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Centrul Medical Sana Srl","Brasov","500440",{"type":45,"coordinates":795},[796,797],25.60613,45.64861,{"lat":797,"lon":796},{"facility":800,"status":38,"city":801,"state":11,"zip":802,"country":783,"countryCode":784,"cosmosGeoPoint":803,"geoPoint":807,"contacts":11},"Sana Medical Center","Bucharest","11025",{"type":45,"coordinates":804},[805,806],26.10626,44.43225,{"lat":806,"lon":805},{"facility":780,"status":38,"city":809,"state":11,"zip":810,"country":783,"countryCode":784,"cosmosGeoPoint":811,"geoPoint":815,"contacts":11},"Calarasi","910103",{"type":45,"coordinates":812},[813,814],27.31356,44.2051,{"lat":814,"lon":813},{"facility":817,"status":818,"city":819,"state":11,"zip":820,"country":783,"countryCode":784,"cosmosGeoPoint":821,"geoPoint":825,"contacts":826},"Clintrial Medical Centre SRL","RECRUITING","Dobrosloveni","237143",{"type":45,"coordinates":822},[823,824],24.36667,44.18333,{"lat":824,"lon":823},[827],{"name":828,"role":32,"phone":829,"phoneExt":11,"email":830},"Denisa Popa, M.D.","00 40740939384","denisa.popa@clintrial.ro",{"facility":832,"status":38,"city":833,"state":11,"zip":834,"country":783,"countryCode":784,"cosmosGeoPoint":835,"geoPoint":839,"contacts":11},"Spital de Pneumologie dr Lavinia Davidescu Oradea","Oradea","410163",{"type":45,"coordinates":836},[837,838],21.91833,47.0458,{"lat":838,"lon":837},{"facility":841,"status":97,"city":842,"state":11,"zip":843,"country":783,"countryCode":784,"cosmosGeoPoint":844,"geoPoint":848,"contacts":849},"AI Clinical Research","Sibiu","550082",{"type":45,"coordinates":845},[846,847],24.15,45.8,{"lat":847,"lon":846},[850],{"name":851,"role":32,"phone":852,"phoneExt":11,"email":853},"Mihai Petriu, M.D.","(+40) 741177848","dr.mihai.petriu@gmail.com",{"facility":855,"status":97,"city":856,"state":11,"zip":857,"country":858,"countryCode":859,"cosmosGeoPoint":860,"geoPoint":864,"contacts":865},"PANACEUM s.r.o.","Košice","040 01","Slovakia","SK",{"type":45,"coordinates":861},[862,863],21.25802,48.71441,{"lat":863,"lon":862},[866],{"name":867,"role":32,"phone":868,"phoneExt":11,"email":869},"Lenka Barbierek, M.D.","00421 552 023 249","Dr.barbierik@gmail.com",{"facility":871,"status":97,"city":856,"state":11,"zip":857,"country":858,"countryCode":859,"cosmosGeoPoint":872,"geoPoint":874,"contacts":875},"Vseobecna ambulancia pre dospelych",{"type":45,"coordinates":873},[862,863],{"lat":863,"lon":862},[876],{"name":877,"role":32,"phone":878,"phoneExt":11,"email":879},"Elena Adamkovicova, M.D.","00421 904 435 935","adamkovicova@yahoo.com",{"facility":881,"status":38,"city":882,"state":11,"zip":883,"country":858,"countryCode":859,"cosmosGeoPoint":884,"geoPoint":888,"contacts":11},"Pulmo s.r.o.,","Prešov","080 01",{"type":45,"coordinates":885},[886,887],21.2355,48.99923,{"lat":887,"lon":886},{"facility":890,"status":38,"city":891,"state":11,"zip":892,"country":858,"countryCode":859,"cosmosGeoPoint":893,"geoPoint":897,"contacts":11},"Plucna ambulancia Hrebenar S.R.O.","Spišská Nová Ves","5201",{"type":45,"coordinates":894},[895,896],20.56153,48.94464,{"lat":896,"lon":895},{"facility":899,"status":38,"city":900,"state":11,"zip":901,"country":858,"countryCode":859,"cosmosGeoPoint":902,"geoPoint":906,"contacts":11},"Alergia s. r. o.","Topoľčany","955 01",{"type":45,"coordinates":903},[904,905],18.16712,48.56361,{"lat":905,"lon":904},{"facility":908,"status":38,"city":909,"state":11,"zip":910,"country":911,"countryCode":912,"cosmosGeoPoint":913,"geoPoint":917,"contacts":11},"Panthera Biopartners","Enfield","EN3 4GS","United Kingdom","UK",{"type":45,"coordinates":914},[915,916],-0.08497,51.65147,{"lat":916,"lon":915},{"facility":908,"status":38,"city":919,"state":11,"zip":920,"country":911,"countryCode":912,"cosmosGeoPoint":921,"geoPoint":925,"contacts":11},"Glasgow","G51 4TF",{"type":45,"coordinates":922},[923,924],-4.25763,55.86515,{"lat":924,"lon":923},{"facility":927,"status":38,"city":928,"state":11,"zip":929,"country":911,"countryCode":912,"cosmosGeoPoint":930,"geoPoint":934,"contacts":11},"Velocity High Wycombe","High Wycombe","HP11 2QW",{"type":45,"coordinates":931},[932,933],-0.74934,51.62907,{"lat":933,"lon":932},{"facility":936,"status":38,"city":937,"state":11,"zip":938,"country":911,"countryCode":912,"cosmosGeoPoint":939,"geoPoint":943,"contacts":11},"4 Medical Clinical Solutions (4MCS)","London","IG1 4HP",{"type":45,"coordinates":940},[941,942],-0.12574,51.50853,{"lat":942,"lon":941},{"facility":936,"status":38,"city":945,"state":11,"zip":946,"country":911,"countryCode":912,"cosmosGeoPoint":947,"geoPoint":951,"contacts":11},"Manchester","M27 8FF",{"type":45,"coordinates":948},[949,950],-2.23743,53.48095,{"lat":950,"lon":949},{"facility":953,"status":38,"city":954,"state":11,"zip":955,"country":911,"countryCode":912,"cosmosGeoPoint":956,"geoPoint":960,"contacts":11},"FutureMeds Liverpool","Metropolitan Borough of Wirral","CH62 6EE",{"type":45,"coordinates":957},[958,959],-3.10501,53.37616,{"lat":959,"lon":958},{"facility":908,"status":38,"city":962,"state":11,"zip":963,"country":911,"countryCode":912,"cosmosGeoPoint":964,"geoPoint":968,"contacts":11},"Preston","PR2 9QB",{"type":45,"coordinates":965},[966,967],-2.70452,53.76282,{"lat":967,"lon":966},{"facility":908,"status":38,"city":970,"state":11,"zip":971,"country":911,"countryCode":912,"cosmosGeoPoint":972,"geoPoint":976,"contacts":11},"Rochdale","OL11 4AU",{"type":45,"coordinates":973},[974,975],-2.1552,53.61766,{"lat":975,"lon":974},{"facility":908,"status":38,"city":978,"state":11,"zip":979,"country":911,"countryCode":912,"cosmosGeoPoint":980,"geoPoint":984,"contacts":11},"Sheffield","S2 5FX",{"type":45,"coordinates":981},[982,983],-1.4659,53.38297,{"lat":983,"lon":982},{"facility":908,"status":38,"city":986,"state":11,"zip":987,"country":911,"countryCode":912,"cosmosGeoPoint":988,"geoPoint":992,"contacts":11},"York","YO24 4LJ",{"type":45,"coordinates":989},[990,991],-1.08271,53.95763,{"lat":991,"lon":990},{"type":994,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100601259","symptoms-and-functions-in-patients-with-copd-and-chronic-bronchitis-switching-from-cig-to-ths-100601259",false,"NCT07108166","Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS","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)","Inclusion Criteria:\n\n* Adult, both sexes, aged ≥ 40 years.\n* Patient has read, understood, and signed the written informed consent form (ICF), which has received IEC or IRB approval.\n* Patient with body mass index (BMI) 17.6-40.0 kg\u002Fm2 and body weight \\> 50 kg (male) or \\> 40 kg (female). Checked at V1 and V2.\n* Patient has a CIG smoking history ≥ 10 years.\n* Patient has been smoking ≥ 10 commercially available and\u002For roll-your-own CIG\u002Fday 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\u002FmL. 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.\n* 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.\n* Patient agrees to be randomized into one of the two study arms. Checked at V2.\n* Patient with confirmed COPD via spirometry performed at V1 (FEV1\u002FFVC \\\u003C70%, post-bronchodilator (-BD)) and COPD severity classified by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) as GOLD 2 or 3 (30%≤ FEV1 \\\u003C 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.\n* Patient has cough frequency of ≥ 10 cough\u002Fhour 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.)\n\nExclusion Criteria:\n\n* Patient who self-report concomitant daily use of inhaled cannabis or any type of nicotine containing products other than CIG within the last year.\n* Patient with COPD (moderate or severe) exacerbation that has not resolved according to the GOLD standard (e.g., requirement of additional therapy) or investigator's discretion. Checked at V1 and V2.\n* Patient with currently active cancer or history of any cancer within the last 5 years prior to V1, except for those with basal cell carcinoma of the skin.\n* Patient with acute worsening symptoms of chronic bronchitis or other active respiratory or systemic infections that have not resolved. Checked at V1 and V2.\n* Patient with medical condition(s) that would jeopardize his(her) safety in the context of this study (e.g., safety laboratory parameters, abnormal ECG) or with a condition that would jeopardize study results (e.g., gastroesophageal reflux disease (GERD), heart failure, severe chronic lung emphysema, active symptomatic hay fever), as per Investigator's discretion. Checked at V1 and V2.\n* Patient is legally incompetent, physically, and\u002For mentally incapable of giving consent (e.g., emergency situation, under guardianship, in a social or sanitary establishment, prisoner or involuntarily incarcerated, unable to read).\n* Patient with a history of asthma.\n* Employee of the investigational site or any other party involved in the study, or their first-degree relatives (parent, child, spouse).\n* Current or former employee of the tobacco or e-cigarette industry or their 1st-degree relatives.\n* Patient with active or history of alcohol and\u002For drug abuse within the past year.\n* Patient with positive serological tests for human immunodeficiency virus (HIV) 1\u002F2, hepatitis B or C (Hep B\u002FC).\n* Patient with any concomitant issues (e.g., medical, psychiatric, and\u002For social reason) that, as per Investigator's discretion, would place the study patient at an unacceptable risk for participation in the study.\n* Patient who participated in any trial (for investigational medicine, or other type of intervention) that may have interfered with COPD disease progression and symptoms (including cough and dyspnea) within the last three months as per investigator's discretion.\n* Patient using any systemic (injectable or oral) corticosteroids (acute or chronic treatments) or oxygen therapy in the last 2 months excluding short term use for a COPD exacerbation.\n* Patient currently being treated with angiotensin-converting enzyme (ACE) inhibitors or opioids, or those who have used ACE inhibitors within 4 weeks or opioids within 1 week prior to screening. Checked at V1 and V2.\n* Patient treated with biologic therapies for COPD (e.g., Dupilumab) in the last 6 months.\n* Female patient is pregnant, breastfeeding or lactating, or anticipating becoming pregnant withing the duration of the study. Checked at V1 and V2.\n* Female of childbearing potential who is capable of getting pregnant, defined as a female patient who does not agree to use an acceptable method of effective contraception during the entire study, a female patient that is not surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months or postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year). Checked at V1 and V2.","ALL","40 Years",{"count":1005,"type":1006},290,"ESTIMATED","INTERVENTIONAL",[1009],"NA","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.",[1012,1013,1014],"COPD","Smoking","Tobacco Use","2026-06-12",{"date":1017,"type":1018},"2026-06-15","ACTUAL",{"date":1020,"type":1018},"2025-04-02",{"date":1022,"type":1006},"2026-11",{"name":5,"class":6},112]