A Randomized, Single (Operator)-Blinded, Controlled Clinical Study for Assessing Major Symptoms and Function in Patients With Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis Who Switch From Combustible Cigarettes (CIG) to Tobacco Heating System (THS)

Status: Recruiting
Location: See all (105) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Adult, both sexes, aged ≥ 40 years.

• Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.

• Patient with body mass index (BMI) 17.6-40.0 kg/m2 and body weight \> 50 kg (male) or \> 40 kg (female). Checked at V1 and V2.

• Patient has a CIG smoking history ≥ 10 years.

• Patient has been smoking ≥ 10 commercially available and/or roll-your-own CIG/day on average (no brand restriction) for at least the last year (based on self-reporting). Smoking status will be verified by Urine cotinine test (UCOT) ≥200 ng/mL. Intermittent CIG smoking abstinence, with or without Smoking Cessation Treatment during these attempts, not exceeding 10 days total within the past year will be allowed. Checked at V1 and V2.

• Patient has been advised to quit smoking, informed of smoking risks and of cessation programs as per SoC at V2, and is not willing to quit CIG use for the study duration. Checked at V1 and V2.

• Patient agrees to be randomized into one of the two study arms. Checked at V2.

• Patient with confirmed COPD via spirometry performed at V1 (FEV1/FVC \<70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 \< 80% predicted, -BD) with presence of chronic bronchitis (cough and mucus most of the days for \> three months a year for the two consecutive years prior to the screening visit). Checked at V2.

• Patient has cough frequency of ≥ 10 cough/hour during daytime from objective count sensor applied at V1, used to verify eligibility at V2. (Daytime is defined as occurring between 07:00:00 and 22:59:59, based on the local time zone of the site where the patient is assessed.)

Locations
United States
Florida
Clinical Research of West Florida, Inc.
NOT_YET_RECRUITING
Clearwater
Florida International Medical Research
RECRUITING
Coral Gables
Alfa Medical Research
RECRUITING
Davie
Omega Research Debary, LLC
NOT_YET_RECRUITING
Debary
D&H Doral Research Center
RECRUITING
Doral
Felicidad Med Research
RECRUITING
Hialeah
The Medici Medical Research, LLC
NOT_YET_RECRUITING
Hollywood
D&H Pompano Research Center
RECRUITING
Margate
Biomed Research & Medical Center.Llc
RECRUITING
Miami
D&H National Research Center- Miami
RECRUITING
Miami
EMDA Clincal Research
RECRUITING
Miami
Global Health Clinical Trials Corp.
RECRUITING
Miami
Med-Care Research Corp
RECRUITING
Miami
Melgar-Caro Medcenter and Community Research
RECRUITING
Miami
Newgen Health Group
RECRUITING
Miami
Professional Research Center Inc
RECRUITING
Miami
Reserka LLC
RECRUITING
Miami
Sones Medical Research
RECRUITING
Miami
Suncoast Research Group, LLC dba Flourish Research
NOT_YET_RECRUITING
Miami
MedQuest Translational Sciences LLC
RECRUITING
Miami Lakes
Pharma Medical Innovations
NOT_YET_RECRUITING
Miami Lakes
San Marcus Research
RECRUITING
Miami Lakes
Advanced Research Institute, Inc
RECRUITING
New Port Richey
Harmony Clinical Research
NOT_YET_RECRUITING
North Miami Beach
Central Florida Pulmonary Group, P.A.
NOT_YET_RECRUITING
Orlando
Comprehensive Medical & Research Center
NOT_YET_RECRUITING
Plantation
CDC Research Institute
NOT_YET_RECRUITING
Port Saint Lucie
Treasure Coast Medical Research Group
RECRUITING
Port Saint Lucie
Advanced Research Institute, Inc
NOT_YET_RECRUITING
St. Petersburg
D&H Tamarac Research Center
RECRUITING
Tamarac
Metropolitan Clinical Research Center
NOT_YET_RECRUITING
Tamarac
Optimum Clinical Trial Group
RECRUITING
Tampa
Georgia
Pivotal Research Solutions
RECRUITING
Stonecrest
Texas
Premier Pulmonary Critical Care and Sleep Medicine
NOT_YET_RECRUITING
Denison
El Paso Pulmonary Association
NOT_YET_RECRUITING
El Paso
HDH Research Inc
NOT_YET_RECRUITING
Houston
Houston Pulmonary Medicine Associates
RECRUITING
Houston
Pioneer Research Solutions Inc
RECRUITING
Houston
Prolato Research LLC.
NOT_YET_RECRUITING
Houston
Accurate Clinical Research, Inc.
RECRUITING
Humble
Metroplex Pulmonary & Sleep Center
NOT_YET_RECRUITING
Mckinney
Element Research Group
RECRUITING
San Antonio
Medrasa Clinical Research
NOT_YET_RECRUITING
Sherman
Pulmonics Plus
RECRUITING
Waxahachie
Other Locations
Bulgaria
MHAT Rahila Angelova
RECRUITING
Pernik
Medical Center Hera EOOD
NOT_YET_RECRUITING
Sofia
Medical Center Pulmovision Ltd
NOT_YET_RECRUITING
Sofia
MHAT Lyulin EAD
NOT_YET_RECRUITING
Sofia
SHATPD Dr. Treyman
NOT_YET_RECRUITING
Veliko Tarnovo
SHATPPD Vratsa
RECRUITING
Vratsa
Germany
Klinische Forschung Berlin Mitte /Pratia Germany
NOT_YET_RECRUITING
Berlin
Research Center for Medical Studies
RECRUITING
Berlin
Klifeck GmbH
RECRUITING
Delitzsch
Klinische Forschung Hannover-Mitte GmbH /Pratia Germany
NOT_YET_RECRUITING
Hanover
Klinische Forschung Karlsruhe GmbH / Pratio Germany
NOT_YET_RECRUITING
Karlsruhe
Facharzt für Innere Medizin und Pneumologie
NOT_YET_RECRUITING
Leipzig
POIS Sachsen GmbH
NOT_YET_RECRUITING
Leipzig
Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH
NOT_YET_RECRUITING
Neu-isenburg
FutureMeds Frankfurt
RECRUITING
Offenbach
Praxis Reinfeld Mitte
NOT_YET_RECRUITING
Reinfeld
Siteworks - Prüfzentrum Schleswig | RespiRatio
RECRUITING
Schleswig
BAG Peter Fried / Dr. med. Roman Rubin
NOT_YET_RECRUITING
Wiesbaden
Velocity Clinical Research Wiesbaden
NOT_YET_RECRUITING
Wiesbaden
Lungenpraxis Witten
RECRUITING
Witten
Japan
Soejima Clinic
RECRUITING
Fukuoka
JCHO Nihonmatsu Hospital
RECRUITING
Fukushima
Maebashi North Hospital
RECRUITING
Gunma
Akashi Medical Center
RECRUITING
Hyōgo
Fukuwa Clinic
RECRUITING
Tokyo
Kouwa Clinic
RECRUITING
Tokyo
Sanyuudo Hospital
RECRUITING
Yamagata
Yokohama Minoru Clinic
RECRUITING
Yokohama
Clinical Research Hospital Tokyo
RECRUITING
Yotsuya
Poland
Centrum Medycyny Oddechowej Mroz Spolka jawna
RECRUITING
Bialystok
BioResearch Group Sp. z.o.o
NOT_YET_RECRUITING
Kajetany
FutureMeds Krakowskie Centrum Medyczne
RECRUITING
Krakow
AmiCare Centrum Medyczne
NOT_YET_RECRUITING
Lodz
FutureMeds Łódź
RECRUITING
Lodz
RCMed Oddział Sochaczew
NOT_YET_RECRUITING
Sochaczew
FutureMeds Targówek
NOT_YET_RECRUITING
Warsaw
FutureMeds Warszawa Centrum
NOT_YET_RECRUITING
Warsaw
Dobrostan
NOT_YET_RECRUITING
Wroclaw
FutureMeds Wrocław
NOT_YET_RECRUITING
Wroclaw
Romania
Ames Research Center
NOT_YET_RECRUITING
Bragadiru
Sc. Centrul Medical Sana Srl
NOT_YET_RECRUITING
Brasov
Sana Medical Center
RECRUITING
Bucharest
Ames Research Center
NOT_YET_RECRUITING
Călăraşi
Clintrial Medical Centre SRL
RECRUITING
Dobrosloveni
Spital de Pneumologie dr Lavinia Davidescu Oradea
RECRUITING
Oradea
AI Clinical Research
NOT_YET_RECRUITING
Sibiu
Slovakia
PANACEUM s.r.o.
NOT_YET_RECRUITING
Košice
Vseobecna ambulancia pre dospelych
NOT_YET_RECRUITING
Košice
Pulmo s.r.o.,
NOT_YET_RECRUITING
Prešov
Plucna ambulancia Hrebenar S.R.O.
RECRUITING
Spišská Nová Ves
Alergia s. r. o.
RECRUITING
Topoľčany
United Kingdom
Panthera Biopartners
NOT_YET_RECRUITING
Enfield
Panthera Biopartners
NOT_YET_RECRUITING
Glasgow
Velocity High Wycombe
NOT_YET_RECRUITING
High Wycombe
4 Medical Clinical Solutions (4MCS)
NOT_YET_RECRUITING
London
4 Medical Clinical Solutions (4MCS)
NOT_YET_RECRUITING
Manchester
FutureMeds Liverpool
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Panthera Biopartners
NOT_YET_RECRUITING
Preston
Panthera Biopartners
NOT_YET_RECRUITING
Rochdale
Panthera Biopartners
NOT_YET_RECRUITING
Sheffield
Panthera Biopartners
NOT_YET_RECRUITING
York
Contact Information
Primary
Xavier Jaumont, MD
Xavier.Jaumont@pmi.com
+41582421111
Time Frame
Start Date: 2025-04-02
Estimated Completion Date: 2026-11
Participants
Target number of participants: 290
Treatments
Active_comparator: Cigarette
Active_comparator: THS
Sponsors
Leads: Philip Morris Products S.A.

This content was sourced from clinicaltrials.gov