contact:
          • Ginka Kirkova, M.D.
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • BG21; MC Preventsia 2000
        • Contact:
          • Yanitsa Zhelyazkova, M.D.
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • BG38; MHAT Prof. Stoyan Kirkovich
        • Contact:
          • Damyan G Arabadzhiev, M.D.
      • Stara Zagora, Bulgaria, 6003
        • Recruiting
        • BG01; Medical Center Zara EOOD
        • Contact:
          • Mariya Angelova-Stoyanova, M.D.
      • Varna, Bulgaria, 9020
        • Recruiting
        • BG16; Medical Centre Leo Clinic EOOD
        • Contact:
          • Iskra Velichkova, M.D.
      • Veliko Tarnovo, Bulgaria, 5000
        • Recruiting
        • BG14; Medical Center Tara OOD
        • Contact:
          • Margarita Taseva, M.D.
      • Veliko Tarnovo, Bulgaria, 5000
        • Recruiting
        • BG39; Specialized Hospital for Active Treatment of Pneumo-phthizilogic Diseases - Dr. Treiman - Dr. Treiman
        • Contact:
          • Stela Dencheva Stefanova, M.D.
      • Vratsa, Bulgaria, 3001
        • Recruiting
        • BG22; SHATPPD Vratsa
        • Contact:
          • Nezabravka Petrova Haytova, M.D.
  • Czechia
      • Ceske Budejovice, Czechia, 37001
        • Recruiting
        • CZ05; Ordinace Hradebni s.r.o.
        • Contact:
          • Ivo Petrasek, M.D.
      • Kralupy Nad Vltavou, Czechia, 27801
        • Recruiting
        • CZ09; Plicni ambulance Kralupy, s.r.o.
        • Contact:
          • Otakar Hokynar, M.D.
      • Liberec, Czechia, 460 14
        • Recruiting
        • CZ07; MUDr. Jakub Strincl s.r.o.
        • Contact:
          • Chavdar Strincl, M.D.
      • Mesice, Czechia, 25064
        • Recruiting
        • CZ10; Nemocnice Mesice
        • Contact:
          • Jaromir Musil, M.D. / PhD
      • Olomouc, Czechia, 779 00
        • Recruiting
        • CZ06; PreventaMed, s.r.o.
        • Contact:
          • Jiri J Pumprla, M.D.
      • Olomouc, Czechia, 77200
        • Recruiting
        • CZ17; Ordinace Pro Tbc a Respiracni Nemoci s.r.o
        • Contact:
          • Ondrej Sobotik, M.D.
      • Prague, Czechia, 100 00
        • Recruiting
        • CZ02; Clinitrial, s.r.o.
        • Contact:
          • Roman Gregar, M.D.
      • Praha, Czechia, 120 00
        • Recruiting
        • CZ16; Synexus Czech, s.r.o
        • Contact:
          • Marketa Hraskova, M.D.
      • Praha 5, Czechia, 150 00
        • Recruiting
        • CZ03; Praglandia s.r.o.
        • Contact:
          • Vera Klokocnikova, M.D.
      • Prestice, Czechia, 33401
        • Recruiting
        • CZ08; Medison s.r.o.
        • Contact:
          • Petr Sonka, M.D.
      • Protivin, Czechia, 398 11
        • Recruiting
        • CZ04; Zdravi-fit, s.r.o.
        • Contact:
          • Jan Kolar, M.D.
      • Strakonice, Czechia, 386 01
        • Recruiting
        • CZ12; Ordinace pro TBC a Respiracni Nemoci - Strakonice
        • Contact:
          • Jaroslav Mares, M.D.
      • Vysoke Myto, Czechia, 56601
        • Recruiting
        • CZ01; Progerint s.r.o.
        • Contact:
          • Pavol Salamon, M.D.
  • Germany
      • Berlin, Germany, 10629
        • Recruiting
        • DE15; Emovis GmbH
        • Contact:
          • Kerstin Sturm, M.D.
      • Berlin, Germany, 10717
        • Recruiting
        • De10; Rcms
        • Contact:
          • Anneliese E Linnhoff, M.D.
      • Berlin, Germany, 10787
        • Recruiting
        • DE21; Velocity Clinical Research Germany GmbH
        • Contact:
          • Isabelle Schenkenberger, M.D.
      • Berlin, Germany, 12627
        • Recruiting
        • DE19; Synexus Clinical Research GmbH
        • Contact:
          • Konrad Janik, M.D.
      • Berlin-Mitte, Germany, 10117
        • Recruiting
        • DE17; Klinische Forschung Berlin-Mitte
        • Contact:
          • Hartmut Tischner, M.D.
      • Cottbus, Germany, 3050
        • Recruiting
        • DE30; MECS Cottbus GmbH
        • Contact:
          • Frank Kaessner, M.D.
      • Delitzsch, Germany, 4509
        • Recruiting
        • DE28; Klifeck GmbH
        • Contact:
          • Gerald Eckhardt, M.D.
      • Dresden, Germany, 1069
        • Recruiting
        • DE07; Klinische Forschung Dresden GmbH
        • Contact:
          • Andrea Guenzel, M.D.
      • Frankfurt, Germany, 60313
        • Recruiting
        • DE26; Synexus Clinical Research GmbH
        • Contact:
          • Florieke Berfelo, M.D.
      • Hamburg, Germany, 20253
        • Recruiting
        • DE06; Klinische Forschung Hamburg GmbH
        • Contact:
          • Christian Deckert, M.D.
      • Hannover, Germany, 30159
        • Recruiting
        • DE03; Klinische Forschung Hannover-Mitte GmbH
        • Contact:
          • Khalida Sidiqy, M.D.
      • Leipzig, Germany, 4103
        • Recruiting
        • DE01; Leipzig Research Centre-Synexus Clinical Research GmbH
        • Contact:
          • Katrin Arelin, M.D.
      • Leipzig, Germany, 4157
        • Recruiting
        • DE04; Facharzt fur Innere Medizin und Pneumologie
        • Contact:
          • Falk Brunner, M.D.
      • Leipzig, Germany, 4179
        • Recruiting
        • DE12; Studienzentrum FMZ
        • Contact:
          • Frank Radowsky, M.D.
      • Munich, Germany, 80809
        • Recruiting
        • DE27; Centrum fuer Diagnostik und Gesundheit (CDG)
        • Contact:
          • Manfred Hartard, M.D.
      • Naunhof, Germany, 4683
        • Recruiting
        • DE25; Gemeinschaftspraxis Dres. Holger Kittner und Kerstin Hartig
        • Contact:
          • Holger Kittner, M.D.
      • Peine, Germany, 31224
        • Recruiting
        • DE14; Studienzentrum Dr.med.Schlenska
        • Contact:
          • Christian Schlenska, M.D.
  • Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0153
        • Recruiting
        • JP05; Tashiro Endocrinology Clinic
        • Contact:
          • Naotaka Tashiro, M.D.
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 730-0853
        • Recruiting
        • JP11; Haruta Respiratory Clinic
        • Contact:
          • Yoshinori Haruta, M.D.
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan, 080-0013
        • Recruiting
        • JP12; Takahashi Internal Medicine and Respiratory Clinic
        • Contact:
          • Toshiki Takahashi, M.D.
    • Hyogo-Ken
      • Himeji-Shi, Hyogo-Ken, Japan, 670-0942
        • Recruiting
        • JP14; Sawada Clinic
        • Contact:
          • Shigeki Sawada, M.D.
    • Kanagawa
      • Kawasaki-City, Kanagawa, Japan, 211-0041
        • Recruiting
        • JP09; Takahashi Internal Medicine
        • Contact:
          • Masamitsu Takahashi, M.D.
    • Niigata
      • Joetsu-shi, Niigata, Japan, 949-3443
        • Recruiting
        • JP08; Uchiyama Clinic
        • Contact:
          • Kazuaki Uchiyama, M.D.
    • Oita
      • Oita-shi, Oita, Japan, 870-0921
        • Recruiting
        • JP10; Yamagata Clinic (Goto-J Respiratory and Allergy Clinic)
        • Contact:
          • Eiji Yamagata, M.D.
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 103-0027
        • Recruiting
        • JP03; Tokyo-Eki Center
        • Contact:
          • Arihiro Kiyosue, M.D.
      • Chuo-Ku, Tokyo, Japan, 104-0031
        • Recruiting
        • JP01; Fukuwa Clinic
        • Contact:
          • Yasushi Fukushima, M.D.
      • Hachioji-shi, Tokyo, Japan, 192-0071
        • Recruiting
        • JP02; P-one Clinic
        • Contact:
          • Kenichi Furihata, M.D.
      • Shinjuku-ku, Tokyo, Japan, 169-0072
        • Recruiting
        • JP06; Higashi Shinjuku Clinic
        • Contact:
          • Hiroaki Kondo, M.D.
    • Yamagata
      • Yonezawa-shi, Yamagata, Japan, 992-0045
        • Recruiting
        • JP04; Sanyudo Hospital
        • Contact:
          • Hideki Ikeda, M.D.
  • Romania
      • Brasov, Romania, 500283
        • Recruiting
        • RO05; Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
        • Contact:
          • Laurentia D Andrei, M.D.
      • Bucuresti, Romania, 11025
        • Recruiting
        • RO04; Sc Sana Monitoring Srl
        • Contact:
          • Adrian Sarbu, M.D.
      • Calarasi, Romania, 910103
        • Recruiting
        • RO06; Sc Ames Research Srl
        • Contact:
          • Georgiana M Enache, M.D.
  • Slovakia
      • Hlohovec, Slovakia, 92001
        • Recruiting
        • SK04; DIVERSITAS s.r.o. - Hlohovec vseobecne
        • Contact:
          • Lukas Vanco, M.D.
      • Kosice, Slovakia, 4001
        • Recruiting
        • SK08; IRS - Medicínska cinnost s.r.o.
        • Contact:
          • Elena Adamkovicova, M.D.
      • Kosice, Slovakia, 4011
        • Recruiting
        • SK01; PANACEUM s.r.o.
        • Contact:
          • Lenka Barbierik, M.D.
      • Moldava Nad Bodvou, Slovakia, 045 01
        • Recruiting
        • SK02; MEDI M&M s.r.o.
        • Contact:
          • Michal Banik, M.D.
      • Moldava nad Bodvou, Slovakia, 045 01
        • Recruiting
        • SK07; Hodosi-MED s.r.o.
        • Contact:
          • Vlastimil Ratvaj, M.D.
      • Piestany, Slovakia, 92101
        • Recruiting
        • SK05; MEDIPA, s.r.o., Vseobecna ambulancia pre dospelych
        • Contact:
          • Stanislav Paluga, M.D.
      • Presov, Slovakia, 8001
        • Recruiting
        • SK12; PULMO s.r.o.
        • Contact:
          • Luboslava Frajtova, M.D.
      • Pruske, Slovakia, 018 52
        • Recruiting
        • SK06; MUDr. Viliam Cibik, Phd, s.r.o.
        • Contact:
          • Viliam Cibik, M.D.
      • Spišská Nová Ves, Slovakia, 052 01
        • Recruiting
        • SK10; Plucna ambulancia Hrebenar s.r.o.
        • Contact:
          • Slavomir Hrebenar, M.D.
      • Stiavnik, Slovakia, 1355
        • Recruiting
        • SK09; Aquilamed s. r. o.
        • Contact:
          • Alexander Orlinsky, M.D.
      • Topolcany, Slovakia, 955 01
        • Recruiting
        • SK03; Alergia, s.r.o.
        • Contact:
          • Igor Paluga, M.D.
  • United Kingdom
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2QW
    • Kent
      • Orpington, Kent, United Kingdom, BR5 3QG
    • London
      • North Finchley, London, United Kingdom, N12 8BU
        • Recruiting
        • GB06; Velocity Clinical Research North London
        • Contact:
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN18 9EZ
        • Recruiting
        • GB03; Accellacare Northamptonshire
        • Contact:
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV3 4FJ
    • Yorkshire
      • Shipley, Yorkshire, United Kingdom, BD18 3SA
  • United States
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • US49; Clinical Research of Brandon LLC
        • Contact:
          • German Alvarez, M.D.
      • Cape Coral, Florida, United States, 33909
        • Recruiting
        • US97; Riverside Research Group
        • Contact:
          • Manuel Diaz, M.D.
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • US38; Innovative Research Of West Florida, Inc.
        • Contact:
          • Miguel E Trevino, M.D.
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • US47; Hope Clinical Trials, Inc
        • Contact:
          • Jose Pinero, M.D.
      • Davie, Florida, United States, 33024
        • Recruiting
        • UX24; Alfa Medical Research
        • Contact:
          • Ramon M Garcia-Septien, M.D.
      • Doral, Florida, United States, 33122
        • Recruiting
        • US94; D & H Doral Research Center, LLC
        • Contact:
          • Ana Cecilia de Aguiar Cury, M.D.
      • Doral, Florida, United States, 33172
        • Recruiting
        • UX10; Unique Clinical Trials, LLC
        • Contact:
          • Amado Viera, M.D.
      • Doral, Florida, United States, 33178
        • Recruiting
        • UX12; Solution Clinical Research
        • Contact:
          • Aurelio Varona, M.D.
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • US83; Proactive Clinical Research LLC
        • Contact:
          • David Mishkin, M.D,
      • Fort Lauderdale, Florida, United States, 33309
        • Recruiting
        • UX01; 3Sync
        • Contact:
          • Rafael Orlando Nunez-Avila, M.D.
      • Greenacres City, Florida, United States, 33467
        • Recruiting
        • US93; Finlay Medical Research
        • Contact:
          • Jorge Javier Calle Medina, M.D.
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • US70; Harmony Medical Research Institute, Inc.
        • Contact:
          • Juan Miguel Fernandez, M.D.
      • Homestead, Florida, United States, 33030
        • Recruiting
        • US68; Global Research Associates
        • Contact:
          • Jose A Cobiella, M.D.
      • Lakeland, Florida, United States, 33803
        • Recruiting
        • US01; Accel Research Sites-LKD CRU
        • Contact:
          • James L Andersen, M.D.
      • Largo, Florida, United States, 33777
        • Recruiting
        • US25; Accel Research Sites
        • Contact:
          • Shital-Hiten Jitendra Upadhyay, M.D.
      • Leesburg, Florida, United States, 34748
        • Recruiting
        • US12; Leesburg Medical Research Institute, LLC
        • Contact:
          • Jose L Diaz, M.D.
      • Maitland, Florida, United States, 32751
        • Recruiting
        • US20; Accel Clinical Research
        • Contact:
          • Eva-Maria Heurich, M.D.
      • Miami, Florida, United States, 33126
        • Recruiting
        • US13; LCC Medical Research Institute, LLC
        • Contact:
          • Yamirka Duardo-Guerra, M.D.
      • Miami, Florida, United States, 33126
        • Recruiting
        • US48; Ocean Clinical Research, LLC
        • Contact:
          • Richard Perez, M.D,
      • Miami, Florida, United States, 33126
        • Recruiting
        • US80; Enmanuel Advance Research Center
        • Contact:
          • Arles Perdomo, M.D.
      • Miami, Florida, United States, 33135
        • Recruiting
        • US84; Global Health Clinical Trials
        • Contact:
          • Humberto Fernandez-Miro, M.D.
      • Miami, Florida, United States, 33135
        • Recruiting
        • US86; South Florida Research Center, Inc.
        • Contact:
          • Omar Benitez, M.D.
      • Miami, Florida, United States, 33155
        • Recruiting
        • US21; Bioclinical Research Alliance, Inc.
        • Contact:
          • Rogelio Iglesias, M.D.
      • Miami, Florida, United States, 33155
        • Recruiting
        • US36; Allied Biomedical Research Institute
        • Contact:
          • Michael M Pfeffer, M.D.
      • Miami, Florida, United States, 33155
        • Recruiting
        • US79; Cordova Research Institute, LLC
        • Contact:
          • Guillermo Somodevilla, M.D.
      • Miami, Florida, United States, 33155
        • Recruiting
        • US82; Florida International Medical Research
        • Contact:
          • Erick Juarez, M.D.
      • Miami, Florida, United States, 33165
        • Recruiting
        • US56; Medical Research of Westchester, Inc
        • Contact:
          • Esperanza Arce-Nunez, M.D.
      • Miami, Florida, United States, 33173
        • Recruiting
        • US37; Research Institute Of South Florida, Inc.
        • Contact:
          • Roberto Sotolongo, M.D.
      • Miami, Florida, United States, 33176
        • Recruiting
        • US76; Reed Medical Research
        • Contact:
          • Ariel Ramirez Navarro, M.D.
      • Miami, Florida, United States, 33186
        • Recruiting
        • US40; Clinical Trials of Florida, LLC
        • Contact:
          • Mark Rosenthal, D.O.
      • Miami, Florida, United States, 33125
        • Recruiting
        • UX15; Med-Care Research Corp.
        • Contact:
          • Adalberto Aguilera, M.D.
      • Miami, Florida, United States, 33126
        • Recruiting
        • UX02; Finlay Medical Research
        • Contact:
          • Lilia R Rodriguez-Ables, M.D.
      • Miami, Florida, United States, 33155
        • Recruiting
        • UX25; D&H National Research Centers (Bird)
        • Contact:
          • Jorge Perez Amaya, M.D.
      • Miami, Florida, United States, 33156
        • Recruiting
        • US72; BioMed Research and Medical Center. LLC
        • Contact:
          • Liliam Hernandez, M.D.
      • Miami, Florida, United States, 33157
        • Recruiting
        • US55; American Research Institute
        • Contact:
          • Daimis Vazquez Rosabal, M.D.
      • Miami, Florida, United States, 33165
        • Recruiting
        • US95; Premier Research Associate, Inc
        • Contact:
          • Gilda M De la Calle, M.D.
      • Miami, Florida, United States, 33165
        • Recruiting
        • UX06; Wellness Research Center Inc
        • Contact:
          • Ramses Vega, M.D.
      • Miami, Florida, United States, 33176
        • Recruiting
        • US91; Ambert Medical Research
        • Contact:
          • Fernando Bolufer, M.D.
      • Miami, Florida, United States, 33184
        • Recruiting
        • US90; Felicidad Medical Research
        • Contact:
          • Francisco N Bautista, M.D.
      • Miami, Florida, United States, 33186
        • Recruiting
        • UX07; Innovations Biotech
        • Contact:
          • Rafael Ubeda, M.D.
      • Miami, Florida, United States, 33186
        • Recruiting
        • UX11; United Research Group
        • Contact:
          • Ernesto Fernandez, M.D.
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • US43; San Marcus Research Clinic Inc
        • Contact:
          • Idalia A Acosta, M.D.
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • US89; 3Sync Research - Hialeah
        • Contact:
          • Miguel A Aponte, M.D.
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • US98; MedQuest Translational Sciences
        • Contact:
          • Yeissen Godinez, M.D.
      • North Miami Beach, Florida, United States, 33162
        • Recruiting
        • UX26; Harmony Clinical Research, Inc
        • Contact:
          • Howard Reinfeld, M.D.
      • Orlando, Florida, United States, 32808
        • Recruiting
        • US04; Omega Research Consultants
        • Contact:
          • Kwabena Ayesu, M.D.
      • Orlando, Florida, United States, 32825
        • Recruiting
        • US10; Florida Institute for Clinical Research
        • Contact:
          • Humberto N Cruz, D.O.
      • Orlando, Florida, United States, 32806
        • Recruiting
        • UX17; AES Orlando
        • Contact:
          • Beatriz Colon, M.D.
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • US57; Innovation Medical Group LLC
        • Contact:
          • Karen Figueredo Reyes, M.D.
      • Pembroke Pines, Florida, United States, 33026
        • Recruiting
        • US58; Bioresearch Institute LLC
        • Contact:
          • Julio C Reyes-Gavilan, M.D.
      • Sebring, Florida, United States, 33870
        • Recruiting
        • US41; Clinovation International Corp
        • Contact:
          • Dennis R Bassetti, M.D.
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • UX08; TBC Research Corp.
        • Contact:
          • Barry Streit, M.D.
      • Tampa, Florida, United States, 33614
        • Recruiting
        • US50; Precision Research Center
        • Contact:
          • German Alvarez, M.D.
      • Tampa, Florida, United States, 33614
        • Recruiting
        • UX04; Clinical Trials of Tampa
        • Contact:
          • Victor A Silva, M.D.
      • West Palm Beach, Florida, United States, 33409
        • Recruiting
        • US46; Palm Beach Research Center
        • Contact:
          • Mira Baron, M.D.
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • US45; Clinical Site Partners, Inc. d/b/a CSP Orlando
        • Contact:
          • Jorge Enrique Monroy Avella, M.D.
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • US45; Clinical Site Partners, LLC - Winter Park, Florida Premier Research Institute (FPRI)
        • Contact:
          • Jose L Diaz, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • UX99; Accelerated Enrollment Solutions (AES)
        • Contact:
          • Muhammad S Munir, M.D.
      • College Park, Georgia, United States, 30349
        • Recruiting
        • US81; Oracle Clinical Research
        • Contact:
          • Carlos M Martinez, M.D.
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • UX22; ClinCept, LLC
        • Contact:
          • Joshua Samraj, M.D.
      • Lilburn, Georgia, United States, 30047
        • Recruiting
        • US63; Lifeline Primary Care/CCT Research
        • Contact:
          • Aziz Pirani, M.D.
      • Rincon, Georgia, United States, 31326
        • Recruiting
        • US31; IACTHealth d/b/a Centricity Research
        • Contact:
          • Maria Mascolo, M.D.
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • US03; Inquest Clinical Research
        • Contact:
          • Haider Afzal, M.D.
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • UX20; Novel Research, LLC
        • Contact:
          • Everald O Manning, M.D.
      • Cypress, Texas, United States, 77429
        • Recruiting
        • US42; Houston Pulmonary and Sleep Associates
        • Contact:
          • Srinivas Vodnala, M.D.
      • Friendswood, Texas, United States, 77546
        • Recruiting
        • UX34; Mt.Olympus Medical Research
        • Contact:
          • Efrain Soto, M.D.
      • Houston, Texas, United States, 77024
        • Recruiting
        • US73; Victorium Clinical Research
        • Contact:
          • Ankur A Doshi, M.D.
      • Houston, Texas, United States, 77036
        • Recruiting
        • US53; Alpha Research Institute, LLC
        • Contact:
          • Esteban Berberian, M.D.
      • Houston, Texas, United States, 77022
        • Recruiting
        • US88; HDH Research Inc
        • Contact:
          • Francisco Ortiz, M.D.
      • Houston, Texas, United States, 77043
        • Recruiting
        • US87; Biopharma Informatic Research Center
        • Contact:
          • Agadadash Kuliev, M.D.
      • Houston, Texas, United States, 77054
        • Recruiting
        • UX14; Prolato Clinical Research Center
        • Contact:
          • Sreedhar Mandayam, M.D.
      • Houston, Texas, United States, 77099
        • Recruiting
        • UX09; Pioneer Research Solutions, Inc
        • Contact:
          • Francisco Velazquez, M.D.
      • Humble, Texas, United States, 77338
        • Recruiting
        • UX18; Accurate Clinical Research, Inc
        • Contact:
          • Nilay Mehta, M.D.
      • McAllen, Texas, United States, 78503
        • Recruiting
        • US39; Proactive Clinical Research, LLC (formerly Invesclinic, U.S. LLC)
        • Contact:
          • Maria D Coimbra, M.D.
      • McKinney, Texas, United States, 75069
        • Recruiting
        • US62; Metroplex Pulmonary And Sleep Medicine Center
        • Contact:
          • Shahrukh A Kureishy, M.D.
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • UX16; Pioneer Research Solutions, Inc
        • Contact:
          • Sohail Parekh, M.D.
      • Missouri City, Texas, United States, 77459
        • Recruiting
        • UX13; Synapse Clinical Research Inc.
        • Contact:
          • Naseer N Khan, M.D.
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • US59; Pulmonary and Sleep Institute
        • Contact:
          • David Marks, M.D.
      • Sherman, Texas, United States, 75092
        • Recruiting
        • US52; Sherman Clinical Research
        • Contact:
          • Muqdad Zuriqat, M.D.
      • Stafford, Texas, United States, 77477
        • Recruiting
        • UX21; R & H Clinical Research
        • Contact:
          • Sayyed Farhan Ali Jaffri, M.D.
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • US74; Renovatio Clinical - The Woodlands Research Center
        • Contact:
          • Ather Siddiqi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: THS
Subjects who are not willing to quit smoking.
Other: THS use
Subjects who are not willing to quit smoking during the study duration will switch from cigarettes to using THS
Other Names:
  • Tobacco Heating System 3.0
Active Comparator: Cigarette
Subjects who are not willing to quit smoking.
Other: Cigarette
Subjects who are not willing to quit smoking during the study duration will continue smoking their own preferred brand of commercially available cigarettes.
Active Comparator: Smoking Abstinence
Subjects who are willing to quit smoking.
Other: 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.)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philip Morris Products S.A.

Investigators

  • Study Chair: Christelle Haziza, PhD, Philip Morris Products S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1-COPD-04-INT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Clinical Trials on THS use

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe