[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Philip Morris Products S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":19,"type":20},290,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"COPD","Smoking","Tobacco Use","RECRUITING","2026-06-12",{"date":32,"type":33},"2026-06-15","ACTUAL",{"date":35,"type":33},"2025-04-02",{"date":37,"type":20},"2026-11",{"name":39,"class":40},"Philip Morris Products S.A.","INDUSTRY",112,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100627053","assessment-of-hphc-exposure-in-smokers-switching-to-thstp18-with-different-device-variants-100627053","NCT07443631","Assessment of HPHC Exposure in Smokers Switching to THS\u002FTP18 With Different Device Variants","A Randomized, Controlled, Open-label, 6 Parallel Arms Study to Assess Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) of Cigarette (CIG) Smoke in Adult Smokers Switching to Tobacco Heating Systems (THS\u002FTP18) With Different Device Variants as Compared to Continuing CIG Smoking","Inclusion Criteria:\n\n* Participant has signed the ICF and understands the information provided in it.\n* Participant is male or female and between 21 and 65 years old (inclusive).\n* Participant has been a smoker for at least 2 years prior to the screening visit and is willing to switch to THS and TP18.\n* Participant has smoked on average ≥10 commercially available CIGs\u002Fday over the last 30 days. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng\u002FmL).\n* Participant does not plan to quit smoking within the next three months.\n* Participant is available for the entire study period and willing to comply with the study procedures, including product use assignments and periods of abstinence from any nicotine\u002Ftobacco-containing products, and willing to adhere to a standardized diet (during confinement period and during overnight stays on Day 30 and Day 60).\n\nExclusion Criteria:\n\n* As per the Investigator's judgment, the participant cannot participate in the study for any reason other than medical (e.g., psychological, social reason).\n* Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).\n* Participant has a health condition which requires medication or any other clinically relevant finding based on available assessments from the Screening period (e.g., safety panel, pulmonary function test, vital signs, physical examination, ECG, and medical history), as determined by the Principal Investigator or designee.\n* Participant experienced within 30 days prior to screening\u002Fadmission a body temperature \\>37.9°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.).\n* According to the Investigator's judgment, the participant has medical conditions that require or will require medical intervention (e.g., initiation of treatment, surgery, hospitalization) during the study period, which may interfere with study participation and\u002For study results.\n* Participant uses medication that aids in smoking cessation.\n* Participant experiences difficulty with venipuncture and\u002For poor venous access.\n* Participant has a hemoglobin level \\\u003C 11.0 g\u002FdL for females and \\\u003C 12.0 g\u002FdL for males at the Screening visit.\n* Participant has a positive nitrite urinary test at screening or on admission day (Day -2)\n* Participant has donated blood or received whole blood or blood products within the past 3 months.\n* BMI \\\u003C 18.5 kg\u002Fm2 or ≥ 32.0 kg\u002Fm2.\n* Positive serology test for HIV 1\u002F2, HBV, or HCVa.\n* Participant has a positive alcohol breath test and\u002For has a history of alcohol disorder that could interfere with their participation in the study.\n* The participant has a positive urine drug test.\n* Participant or one of their family members is a current or former employee of the tobacco industry, manufacturing or distributing e-cigarettes or other nicotine\u002Ftobacco-containing products.\n* A participant or a family member is an employee of the investigational site or of any other parties involved in the study.\n* Participant has participated in another clinical study within 30 days or within a period equivalent to five half-lives of the investigational product from that study, whichever is longer. .\n* Participant has been previously screened or enrolled in this study (unless they are alternate subjects).\n* Female participant is pregnant (does not have negative pregnancy tests at screening and\u002For at admission) or is breastfeeding.\n* For women of childbearing potential only and males: participant does not agree to use an acceptable method of effective contraception.",true,"21 Years","65 Years",{"count":53,"type":20},108,[23],"This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to smokers who continue smoking CIG after 5 days of confinement period, followed by 2 days of pharmacokinetic (PK) period of single use of THS\u002FTP18 and CIG, and followed by an ambulatory period.",[27],[58],"HPHC","2026-04-30",{"date":61,"type":33},"2026-05-01",{"date":63,"type":33},"2026-02-19",{"date":65,"type":20},"2026-12-18",{"name":39,"class":40},1,""]