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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette | Active Comparator |
| |
| THS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette | Other | COPD patients will continue to smoke their cigarettes ad libitum, with no brand restrictions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in 24-hour cough frequency | To demonstrate a change in 24-hour cough frequency in COPD patients with chronic bronchitis switching from cigarette (CIG) to THS compared to those who continue to smoke CIG. | Measured from start of product use to end of week 24 (end of the exposure period). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lung function (from Baseline in FEV1 post-bronchodilator) | To describe changes from Baseline in FEV1 post-bronchodilator in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. | Measured from start of product use to end of week 24 (end of the exposure period). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier Jaumont, MD | Contact | +41582421111 | Xavier.Jaumont@pmi.com |
| Name | Affiliation | Role |
|---|---|---|
| Xavier Jaumont, MD | Philip Morris Products S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research of West Florida, Inc. | Active, not recruiting | Clearwater | Florida | 33765 | United States | |
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| THS | Other | COPD patients will switch from cigarette smoking to ad libitum THS use, with no flavor variant restrictions. |
|
| Changes in the 24-hour cough frequency over time |
To describe changes in the 24-hour cough frequency over time in in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. |
| Measured from start of product use to 12 weeks, at the end of weeks 1, 4, and 12. |
| Percentage of patients with a change in 24-hour cough frequency over time | To describe the percentage of patients with a change in 24-hour cough frequency over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24 |
| Changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough | To describe changes in the Cough Quality of Life Questionnaire (CQLQ) on chronic cough in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. It consists of 28 items to which the patient responds on a 4-point Likert scale, ranging from 1=strongly disagree, to 4=strongly agree. The total score is the sum of all individual items. Lower scores indicate a better outcome. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24. |
| Changes in cough severity over time | To describe changes in cough severity over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24. |
| Changes in bronchial hyperresponsiveness (BHR) mannitol test over time | To describe changes in bronchial hyperresponsiveness (BHR) mannitol test over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG, at sites with full testing capabilities for BHR testing. | Measured from start of product use to end of week 24 (end of the exposure period). |
| Impact of COPD (cough, sputum, dyspnea, chest tightness) on health status | To assess the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status in COPD by the COPD Assessment Test (CAT) over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. The CAT questionnaire consists of eight items, each answered on a semantic six-point differential scale from 0 to 5. The CAT score is calculated as the sum of the responses. Scores range from 0 to 40 with higher scores representing worse health outcomes. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24. |
| Changes in shortness of breath assessed over time | To describe changes in shortness of breath assessed over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. | Measured from start of product use to end of week 24 (end of the exposure period). |
| Changes in functional capacity over time | To describe changes in functional capacity over time in COPD patients with chronic bronchitis switching from CIG to THS compared to those who continue to smoke CIG. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 12 and 24. |
| Changes in exposure to carbon monoxide over time | Change from Baseline in carbon monoxide (CO) exposure levels measured from venous blood carboxyhemoglobin (COHb) at the end of weeks 1, 4, 12, and 24. | Measured from start of product use to end of week 24 (end of the exposure period). |
| Changes in self-reported tobacco and nicotine containing product consumption | Changes from Baseline in self-reported tobacco and nicotine containing product consumption and change in self-reported CIG and overall tobacco consumption evaluated with the ABOUT Tobacco exposure Tool (ABOUT-TeT). This instrument is a questionnaire to record self-reported consumption of tobacco and nicotine containing products. Patients will be asked to self-report the number of CIG, THS Induction Sticks, and other tobacco and nicotine containing products used on average per day over the last week. Patients will complete the questionnaire every seven days, from week 1 to week 24. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24. |
| Changes in nicotine exposure levels | Change from Baseline in nicotine exposure levels in spot urine adjusted to creatinine (Nicotine equivalents [NEQ]). | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24. |
| Changes in acrylonitrile exposure levels | Change from Baseline in acrylonitrile exposure levels in 2-Cyanoethyl Mercapturic Acid N-Acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA) measured in urine and expressed as concentration adjusted to creatinine. | Measured from start of product use to 24 weeks (end of the exposure period), at the end of weeks 1, 4, 12, and 24. |
| Florida International Medical Research |
| Active, not recruiting |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Alfa Medical Research | Active, not recruiting | Davie | Florida | 33024 | United States |
| Omega Research Debary, LLC | Active, not recruiting | DeBary | Florida | 32713 | United States |
| D&H Doral Research Center | Active, not recruiting | Doral | Florida | 33122 | United States |
| Felicidad Med Research | Active, not recruiting | Hialeah | Florida | 33012 | United States |
| New Life Medical Research Center, Inc | Not yet recruiting | Hialeah | Florida | 33012 | United States |
|
| The Medici Medical Research, LLC | Active, not recruiting | Hollywood | Florida | 33021 | United States |
| D&H Pompano Research Center | Active, not recruiting | Margate | Florida | 33063 | United States |
| Med-Care Research Corp | Active, not recruiting | Miami | Florida | 33125 | United States |
| EMDA Clincal Research | Active, not recruiting | Miami | Florida | 33126 | United States |
| Sones Medical Research | Active, not recruiting | Miami | Florida | 33133 | United States |
| Suncoast Research Group, LLC dba Flourish Research | Active, not recruiting | Miami | Florida | 33135 | United States |
| Melgar-Caro Medcenter and Community Research | Active, not recruiting | Miami | Florida | 33145 | United States |
| D&H National Research Center- Miami | Active, not recruiting | Miami | Florida | 33155.0 | United States |
| Biomed Research & Medical Center.Llc | Active, not recruiting | Miami | Florida | 33156 | United States |
| Global Health Clinical Trials Corp. | Active, not recruiting | Miami | Florida | 33165 | United States |
| Professional Research Center Inc | Active, not recruiting | Miami | Florida | 33172 | United States |
| Newgen Health Group | Active, not recruiting | Miami | Florida | 33176 | United States |
| Reserka LLC | Active, not recruiting | Miami | Florida | 33176 | United States |
| Pharma Medical Innovations | Active, not recruiting | Miami Lakes | Florida | 33014 | United States |
| San Marcus Research | Active, not recruiting | Miami Lakes | Florida | 33015 | United States |
| MedQuest Translational Sciences LLC | Active, not recruiting | Miami Lakes | Florida | 33016.0 | United States |
| Advanced Research Institute, Inc | Active, not recruiting | New Port Richey | Florida | 34653 | United States |
| Harmony Clinical Research | Active, not recruiting | North Miami Beach | Florida | 33162 | United States |
| Central Florida Pulmonary Group, P.A. | Active, not recruiting | Orlando | Florida | 32803 | United States |
| Comprehensive Medical & Research Center | Active, not recruiting | Plantation | Florida | 33317 | United States |
| CDC Research Institute | Active, not recruiting | Port Saint Lucie | Florida | 34952 | United States |
| Treasure Coast Medical Research Group | Active, not recruiting | Port Saint Lucie | Florida | 34986 | United States |
| Advanced Research Institute, Inc | Active, not recruiting | St. Petersburg | Florida | 33710 | United States |
| D&H Tamarac Research Center | Active, not recruiting | Tamarac | Florida | 33321 | United States |
| Metropolitan Clinical Research Center | Active, not recruiting | Tamarac | Florida | 33321 | United States |
| Optimum Clinical Trial Group | Active, not recruiting | Tampa | Florida | 33612 | United States |
| Guardian Angel | Active, not recruiting | Tampa | Florida | 33614 | United States |
| Pivotal Research Solutions | Active, not recruiting | Stonecrest | Georgia | 30038 | United States |
| Premier Pulmonary Critical Care and Sleep Medicine | Active, not recruiting | Denison | Texas | 75020 | United States |
| El Paso Pulmonary Association | Active, not recruiting | El Paso | Texas | 79902 | United States |
| HDH Research Inc | Active, not recruiting | Houston | Texas | 77022 | United States |
| Prolato Research LLC. | Active, not recruiting | Houston | Texas | 77054 | United States |
| Houston Pulmonary Medicine Associates | Active, not recruiting | Houston | Texas | 77089 | United States |
| Pioneer Research Solutions Inc | Active, not recruiting | Houston | Texas | 77099 | United States |
| Accurate Clinical Research, Inc. | Active, not recruiting | Humble | Texas | 77338 | United States |
| Metroplex Pulmonary & Sleep Center | Active, not recruiting | McKinney | Texas | 75069 | United States |
| LinQ Research, LLC | Active, not recruiting | Pearland | Texas | 77584 | United States |
| Element Research Group | Active, not recruiting | San Antonio | Texas | 78258 | United States |
| Medrasa Clinical Research | Active, not recruiting | Sherman | Texas | 75092 | United States |
| MHAT Rahila Angelova | Active, not recruiting | Pernik | 2300 | Bulgaria |
| MHAT Lyulin EAD | Active, not recruiting | Sofia | 1336 | Bulgaria |
| Medical Center Hera EOOD | Not yet recruiting | Sofia | 1510 | Bulgaria |
|
| Medical Center Pulmovision Ltd | Active, not recruiting | Sofia | 1756 | Bulgaria |
| SHATPD Dr. Treyman | Not yet recruiting | Veliko Tarnovo | 5003 | Bulgaria |
|
| SHATPPD Vratsa | Active, not recruiting | Vratsa | 3000 | Bulgaria |
| MUDr. Otakar Hokynar - plicni ambulance | Active, not recruiting | Kralupy nad Vltavou | 278 01 | Czechia |
| Ordinace pro tbc a respirační nemoci s.r.o. | Active, not recruiting | Olomouc | 779 00 | Czechia |
| CCR Ostrava s.r.o. | Active, not recruiting | Ostrava | 702 00 | Czechia |
| Medicon a.s. | Active, not recruiting | Prague | 140 00 | Czechia |
| Prvni plicni ambulance s.r.o. | Active, not recruiting | Prague | 190 00 | Czechia |
| Pneumologie Varnsdorf s.r.o. | Active, not recruiting | Varnsdorf | 407 47 | Czechia |
| Klinische Forschung Berlin Mitte /Pratia Germany | Active, not recruiting | Berlin | 10117 | Germany |
| Research Center for Medical Studies | Active, not recruiting | Berlin | 10717 | Germany |
| Klifeck GmbH | Active, not recruiting | Delitzsch | 4509 | Germany |
| Klinische Forschung Hannover-Mitte GmbH /Pratia Germany | Active, not recruiting | Hanover | 30159 | Germany |
| Klinische Forschung Karlsruhe GmbH / Pratio Germany | Active, not recruiting | Karlsruhe | 76137 | Germany |
| Facharzt für Innere Medizin und Pneumologie | Active, not recruiting | Leipzig | 04157 | Germany |
| POIS Sachsen GmbH | Active, not recruiting | Leipzig | 4509 | Germany |
| Ballenberger Freytag Wenisch - Institut für klinische Forschung GmbH | Active, not recruiting | Neu-Isenburg | 63263 | Germany |
| FutureMeds Frankfurt | Active, not recruiting | Offenbach | 63065 | Germany |
| Praxis Reinfeld Mitte | Active, not recruiting | Reinfeld | 23858 | Germany |
| Siteworks - Prüfzentrum Schleswig | RespiRatio | Active, not recruiting | Schleswig | 24837 | Germany |
| BAG Peter Fried / Dr. med. Roman Rubin | Active, not recruiting | Wiesbaden | 65183 | Germany |
| Velocity Clinical Research Wiesbaden | Active, not recruiting | Wiesbaden | 65189 | Germany |
| Lungenpraxis Witten | Active, not recruiting | Witten | 58452 | Germany |
| Soejima Clinic | Active, not recruiting | Fukuoka | 812-0016 | Japan |
| Maebashi North Hospital | Active, not recruiting | Gunma | 371-0054 | Japan |
| Akashi Medical Center | Active, not recruiting | Hyōgo | 674-0063 | Japan |
| Fukuwa Clinic | Active, not recruiting | Tokyo | 104-0031 | Japan |
| Kouwa Clinic | Active, not recruiting | Tokyo | 170-0003 | Japan |
| Tokyo Medical University Hachioji Medical Center | Active, not recruiting | Tokyo | 193-0998 | Japan |
| Sanyuudo Hospital | Active, not recruiting | Yamagata | 992-0045 | Japan |
| Yokohama Minoru Clinic | Active, not recruiting | Yokohama | 232-0064 | Japan |
| Clinical Research Hospital Tokyo | Active, not recruiting | Yotsuya | 160-0004 | Japan |
| Centrum Medycyny Oddechowej Mroz Spolka jawna | Active, not recruiting | Bialystok | 15-044 | Poland |
| BioResearch Group Sp. z.o.o | Active, not recruiting | Kajetany | 05-830 | Poland |
| FutureMeds Krakowskie Centrum Medyczne | Active, not recruiting | Krakow | 31-501 | Poland |
| FutureMeds Łódź | Active, not recruiting | Lodz | 91-363 | Poland |
| RCMed Oddział Sochaczew | Active, not recruiting | Sochaczew | 96-500 | Poland |
| FutureMeds Warszawa Centrum | Active, not recruiting | Warsaw | 00-215 | Poland |
| FutureMeds Targówek | Active, not recruiting | Warsaw | 03-291 | Poland |
| Dobrostan | Active, not recruiting | Wroclaw | 53-301 | Poland |
| FutureMeds Wrocław | Active, not recruiting | Wroclaw | 53-673 | Poland |
| Ames Research Center | Active, not recruiting | Bragadiru | 077025 | Romania |
| Sc. Centrul Medical Sana Srl | Active, not recruiting | Brasov | 500440 | Romania |
| Sana Medical Center | Active, not recruiting | Bucharest | 11025 | Romania |
| Ames Research Center | Active, not recruiting | Calarasi | 910103 | Romania |
| Clintrial Medical Centre SRL | Recruiting | Dobrosloveni | 237143 | Romania |
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| Spital de Pneumologie dr Lavinia Davidescu Oradea | Active, not recruiting | Oradea | 410163 | Romania |
| AI Clinical Research | Not yet recruiting | Sibiu | 550082 | Romania |
|
| PANACEUM s.r.o. | Not yet recruiting | Košice | 040 01 | Slovakia |
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| Vseobecna ambulancia pre dospelych | Not yet recruiting | Košice | 040 01 | Slovakia |
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| Pulmo s.r.o., | Active, not recruiting | Prešov | 080 01 | Slovakia |
| Plucna ambulancia Hrebenar S.R.O. | Active, not recruiting | Spišská Nová Ves | 5201 | Slovakia |
| Alergia s. r. o. | Active, not recruiting | Topoľčany | 955 01 | Slovakia |
| Panthera Biopartners | Active, not recruiting | Enfield | EN3 4GS | United Kingdom |
| Panthera Biopartners | Active, not recruiting | Glasgow | G51 4TF | United Kingdom |
| Velocity High Wycombe | Active, not recruiting | High Wycombe | HP11 2QW | United Kingdom |
| 4 Medical Clinical Solutions (4MCS) | Active, not recruiting | London | IG1 4HP | United Kingdom |
| 4 Medical Clinical Solutions (4MCS) | Active, not recruiting | Manchester | M27 8FF | United Kingdom |
| FutureMeds Liverpool | Active, not recruiting | Metropolitan Borough of Wirral | CH62 6EE | United Kingdom |
| Panthera Biopartners | Active, not recruiting | Preston | PR2 9QB | United Kingdom |
| Panthera Biopartners | Active, not recruiting | Rochdale | OL11 4AU | United Kingdom |
| Panthera Biopartners | Active, not recruiting | Sheffield | S2 5FX | United Kingdom |
| Panthera Biopartners | Active, not recruiting | York | YO24 4LJ | United Kingdom |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012907 | Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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