[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"emphysema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:emphysema":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,42,80,108,138,170,198,219,243,275,299,323,346,366,393,418,459,479,510,534,554,577,608,629,655],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100645394","division-of-the-interlobar-fissure-in-patients-who-do-not-respond-to-endobronchial-lung-volume-reduction-100645394",false,"NCT07682168","DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction","DIVIDE","Inclusion criteria\n\n1. Age \\\u003C or equal 75 years\n2. Stable COPD with less than or equal to 10mg prednisolone daily\n3. Nonsmoking for 3 months prior to screening and willing to not smoke during the study duration\n4. Willing and able to complete protocol required study follow-up assessments and procedures\n5. Fit for thoracoscopy under general anaesthesia (surgical and anaesthetic assessment)\n6. Recent (\\\u003C 18 months) endobronchial lung volume reduction (EBLVR) and lack of response defined by:\n\n   1. Persistent symptomatic dyspnoea (mMRC \\>2) which in the patient's view is no better than baseline\n   2. Absence of target lobar collapse with any residual aeration apparent on imaging\n   3. Persistence of (6a) and (6b) following post procedure StratX CT analysis and revisional bronchoscopy.\n\nExclusion criteria\n\n1. Fissure completeness \\\u003C90% on pre EBLVR StratX (i.e less than 10% of fissure to be divided)\n2. Chartis positive for collateral ventilation or not performed\u002Fnot satisfactory at initial EBLVR\n3. Quantitative perfusion of target lobe \\>25% of total on SPECT assessment.\n4. Previous lung surgery or pleurodesis on the target side for LVR.\n5. Clinically significant bronchiectasis -greater than 4 tablespoons mucus per day.\n6. More than 3 COPD exacerbation episodes in the last year.\n7. Evidence of hypercapnia (pCO2 \\>7KPa) - ABG to be performed on admission for index procedure\n8. Clear evidence of pulmonary hypertension (systolic pulmonary arterial pressure \\>45mmHg) or evidence or right ventricular dysfunction as determined by a recent echocardiogram (\\\u003C12mo)\n9. Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (\\\u003C12mo)\n10. Myocardial infarction within 6 months of screening.\n11. Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.","ALL","18 Years","75 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","Surgical division of fissure is hypothesized to be safe and feasible. However, there is no preparatory study to test this hypothesis. It is logically expected that morbidity from the procedure could be less than standard LVRS and in preparation to a side-to-side trial of fissure division versus standard LVRS, a safety and feasibility study is required to test this hypothesis and inform future trial design.",[27,28,29],"Chronic Obstructive Pulmonary Disease (COPD)","Emphysema","Lung Volume Reduction Surgery","NOT_YET_RECRUITING","2026-06-26",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":21},"2026-08",{"date":38,"type":21},"2028-01",{"name":40,"class":41},"Rocco Bilancia","OTHER_GOV",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100602109","a-multi-center-study-testing-a-new-implant-for-adults-with-severe-emphysema-100602109","NCT07119229","A Multi Center Study Testing a New Implant for Adults With Severe Emphysema","A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema","IAB-2","Inclusion Criteria:\n\n1. Signed Informed Consent.\n2. Diagnosis of COPD\u002Femphysema.\n3. At least 22-years of age.\n4. 18 ≤ BMI ≤ 32.\n5. 6-minute walk Distance between 100-meters and 400-meters at baseline exam.\n6. Stable disease with less than 10-mg prednisone (or equivalent) daily\n7. Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.).\n8. FEV1 between 15% and 50% of predicted value at baseline exam.\n9. FEV1\u002FFVC \\\u003C70%.\n10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation \\\u003C-950 HU, as determined by CT core lab.\n11. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (\\\u003C -950HU) as determined by CT core lab.\n12. RV \\> 175% of predicted value.\n13. mMRC score ≥ 2.\n\nExclusion Criteria:\n\n* 1\\. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment..\n\n  2\\. α-1 Antitrypsin deficiency 3. Women of child-bearing potential. 4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening.\n\n  5\\. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention.\n\n  6\\. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening.\n\n  7\\. Clinically significant mucus production or chronic bronchitis. 8. Myocardial Infarction or unstable \u002F uncontrolled congestive heart failure within 6-months of screening.\n\n  9\\. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR).\n\n  10\\. Clinically significant bronchiectasis. 11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days.\n\n  12\\. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \\>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram (completed within the last 3-months prior to screening visit). Note: the echocardiogram is not a required screening procedure.\n\n  13\\. Suspected malignant pulmonary nodule or other lung cancer. 14. HRCT collected per CT scanning protocol within the last 6-months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:\n  1. Large bullae encompassing greater than 30% of either lung\n  2. Insufficient landmarks to evaluate the CT study using the software as it is intended\n  3. All lobes are less than 25% parenchyma diseased (\\\u003C -950 HU) 15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant.\n\n     16\\. TLC \\\u003C 100% predicted at screening. 17. DLCO \\\u003C 15% or \\> 50% of predicted value at screening. 18. PaCO2 \\> 50 mm Hg at screening. 19. PaO2 \\\u003C 45 mm Hg in room air at screening. 20. Plasma cotinine level \\> 13.7 ng\u002Fml or carboxyhemoglobin (arterial or ear lobe capillary) \\>2.5% at screening.\n\n     21\\. Current diagnosis of substance abuse disorder. 22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder.\n\n     23\\. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.","22 Years",{"count":52,"type":21},60,[24],"A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD\u002Femphysema works, and how safe it is.",[56,28,57],"Emphysema or COPD","COPD",[59,60,61,62,63,64,65,66,67],"IAB","Stent","Emphysema treatment","emphysema study","COPD treatment","COPD study","EBV alternative","Lung volume reduction","Lung hyperinflation treatment","RECRUITING","2026-06-02",{"date":71,"type":34},"2026-06-03",{"date":73,"type":34},"2026-03-25",{"date":75,"type":21},"2027-11",{"name":77,"class":78},"Pulmair Medical, Inc.","INDUSTRY",3,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100599580","a-trial-of-the-implantable-artificial-bronchus-50-flex-in-patients-with-severe-emphysema-100599580","NCT07086339","A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema","A Two Center Trial of the Implantable Artificial Bronchus 50 Flex (IAB 50 Flex) in Patients With Severe Emphysema","IAB-3","Inclusion Criteria:\n\n1. Signed Informed Consent\n2. Diagnosis of COPD\u002Femphysema\n3. At least 22-years of age\n4. 18 ≤ BMI ≤ 32\n5. 6-minute walk Distance of between 100 - and 400 meters\n6. Stable disease with less than 10-mg prednisone (or equivalent) daily\n7. Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.).\n8. FEV1 between 15% and 45% of predicted value at baseline exam\n9. FEV1\u002FFVC \\\u003C70%\n10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab.\n11. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab.\n12. RV \\> 175% of predicted value.\n13. mMRC score ≥ 2\n\nExclusion Criteria:\n\n1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment\n2. α-1 Antitrypsin deficiency\n3. Women of child-bearing potential\n4. More than 2 COPD exacerbation episodes requiring hospitalization in the last year prior to screening\n5. Any COPD exacerbations requiring hospitalization within 6-weeks of planned intervention\n6. Two or more instances of pneumonia episodes requiring hospitalization in the last year prior to screening\n7. Clinically significant mucus production or chronic bronchitis\n8. Myocardial Infarction or unstable \u002F uncontrolled congestive heart failure within 6-months of screening\n9. Prior lung transplant, LVRS, bullectomy, lobectomy or endoscopic lung volume reduction (ELVR)\n10. Clinically significant bronchiectasis\n11. Unable to safely discontinue anti-coagulants or platelet activity inhibitors for 7-days\n12. Uncontrolled pulmonary hypertension (systolic pulmonary arterial pressure \\>45 mm Hg) or evidence or history of cor pulmonale as determined by recent echocardiogram\n13. Suspected malignant pulmonary nodule or other lung cancer\n14. HRCT collected per CT scanning protocol within the last 6 months of screening date and evaluated by clinical site personnel using 3D segmentation software shows:\n\n    * Large bullae encompassing greater than 30% of either lung\n    * Insufficient landmarks to evaluate the CT study using the software as it is intended\n    * All lobes are less than 25% parenchyma diseased (\\\u003C -950 HU).\n15. Any cardiac comorbidity which the PI believes would compromise the safety of the patient after an IAB implant\n16. TLC \\\u003C 100% predicted at screening\n17. DLCO \\\u003C 15% or \\> 50% of predicted value at screening\n18. PaCO2 \\> 50 mm Hg at screening\n19. PaO2 \\\u003C 45 mm Hg in room air at screening\n20. Plasma cotinine level \\> 13.7 ng\u002Fml or carboxyhemoglobin (arterial or ear lobe capillary) \\>2.5% at screening.\n21. Current diagnosis of substance abuse disorder.\n22. Current diagnosis of any of the following: Major Depressive Disorder (MDD), Schizoaffective Disorder, Schizophrenia, Borderline Personality Disorder, Bipolar Disorder\n23. Any other conditions, which, in the opinion of the Investigator, would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.",{"count":89,"type":21},20,[24],"A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema",[57,28],[59,94,28,57,95,96,97,63,61,98,99],"Pulmair Medical","Lung Volume Reduction","Interventional Pulmonology","Pulmonology","lung conditions","Lung disease","2026-06-01",{"date":71,"type":34},{"date":103,"type":34},"2026-02-04",{"date":105,"type":21},"2027-12",{"name":77,"class":78},2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"100638475","lung-disease-and-flna-mutations-100638475","NCT07592637","Lung Disease and FLNA Mutations","Prevalence and Characteristics of Lung Disease Associated With FLNA Mutations: a Multicenter Cross-sectional Study","FLN-Air","Inclusion Criteria:\n\n* Patient with an FLNA mutation (or gene alteration)\n* Patient who has given written consent to participate in the trial\n* Socially insured patient\n* Patient willing to comply with all study procedures and duration\n\nExclusion Criteria:\n\n* Patient refused or unable to give informed consent\n* Administrative reasons: inability to receive information, inability to participate in the entire study, lack of coverage by the social security system,\n* Pregnant or breastfeeding women\n* Patient under guardianship\n* Persons deprived of liberty","99 Years",{"count":118,"type":21},70,[24],"Some sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with FLNA variants. This transversal multicentric study aimed to describe the frequency of emphysema in patients carrying an FLNA variation. Patients with FLNA variations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests, a cardiac ultrasound and a chest scan. The primary endpoint is to describe emphysema's frequency in patients carrying FLNA variation. The other objectives are to describe emphysema's features in these patients, the prevalence of pulmonary hypertension and to describe their lung function abnormalities. The final goal is to confirm the association between unexplained emphysema and FLNA mutation.",[28],[28,123,124,125,126],"FLNA","Filaminopathies A","Pulmonary hypertension","Asthma","2026-05-20",{"date":129,"type":34},"2026-05-26",{"date":131,"type":21},"2026-09",{"date":133,"type":21},"2029-03",{"name":135,"class":136},"University Hospital, Lille","OTHER",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100557073","clinical-ultrasonographic-assessment-of-pulmonary-emphysema-100557073","NCT06533371","Clinical-ultrasonographic Assessment of Pulmonary Emphysema","Assessment of Pulmonary EmphySema: the Clinical -ULtrasonographic APproach to chronIc Obstructive Pulmonary Disease","ESCULAPIO","Inclusion Criteria:\n\n* outpatients in follow-up for chronic obstructive pulmonary disease, in stable conditions, with computed tomographic evidence of panlobular or paraseptal emphysema.\n* Inpatients, admitted to the hospital due to acute exacerbation of chronic obstructive pulmonary disease, with computed tomographic evidence of panlobular or paraseptal emphysema.\n* Subjects who participate in the screening program for lung cancer with computed tomographic evidence of panlobular or paraseptal emphysema.\n* Outpatients \u002F Inpatients with suspected\u002Fknown lung cancer and computed tomographic evidence of panlobular or paraseptal emphysema.\n* Patients able to give written informed consent.\n\nExclusion Criteria:\n\n* pregnancy.\n* Pediatric population.\n* Patients unable to express written informed consent.",true,{"count":148,"type":21},1628,[24],"The goal of this clinical trial is to identify correlations among data deriving from lung ultrasonographic (LUS) and tomographic evaluations of patients with panlobular or paraseptal emphysema, to improve the comprehension of acoustic information derived from ultrasound evaluation.\n\nThe main question it aims to answer is: what are the correlations between thoracic ultrasonographic patterns and peripheral parenchymal changes evaluated by high resolution computed tomography (HRCT) of the chest, in patients affected with variable degree of panlobular or paraseptal emphysema? Researchers will compare LUS patterns observed in: 1) COPD patients with CT evidence of panlobular or paraseptal emphysema, 2) subjects participating in the screening program for lung cancer with CT evidence of panlobular or paraseptal emphysema, and 3) patients with suspected\u002Fknown lung cancer undergoing with CT evidence of panlobular or paraseptal emphysema, with the ones obtained from healthy volunteers and subjects who participate in the screening program for lung cancer with no evidence of emphysema.\n\nParticipants will undergo LUS evaluation with both clinical and research scanners. Patients will be assessed in supine position with the arms extended above the head. The position is the same in which chest CT scans will be performed. LUS assessment will be performed using commercially available linear probes.\n\nFinally, all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo respiratory oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD.",[28,152],"Pulmonary Emphysema",[154,28,155,156,157,158,159],"Pulmonary emphysema","Lung ultrasound","Oscillometry","Quantitative analysis","Chest computed tomography","Early diagnosis","2026-05-19",{"date":162,"type":34},"2026-05-22",{"date":164,"type":34},"2024-09-04",{"date":166,"type":21},"2027-02-28",{"name":168,"class":136},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",4,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100618051","phase-4-phase-4-double-blind-study-evaluating-the-response-on-computed-tomography-ct-lung-density-decline-rates-of-respreeza--zemaira-weekly-for-3-years-in-adults-with-alpha1-antitrypsin-deficiency-aatd-100618051","NCT07326592","Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza \u002F Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)","A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® \u002F Zemaira® Weekly Intravenous Infusions Administered Over 3 Years as Longterm Maintenance Therapy in Adult Subjects With Emphysema Related to Alpha1 Antitrypsin Deficiency","Inclusion Criteria:\n\n* • Age greater than or equal to (\\>=) 18 and less than or equal to (\\\u003C=) 65 years at the time of providing written informed consent.\n* • Confirmed diagnosis of emphysema related to AATD with either the PiZZ, PiZ(null), or Pi(null\u002Fnull) genotype with documented serum AAT levels less than (\\\u003C) 11 micrometer (μM) (or \\\u003C 50 mg\u002FdL \\[milligram\u002Fdeciliter\\]) at any time before the first administration of CE1226 on Day 1 (Baseline).\n\nExclusion Criteria:\n\n* • Participants should not have acute illness or pulmonary exacerbation within 6 weeks before the first administration of CE1226 on Day 1 (Baseline).\n* • Participants should not have previously received gene therapy for AATD at any point.\n* • Participants with liver disease secondary to AATD.","65 Years",{"count":179,"type":21},270,[181],"PHASE4","This is a multicenter, parallel-group, double-blind, randomized phase 4 study designed to identify the optimal dose of CE1226 (2 active doses) to slow disease progression as assessed by reduced rates of annual lung density decline in alpha-1 antitrypsin (AAT) deficient participants over 3 years as compared with the marketed dose 60 milligrams per kilogram (mg\u002Fkg).",[184,185,28],"Alpha1 Antitrypsin Deficiency","Alpha1-Proteinase Inhibitor Deficiency",[187,188],"Progressive Emphysema","Chronic Pulmonary Disease","2026-05-14",{"date":191,"type":34},"2026-05-15",{"date":193,"type":21},"2026-07-20",{"date":195,"type":21},"2033-09-15",{"name":197,"class":78},"CSL Behring",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":137},"100518050","analysing-peripheral-skeletal-muscle-function-before-and-after-endobronchial-valve-treatment-100518050","NCT06025500","Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment","Analysing cEllular Bioenergetics aNd Structural aDaptations in the qUadriceps Muscle befoRe and After endobroNChial Valve treatmEnt","ENDURANCE","Inclusion Criteria:\n\n* Patient is scheduled for a bronchoscopic lung volume treatment using one-way endobronchial valves;\n* Patient read, understood and signed the Informed Consent Form.\n\nExclusion Criteria:\n\n* Inability to perform a cycle ergometry test;\n* Contraindications for undergoing a magnetic resonance imaging scan (e.g. claustrophobia, implanted cardiac devices);\n* Body length \\>190cm;\n* Any anticoagulant therapy;\n* COPD exacerbation 4 weeks prior to testing.",{"count":20,"type":21},"OBSERVATIONAL","Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence of peripheral muscle dysfunction, which can have significant clinical consequences, including decreased exercise capacity, reduced quality of life, and even a higher mortality rate. Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with one-way endobronchial valves (EBV) is a minimally invasive intervention which improves exercise capacity and physical activity in patients with severe emphysema. This positive effect is also related to weight gain and alterations in body composition. The physiologic and structural adaptations of skeletal muscle function after EBV treatment has never been investigated before.\n\nObjective: To investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in response to EBV treatment.\n\nStudy design: A single center, prospective clinical trial with a single-arm pretest-posttest design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies before and after placement of EBVs.\n\nStudy population: Patients with severe emphysema who are scheduled to undergo EBV treatment.\n\nMain study parameters\u002Fendpoints: The difference in quadriceps phosphocreatine concentration (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during progressive exercise, and recovery rate will be measured by 31P-MRS to assess the physiological effect of EBV treatment on skeletal muscle function and its bioenergetics. Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber type composition, mitochondrial density, master regulators of muscle oxidative programming, and mitochondrial respiration before and after EBV treatment.",[28],"2026-04-24",{"date":212,"type":34},"2026-04-29",{"date":214,"type":34},"2024-10-01",{"date":216,"type":21},"2026-12-01",{"name":218,"class":136},"University Medical Center Groningen",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":228,"studyType":207,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100385712","strive-post-market-registry-study-100385712","NCT04302272","STRIVE Post-Market Registry Study","The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema","Inclusion Criteria:\n\n1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.\n2. Subjects must understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.\n2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.\n3. Subjects who have incomplete screening or baseline data.",{"count":227,"type":21},150,"3 Years","This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.",[28],[28,232,233],"Chronic obstructive pulmonary disease (COPD)","Spiration valve system","2026-04-23",{"date":210,"type":34},{"date":237,"type":34},"2021-10-09",{"date":239,"type":21},"2029-10",{"name":241,"class":78},"Olympus Corporation of the Americas",14,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100584623","bronchoscopic-release-of-air-trapped-in-hyperinflated-emphysematous-lung---study-3-100584623","NCT06891755","Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3","BREATHE-3","* Inclusion Criteria\n\n  1. Subject is at least 40, but not older than 84, years of age.\n  2. Subject has body mass index (BMI) of between 18 and 32, inclusive.\n  3. Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline.\n  4. Subject has mMRC score ≥ 2.\n  5. Subject can walk ≥100 meters in 6 minutes.\n  6. Subject has ≥25% emphysema destruction score in each lung as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT core lab.\n  7. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (-910HU) as determined by the CT core lab.\n  8. Subject has bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted.\n  9. Subject has pre-procedure post-bronchodilator FEV1\u002F FVC \\\u003C 0.70.\n  10. Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.\n  11. Subject has pre-procedure post-bronchodilator RV\u002FTLC ≥ 0.55.\n  12. Subject has pre-procedure DLCO ≥ 20%.\n  13. Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.\n  14. Subject has not actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 4 months, and agrees to smoking cessation during the study.\n  15. Subject has received preventative vaccinations (or documented clinical intolerance) against potential respiratory infections, including pneumococcus, influenza, RSV (subjects \\>60 yrs. old) and Covid-19, consistent with local recommendations or policy.\n  16. In the opinion of the Primary investigator, subject can undergo bronchoscopy under general anesthesia and is able to adhere to the study follow-up schedule.\n  17. Subject has provided written informed consent.\n* Exclusion Criteria\n\n  1. Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).\n  2. Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).\n  3. Subject has bilateral lobar emphysematous destruction scores of \\>70% percent of voxels with \\\u003C-950 Hounsfield units on thin slice inspiratory CT, as determined by the CT core lab.\n  4. Subject has arterial or capillary blood on room air: PaCO2 \\> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).\n  5. Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations\u002Frespiratory infections in the year prior to enrollment.\n  6. Subject has had previous lung volume reduction surgery, lobectomy, pneumonectomy, segmentectomy, bullectomy, lung transplantation, vapor, glue, or other pulmonary device implant (unless the device has been removed at least 3 months prior to consent).\n  7. Subject has known or suspected history of pulmonary arterial hypertension (e.g. PASP \\> 50mmHg on echocardiogram in absence of confirmation on a right heart catheterization or mPAP \\> 25mmHg on a right heart catheterization).\n  8. Subject has presence of a giant bulla (≥ 30% of hemithorax).\n  9. Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and\u002For chronic bronchitis as their primary diagnosis.\n  10. Subject has presence of suspicious radiological abnormalities on HRCT scan such as pulmonary nodule\u002Finfiltrate that in judgement of the PI, may require intervention during course of the study.\n  11. Subject has clinically significant bronchiectasis (\\>4 TBS \u002F 45mL mucus production\u002Fday, per subject estimate) influencing subject's COPD symptoms.\n  12. Subject has unresolved lung cancer.\n  13. Subject has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy (documented LVEF ≤40%), or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \\>8%), uncontrolled hypertension (diastolic BP \\>110 mmHg or systolic \\>200 mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy.\n  14. Subject is on anticoagulant or antiplatelet therapy for cardiovascular indications and, at the discretion of the Primary investigator, is unable to have anticoagulants withheld for a bronchoscopy procedure per institution's standard of care.\n  15. Subject has invasive mechanical ventilator dependency.\n  16. Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration.\n  17. Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium).\n  18. Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis.\n  19. Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia.\n  20. Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms.\n  21. Subject has within the 2 years prior to consent, had a severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and\u002For invasive mechanical ventilation.","40 Years","84 Years",{"count":253,"type":21},250,[24],"The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?",[57,28],[258,57,28,259,260,261,262,263,264,265],"Apreo","BREATHE System","Hyperinflation","Air-trapping","Apreo BREATHE Airway Scaffold","BREATHE Implant","Airway Scaffold","Apreo Health","2026-04-22",{"date":210,"type":34},{"date":269,"type":34},"2025-07-15",{"date":271,"type":21},"2029-12-31",{"name":273,"class":78},"Apreo Health, Inc.",22,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":286,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":137},"100623975","ventilation-perfusion-discrepancy-index-versus-conventional-anatomic-physiologic-assessment-for-target-lung-lobe-selection-in-endobronchial-valve-placement-a-multicenter-randomised-controlled-trial-100623975","NCT07403617","Ventilation-Perfusion Discrepancy Index Versus Conventional Anatomic-Physiologic Assessment for Target Lung Lobe Selection in Endobronchial Valve Placement: A Multicenter, Randomised Controlled Trial","Inclusion Criteria:\n\n* Clinical and radiological evidence of emphysema\n* Nonsmoking for 4 months prior to screening interview\n* BMI less than 35 kg\u002Fm2\n* Stable on current medication regimen\n* Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value\n* Residual Volume less than 175% predicted (determined by body plethysmography)\n* Little or no collateral ventilation (CV-) as determined using the Chartis System\n\nExclusion Criteria:\n\n* Had two or more hospitalizations over the last year for a COPD exacerbation\n* Had two or more hospitalizations over the last year for pneumonia\n* Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy\n* Had a heart attack or congestive heart failure within the last 6 months\n* Have heart arrhythmia\n* Is alpha-1 antitrypsin deficient",{"count":282,"type":21},285,[24],"The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs).\n\nThe main question it aims to answer is:\n\n· Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan?\n\nIf there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT\u002FChartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe.\n\nParticipants will:\n\n* Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V\u002FQ SPECT\u002FCT scan to calculate the VQDI.\n* Have their collateral ventilation status checked using the Chartis system during bronchoscopy.\n* Be randomly assigned to one of the two target lobe selection strategies.\n* Receive EBV placement in the selected lobe.\n* Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.",[28],[287,288,28,289],"Endobronchial Lung Volume Reduction","Ventilation-Perfusion Discrepancy Index","Chronic Obstructive Pulmonary Disease","2026-02-05",{"date":292,"type":34},"2026-02-11",{"date":294,"type":21},"2026-04",{"date":296,"type":21},"2028-10",{"name":298,"class":136},"China-Japan Friendship Hospital",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":137},"100597526","implementation-of-a-sarcopenia-clinic-to-diagnose-and-treat-skeletal-muscle-loss-due-to-copd-100597526","NCT07059637","Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD","Inclusion Criteria:\n\n1. COPD exacerbation as the primary cause for inpatient hospitalization OR secondary diagnosis of COPD exacerbation with acute respiratory failure as the primary diagnosis.\n2. Patients must have CT (Computed Tomography) imaging performed during their admission and evidence of low skeletal muscle mass determined by CT imaging of the pectoralis muscle\n3. Age \\> 40 years old.\n4. Spirometry diagnosed COPD with FEV1\u002FFVC ratio \\\u003C0.70 with at least moderate obstruction (FEV1; forced expiratory volume in 1 second \\\u003C80%).\n5. Patients must have smoked at least 10 pack years and may be current or former smokers.\n\nExclusion Criteria:\n\n1. History of other comorbid lung disease (i.e. interstitial lung disease, asthma).\n2. Currently being evaluated or already listed for lung transplant.\n3. Active malignancy.\n4. Significant comorbid end organ failure defined as congestive heart failure (ejection fraction\\\u003C40%), end stage renal disease requiring dialysis, or cirrhosis (based on radiologic imaging).",{"count":306,"type":21},80,[24],"Sarcopenia, or skeletal muscle loss, impacts up to 40% of COPD patients and is a major cause for morbidity and mortality. Despite the high clinical significance of sarcopenia in COPD, the diagnosis remains elusive because accurate measures of skeletal muscle are not tested during routine clinical care. The goal is to use evidence-based strategies to diagnose and treat sarcopenia due to COPD. The multidisciplinary team includes a pulmonologist, pharmacist, COPD nurse, and COPD coordinator. The investigators anticipate that the approach will improve clinical outcomes for COPD patients with sarcopenia as compared to standard of care visits in ambulatory COPD clinics. The investigators will determine if the approach improves skeletal muscle mass and function, and also improves clinical outcomes related to frequency of hospitalization or ED (Emergency Department) visits, COPD exacerbations, and mortality.",[57,28,310],"Sarcopenia",[57,312,313],"emphysema","sarcopenia","2025-10-28",{"date":316,"type":34},"2025-10-30",{"date":318,"type":34},"2025-10-10",{"date":320,"type":21},"2027-12-01",{"name":322,"class":136},"The Cleveland Clinic",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":146,"sex":16,"minAge":330,"maxAge":4,"enrollmentInfo":331,"targetDuration":333,"studyType":207,"phases":4,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":137},"100080733","emphysema-research-registry-and-biosample-repository-100080733","NCT00307281","Emphysema Research Registry and Biosample Repository","Emphysema Research Registry; Screening Study and Genetic Testing","Inclusion Criteria:\n\n* Patients would be required to have COPD based on at least one of the following: clinical history, pulmonary function results, or radiographic results.\n\nExclusion Criteria:\n\n* none","21 Years",{"count":332,"type":21},3000,"2 Years","The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC Health System) provides patients with any type of breathing or lung disorder a full range of diagnostic and therapeutic services. The Emphysema\u002FCOPD Research Center (ECRC) is a specialty clinic, within this center, that attempts to advance the understanding of emphysema and to evaluate new therapies for patients with emphysema. The Emphysema Research Registry will enable pulmonary research physicians to: 1) gather information and create a research registry of people who have been diagnosed with emphysema; 2) utilize this research registry with the purpose of conducting research that attempts to advance the understanding of emphysema and to evaluate new therapies; and, 3) use the research registry to identify potential candidates for future research programs. These aims will be achieved by the collection of DNA (genetic material)for analysis and storage in addition to pulmonary function tests and other medical information.",[28,289,336],"Chronic Bronchitis","2025-09-24",{"date":339,"type":34},"2025-09-25",{"date":341,"type":34},"2000-08",{"date":343,"type":21},"2030-07",{"name":345,"class":136},"University of Pittsburgh",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":137},"100600469","endobronchial-silicone-valve-for-patients-with-emphysema-100600469","NCT07097896","Endobronchial Silicone Valve for Patients With Emphysema","Bronchoscopic Lung Volume Reduction With Endobronchial Silicone Valve for Patients With Emphysema: a Randomised Controlled Trial",{"count":353,"type":21},147,[24],"The purpose of this research is to compare the efficacy and safety between endobronchial silicone valve and endobronchial valve in bronchoscopic lung volume reduction in patients with severe emphysema.",[28],[287,28,289],"2025-07-30",{"date":360,"type":34},"2025-08-01",{"date":362,"type":21},"2025-07",{"date":364,"type":21},"2027-07",{"name":298,"class":136},{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":107},"100502669","exploring-novel-biomarkers-for-emphysema-detection-100502669","NCT05825261","Exploring Novel Biomarkers for Emphysema Detection","Exploring Novel Biomarkers for Emphysema Detection: the ENBED Study","ENBED","Inclusion Criteria:\n\n* Adults aged over 18 years\n* current respiratory smptoms (any dyspnea, cough or sputum)\n* spirometry confirmed diagnosis of a non-fully reversible airflow obstruction, defined as a post bronchodilator Forced Expiratory Volume at one second\u002FForced Vital Capacity (FEV1\u002FFVC ratio) \\\u003C 0.7 and\u002For emphysemateus abnormalities on CT imaging.\n* presence of risk factors or causes associated with COPD\n* chest CT scan performed in the past 12 months prior to inclusion to the study\n* able to understand, read and write Dutch language\n\nExclusion Criteria:\n\n* acute exacerbation of COPD within 8 weeks of start of the study\n* comorbidities affecting speech or breathing coordination (neuromuscular disease, CVA\\\u003C BMI \\> 40)\n* comorbidities affecting speech characteristics of dyspnea (severe heart failure, interstitial lung disease)\n* comorbidities affecting respiratory system including but not exclusive to asthma or cystic fibrosis\n* comorbidities that significantly interfere with interpretation of speech (audio signals), such as Parkinson's disease, bulbar palsy, or vocal cord paralysis.\n* Medical history of lobectomy or endoscopic lung volume reduction (ELVR)\n* inability to carry out a capnography recording.\n* investigator's uncertainty about the willingness or ability of the patients to comply with the protocol requirements.\n* participation in another study involving investigational products. Participation in observational studies is allowed.",{"count":375,"type":21},200,"The goal of this clinical trial is to evaluate whether voice or capnometry, alone or in combination with other (non invasive) biomarkers can be used to detect emphysema on chest CT-scan in people with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:\n\n• Can a machine-learning based algorithm be developed that can classify the extent of emphysema on chest CT scan from patients with COPD, based on voice and\u002For capnometry.\n\nParticipants will:\n\n* perform different voice-related tasks\n* perform capnometry twice (before\u002Fafter exercise)\n* perform a light exercise task between tasks ( 5-sit-to-stand test)\n* undergo one venipuncture",[378,28],"Copd",[380,381,312,382,383],"vocal biomarkers","speech","capnometry","chest CT","2025-06-10",{"date":386,"type":34},"2025-06-13",{"date":388,"type":34},"2023-09-07",{"date":390,"type":21},"2026-05",{"name":392,"class":136},"Maastricht University",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":400,"maxAge":18,"enrollmentInfo":401,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100576693","utilising-hull-lung-health-study-data-to-investigate-the-performance-of-tidalsense-diagnostic-algorithms-to-identify-copd-and-pre-copd-among-participants-in-the-frontier-programme-100576693","NCT06788613","Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme.","Beyond-FRONTIER: Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme","All Hull Lung Health Study participants that attend a one-stop diagnostic clinic appointment as part of the FRONTIER Programme (NHS Lung Health Check) will be eligible for inclusion in this study.\n\nProspective consent provided for use of data for research purposes and for future contact as part of the Hull Lung Health Study\n\nInclusion criteria:\n\n* Participants in the Hull Lung Health Check Programme (ever smokers aged 55-75 and registered with a Hull GP) with one or more of the following symptoms during their lung health check:\n* Breathlessness\n* Cough\n* Bronchitis\n* Recurrent infections\n* AND\u002FOR evidence of Emphysema on Low Dose CT\n\nExclusion criteria:\n\n-Existing COPD diagnosis noted at the time of their Lung Health Check or new COPD diagnosis since Lung Health Check attendance AND prescribed appropriate COPD therapy.","55 Years",{"count":402,"type":21},1200,"Aim: To investigate the potential for N-Tidal to improve COPD diagnosis and enable detection of pre-COPD\\*.\n\nObjectives:\n\n1. To assess the performance of TidalSense COPD Diagnostic Algorithms for COPD diagnosis in a real-world, head-to-head comparison with post-bronchodilator spirometry among FRONTIER programme participants.\n2. To assess the performance of TidalSense COPD Diagnostic Algorithms for identification of pre-COPD.\n3. Evaluate TidalSense COPD Diagnostic Algorithms ability to identify those at risk of developing COPD within 1-year.\n\nAim: Explore the blood biomarker profile among FRONTIER Programme participants to explore a potential role in early COPD identification.\n\nObjectives:\n\n1. Investigate the blood biomarker profile (obtained from the Hull Lung Health Study data) of people with i) confirmed COPD, ii) pre-COPD, and iii) no evidence of COPD.\n2. Explore a potential role for blood biomarkers in COPD diagnostics.\n\n   * Pre-COPD is defined, as per the GOLD Report 2023, as individuals who have respiratory symptoms and\u002For other detectable structural and\u002For functional abnormalities in the absence of airflow obstruction on forced spirometry. For the purpose of this study, respiratory symptoms will be classified as a CAT score \\> 10 during FRONTIER clinic attendance and presence of emphysema on low-dose CT considered evidence of structural lung abnormalities",[57,56,28],[57,406,407,408],"Hull Lung Health","TidalSense","N-tidal","2025-05-30",{"date":411,"type":34},"2025-05-31",{"date":413,"type":21},"2025-08",{"date":415,"type":21},"2026-09-30",{"name":417,"class":78},"Chiesi UK",{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":146,"sex":16,"minAge":17,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":428,"conditions":429,"keywords":444,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":137},"100556693","identification-of-multiple-pulmonary-diseases-using-volatile-organic-compounds-biomarkers-in-human-exhaled-breath-100556693","NCT06528418","Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath","Exploration and Study on the Identification of Various Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath","Inclusion Criteria:\n\n* Males or females, age must be 18 years old or above.\n* Patients must meet the CT imaging diagnostic criteria for different lung diseases, and patients must be able to provide electronic versions of CT image data.\n* Patients must have a clear clinical diagnosis.\n* All participants must sign a written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Individuals with a history of cancer other than lung disease.\n* Individuals who have undergone organ transplants or non-autologous (allogeneic) bone marrow or stem cell transplants.\n* Individuals with other severe organic diseases or mental illnesses.\n* Individuals with metabolic diseases such as diabetes, hyperlipidemia, etc.\n* Any other condition that researchers deem unsuitable for participation in this clinical trial.","100 Years",{"count":427,"type":21},10000,"The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules. This model aims to accurately diagnose mutiple pulmonary diseases. The primary objectives it strives to accomplish are:\n\n1. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose several common pulmonary diseases.\n2. To assess the diagnostic accuracy of an exhaled breath VOC-assisted diagnostic artificial intelligence (AI) model in diagnose more pulmonary diseases.",[430,431,57,432,433,434,435,436,437,28,438,439,440,441,442,443],"Lung Cancer","Lung Infection","Bronchitis","Pulmonary Fibrosis","Pulmonary Embolism","Pulmonary Arterial Hypertension","Pulmonary Tuberculosis","Pulmonary Abscess","Lung Injury","Cystic Fibrosis of the Lung","Bronchial Asthma","Bronchiectasis","Interstitial Lung Disease","Preserved Ratio Impaired Spirometry",[445,446,447,448,449],"Pulmonary Disease","Volatile Organic Compounds","Human Exhaled Breath","micro Gas Chromatography-photoionisation","detector (μGC-PID) system","2025-03-23",{"date":452,"type":34},"2025-03-26",{"date":454,"type":34},"2024-06-30",{"date":456,"type":21},"2027-06-30",{"name":458,"class":78},"ChromX Health",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":137},"100542923","safety-and-efficacy-of-endobronchial-valve-for-bronchoscopic-lung-volume-reduction-surgery-a-prospective-pilot-study-100542923","NCT06349174","Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study","Inclusion Criteria:\n\n* 1\\. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;\n* 2\\. Age range from 40 to 85 years old (including 40 and 85 years old);\n* 3\\. BMI ≤ 35kg\u002Fm2;\n* 4\\. 15% ≤ FEV1% pred ≤ 45%;\n* 5\\. TLC\\>100% pred, RV\\>140% pred, and DLCO\u002Fred% ≥ 20%;\n* 6\\. 100m ≤ 6WMD ≤ 500m after rehabilitation training;\n* 7\\. Quit smoking for more than 4 months;\n* 8\\. The evaluation result of pulmonary bypass ventilation function is negative;\n* 9\\. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.\n\nExclusion Criteria:\n\n* 1\\. Being pregnant or breastfeeding;\n* 2\\. PaCO2\\>50mmHg and\u002For PaO2\\\u003C45mmHg;\n* 3\\. Obvious bronchiectasis or other infectious lung diseases;\n* 4\\. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;\n* 5\\. Coagulation dysfunction, platelet count\\\u003C60e+09\u002FL;\n* 6\\. Myocardial infarction or congestive heart failure within the past 24 weeks;\n* 7\\. Previous lobectomy, LVRS or lung transplantation;\n* 8\\. Anticoagulant therapy that cannot be stopped before surgery;\n* 9\\. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\\>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;\n* 10\\. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;\n* 11\\. Pulmonary nodules that require intervention;\n* 12\\. Patients participating in other clinical trials;\n* 13\\. Individuals with other contraindications to bronchial operations;\n* 14\\. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.","85 Years",{"count":467,"type":21},10,[24],"The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are:\n\nDoes self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves?\n\nParticipants will:\n\nundergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves.\n\nreceive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.",[28,289],"2025-02-07",{"date":473,"type":34},"2025-02-10",{"date":475,"type":34},"2024-04-11",{"date":477,"type":21},"2025-03-31",{"name":298,"class":136},{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":493,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":509},"100566457","the-reduce-eu-study---endobronchial-thermal-liquid-ablation-etla-for-the-treatment-of-emphysema-100566457","NCT06655428","The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema","The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)","Inclusion Criteria:\n\n* Age ≥ 40 years old\n* Diagnosis of COPD with FEV1\u002FFVC less than 0.7 post-bronchodilation\n* Post-bronchodilator Forced Expiratory Volume (FEV1) ≥ 20% and ≤ 49% of predicted value\n* Total lung capacity (TLC) ≥ 100% predicted\n* Residual volume (RV) ≥ 175% predicted\n* 6 Minute Walk Distance (6MWD) ≥ 140 meters\n* Dyspnea scoring ≥ 1 on the modified Medical Research Council scale (mMRC)\n* Blood gas values of PCO2 ≤ 55 mmHg; PO2 ≥ 45 mmHg on room air\n* Optimized medical management (consistent with GOLD guidelines) as confirmed by the Investigator\n* Non-smoking for 3 months prior to study enrollment, as confirmed by lab testing\n* Participant must engages in physical exercise beyond activities of daily living (i.e., a walking program, pulmonary rehabilitation) on n a regular basis for more than 6 weeks prior to enrollment and agree to continue the activity throughout study participation\n* Participant must live within approximately 1 hour of the study hospital, or live within 1 hour of adequate regional care, or be willing to remain in the hospital for at least five days post-procedure\n* Vaccinated for COVID-19, pneumococcus, and influenza (per European Union and Member State guidelines) or documented clinical intolerance or documented patient refusal\n* Cognitively able to provide written informed consent and willing to comply with study requirements\n* Severe emphysematous lung subsegments eligible for ETLA treatment\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\\u003C 16 kg\u002Fm\\^2 or ≥ 33 kg\u002Fm\\^2\n* DLCO \\\u003C 20% predicted\n* Chronic bronchitis as defined by cough and sputum production for at least 3 months per year for two consecutive years, in the absence of other conditions that can explain these symptoms\n* 75ml or greater sputum production per day most days of the week\n* Greater than two hospitalizations for COPD exacerbations and\u002For pneumonia in the 12 months prior to enrollment\n* Diagnosis of asthma that is confirmed according to the Global Initiative for Asthma (GINA) guidelines\n* Prior lung volume reduction via endobronchial valves(s), coil(s), vapor and\u002For polymer. Patients whose valves have been removed \\> 3 months previously can be treated if a baseline bronchoscopy reveals no airway obstruction or obvious tissue granulation and the reason for valve removal was not for complications e.g., Pneumonia, severe exacerbation, or pneumothorax.\n* Pulmonary hypertension\n* Alpha-1 antitrypsin deficiency\n* Uncontrolled diabetes mellitus\n* Prior heart or lung transplant\n* Myocardial infarction or stroke within the 12 months of enrollment\n* Diagnosis of heart failure\n* Heart failure requiring hospitalization, within 6 months prior to enrollment\n* History of bleeding disorders or enhanced predisposition to bleeding\n* History of severe\u002Fmassive hemoptysis defined as \\>200ml of blood loss in \\\u003C 24 hours\n* Unable to discontinue anti-coagulants or platelet inhibitors (acetylsalicylic acid \\[ASA\\]and non-ASA, including low dose) for at least 7 days prior to each procedure (or as per physician discretion based on the specific agent) and for at least 6 weeks after each procedure\n* Daily systemic steroids equivalent to \\> 15mg prednisolone\n* Immunosuppressive drugs, such as for the treatment of cancer, autoimmune disease, or prevention of tissue\u002Forgan rejection\n* Pregnant, lactating, or women of childbearing potential that plan to become pregnant within the study duration\n* Currently enrolled in another trial studying an experimental treatment\n* Any disease or condition likely to limit survival to less than one year\n* Concomitant illnesses or medications that may pose a significant increased risk for complications following treatment with ETLA\n* Any condition that would interfere with evaluation or completion of the study including study assessments and procedures, including bronchoscopy.\n* Active aspergillus infection\n* Clinically significant bronchiectasis as determined by the Investigator\n* Radiological evidence of bronchiectasis in target region(s) and\u002For cystic radiological bronchiectasis in any region of the lungs\n* Clinically significant pulmonary fibrosis\n* Lung nodule not proven stable unless proven to have benign pathology\n* Large bulla (defined as \\> 1\u002F3 volume of a lung)\n* Prior Lung Volume Reduction Surgery (LVRS), bullectomy, or lobectomy\n* The remaining lung tissue NOT targeted for ETLA treatment is too highly diseased\n* Active respiratory infection or recent respiratory infection with resolution \\\u003C 4 weeks prior to screening or procedure\n* Recent COPD exacerbation within \\\u003C 6 weeks prior to screening or procedure",{"count":487,"type":21},30,[24],"The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety.\n\nParticipants will:\n\n* Have up to two ETLA procedures\n* Complete five clinic follow-up visits and two virtual follow-up visits.",[56,28,491,57,492],"Emphysema, Pulmonary","COPD (Chronic Obstructive Pulmonary Disease)",[95,494,495,496,497,498,499,500],"bronchoscopic lung volume reduction","ETLA","BTVA","LVR","Lung Disease, obstructive","Chronic Obstructive Lung Disease","Respiratory Tract Disease","2025-01-27",{"date":503,"type":34},"2025-01-28",{"date":505,"type":34},"2025-01-10",{"date":390,"type":21},{"name":508,"class":78},"Morair Medtech, LLC",7,{"id":511,"slug":512,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":533},"100541670","zephyr-valve-japan-post-marketing-surveillance-100541670","NCT06332885","Zephyr Valve Japan Post-Marketing Surveillance","Inclusion Criteria:\n\n1. Patient is deemed eligible for BLVR using Zephyr Valve, as determined by their treating physician in accordance with Japanese guidelines and approved instruction for use. These include:\n\n   * Recent respiratory rehabilitation completed within the last 6 months\n   * Not actively smoking (for at least 4 months)\n   * TLC ≥ 100%\n   * RV ≥ 175%\n   * FEV1 15-45% post-bronchodilator\n   * 6MWD 100-500 m\n   * mMRC score ≥ 2\n   * No coagulation disorder\n   * No evidence of active respiratory infection\n2. Patient has little to no collateral ventilation (CV-) between the target and ipsilateral lobe as confirmed by Chartis prior to undergoing BLVR.\n3. Patient is willing and able to provide informed consent to allow data collection.\n\nExclusion Criteria: None",{"count":517,"type":21},140,"This is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using Zephyr Endobronchial Valve at up to 20 centers across Japan and followed for 12 months.",[28,57,520],"Severe Emphysema",[522,523],"Bronchoscopic lung volume reduction","Zephyr Valves","2024-12-09",{"date":526,"type":34},"2024-12-13",{"date":528,"type":34},"2024-03-12",{"date":530,"type":21},"2028-03-31",{"name":532,"class":78},"Pulmonx Corporation",17,{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":465,"enrollmentInfo":541,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":137},"100420948","characterizing-matrix-metalloproteinase-12-mmp12-in-sputum-100420948","NCT04761393","Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum","Characterizing Mmp12 In Sputum And Its Relationship To Emphysema And Inflammatory Endotypes","Inclusion Criteria (COPD):\n\n* ≥40 years of age\n* Current or ex-smokers with a \\>10 pack year smoking history\n* Have a post-bronchodilator forced expired volume in 1 second (FEV1)\u002Fforced expired vital capacity (FVC) ratio of \\\u003C70% and a post-bronchodilator FEV1 value from ≥30% predicted (GOLD 1, 2 and 3), (Global Initiative for Obstructive Lung disease)\n* Have a radiologist confirmed pulmonary emphysema diagnosis based on CT\n\nInclusion criteria for normal controls:\n\n* No clinically significant medical condition or a history of asthma, COPD, cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms.\n* No current or past smoking history\n* Have a post-bronchodilator FEV1\u002FFVC ratio of \\>70%\n\nExclusion Criteria:\n\nAny potential subject who meets any of the following criteria will be excluded from participating in the study:\n\n* Patients with other non-COPD airway diseases\n* Patients with very severe COPD (FEV1\\\u003C30% predicted)\n* Patients with an intercurrent exacerbation\n* Patients with life expectancy less than 3 months\n* Pregnant or breastfeeding\n* Undergoing immunomodulatory or biologic treatment\n* Use of systemic steroids in the last month\n* Hospitalization in the last 12 months due to exacerbation\n* Known cardiovascular comorbidity under treatment or with hospitalizations of this cause in the last year\n* That they cannot perform spirometry\n* Active malignancy\n* Realization of lung surgery during the study period\n* History of alcohol and drug abuse that prevents compliance with follow-up\n* History of bronchial thermoplasty\n* Participating in another study concomitantly\n* MRI Related: patients who have implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, artificial limb, metallic fragments of foreign body, shunt, surgical staples (including clips or metallic sutures and\u002For ear implants).",{"count":542,"type":21},45,"The hypothesis is that in patients with emphysema, a high MMP12 sputum and\u002For blood level correlates with airspace enlargement and with increased sputum Th2 immune biomarkers.",[28],"2024-11-18",{"date":547,"type":34},"2024-11-20",{"date":549,"type":34},"2022-11-29",{"date":551,"type":21},"2025-01",{"name":553,"class":136},"McMaster University",{"id":555,"slug":556,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":11,"sex":16,"minAge":400,"maxAge":18,"enrollmentInfo":562,"targetDuration":250,"studyType":207,"phases":4,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":107},"100569141","deprecap-lung-cancer-screening-programme-by-ldct-for-patients-with-copd-or-emphysema-100569141","NCT06690385","DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With COPD or Emphysema.","Registry of Patients Included in the DEPRECAP (Lung Cancer Screening Porgramme by Low-dose Computed Tomography for Patients With Chronic Obstructive Pulmonary Disease (COPD) or Emphysema.","DEPRECAP","Inclusion Criteria:\n\n* Current or former smokers (\\>15 years of abstinence) with a cumulative smoking exposure of \\> 30 pack-years\n* Diagnosis of COPD according to the GOLD guidelines and\u002For emphysema identified by LDCT and\u002For a carbon monoxide diffusing capacity (DLCO) lower than 80% of predicted (as per the Global Lung Function Initiative (GLI) equations)\n\nExclusion Criteria:\n\n* Individuals with a recent history of cancer (except non-melanoma skin cancer or carcinoma in situ) as well as those with other medical conditions that posed a significant risk of death were excluded from the study.",{"count":563,"type":21},1998,"The DEPRECAP (Early detection of lung cancer) study is an ongoing, prospective, longitudinal, multicenter lung cancer screening program that recruited individuals with COPD or emphysema from the pulmonary clinics of Fundación Jiménez Díaz University Hospital and Villalba General Hospital, in Madrid, Spain.\n\nThe aim of this observational study is to determine the scientific evidence needed to study the benefit and potential effects of lung cancer screening in this group of patients and to determine the long-term effects of the intervention in reducing the high mortality rates associated with late-stage lung cancer diagnosis in a very high-risk population, to address under-diagnosis of COPD and to promote smoking cessation. This leads to the creation of a registry with clinical, radiological, functional data and biological samples for future studies in this cohort of patients to provide the scientific evidence needed to study the benefit and potential effects of screening for lung cancer and other tobacco-related pathologies diagnosed by Low-dose CT (LDCT)",[430,57,28],[567,568,57,28],"Lung cancer screening","Low-dose computed CT","2024-11-13",{"date":571,"type":34},"2024-11-15",{"date":573,"type":34},"2014-01-14",{"date":569,"type":21},{"name":576,"class":136},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz",{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":16,"minAge":585,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":589,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":607},"100403734","surgical-compared-to-bronchoscopic-lung-volume-reduction-in-patients-with-severe-emphysema-100403734","NCT04537182","Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema","Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial","SINCERE","Inclusion Criteria:\n\n* Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within \\\u003C 6 month of screening, CT scan within \\\u003C 4 months of screening)\n* Age ≥ 30 and ≤ 80 years\n* Body Mass Index (BMI) ≥ 16, but ≤ 35 kg\u002Fm2\n* Non-smoking for 3 months prior to screening interview\n* Patient is able to understand and willing to sign a written informed consent document.\n\nExclusion Criteria:\n\n* FEV1 more than 50% predicted\n* TLC less than 100 % predicted, RV less than 175% predicted, RV\u002FTLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively\n* PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)\n* PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)\n* Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)\n* Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is \\\u003C 95%)\n* 6-minute walking distance ≥ 470m\n* More than two COPD exacerbation episodes requiring hospitalization in the last year\n* More than two instances of pneumonia episodes in the last year\n* Unplanned weight loss ≥ 10% within 90 days prior to enrollment\n* Pulmonary hypertension as evidenced by Delta Psyst RV-RA \\> 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.\n* Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)\n* History of exercise-related syncope\n* Myocardial infarction or congestive heart failure within 6 months of screening\n* Clinically significant arrhythmias that might put the patient at risk in regard to the interventions\n* Prior LVR (any method), bullectomy, or lobectomy\n* Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons\u002Fday.\n* Pulmonary nodule requiring surgery\n* Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days\n* Patients with a life expectancy of less than one year","30 Years","80 Years",{"count":588,"type":21},120,[24],"The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.",[28],[593,594,595,596,597],"LVRS","BLVR","endobronchial valves","heterogeneous empyhsema","non-heterogeneous emphysema","2024-05-07",{"date":600,"type":34},"2024-05-08",{"date":602,"type":34},"2020-09-01",{"date":604,"type":21},"2028-03",{"name":606,"class":136},"Isabelle Opitz, Professor, MD",6,{"id":609,"slug":610,"hasResults":11,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":146,"sex":16,"minAge":585,"maxAge":4,"enrollmentInfo":614,"targetDuration":615,"studyType":207,"phases":4,"briefSummary":616,"conditions":617,"keywords":619,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":626,"locationsCount":107},"100305969","site-and-mechanisms-of-expiratory-airflow-limitation-in-copd-emphysema-and-asthma-copd-overlap-100305969","NCT03263130","Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap","Inclusion Criteria:\n\n* asthma- copd overlap\n* emphysema in smokers with smoking history \\> 15 pack years\n* COPD\u002F bronchitis and bronchiectasis in smokers with smoking history\n* \\>15 pack years\n\nExclusion Criteria:other pulmonary or systemic diagnosis\n\n* non smokers\n* any other pulmonary diagnosis\n* pulmonary fibrosis",{"count":52,"type":21},"2 Months","The purpose of this cross-sectional, observational study is to evaluate the site and mechanism(s) for expiratory airflow limitation in chronic, treated, current or former smokers (\\>15 pack years) with COPD, Emphysema, and Asthma-COPD Overlap with mild to severe expiratory airflow limitation. Treatment may include short and long acting inhaled beta2agonists, short and long acting inhaled muscarinic receptor antagonists, inhaled and or oral corticosteroid, oral antibiotic, supplemental oxygen, and PDE type 4 inhibitor. In some cases, the patient may have had a history of asthma preceding the development of COPD (Asthma COPD Overlap).",[618,28],"COPD, Emphysema, Asthma COPD Overlap",[618],"2023-10-25",{"date":622,"type":34},"2023-10-27",{"date":624,"type":34},"2017-01-01",{"date":320,"type":21},{"name":627,"class":628},"Gelb, Arthur F., M.D.","INDIV",{"id":630,"slug":631,"hasResults":11,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":146,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":636,"targetDuration":638,"studyType":207,"phases":4,"briefSummary":639,"conditions":640,"keywords":642,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":137},"100270686","copd-patient-powered-research-network-100270686","NCT02803242","COPD Patient-Powered Research Network","COPD PPRN","Inclusion Criteria:\n\n* 18 years or older that says yes to one of the following:\n* COPD diagnosis\n* Current or former smoker\n* Family history of respiratory disease\n* Symptomatic of respiratory disease\n\nExclusion Criteria:\n\n* Non-English speaking",{"count":637,"type":21},75000,"15 Years","The COPD Patient-Powered Research Network (COPD PPRN) is a patient research registry with the goal of enrolling 75,000 or more COPD patients and those at risk who are willing to share their heath information over several years and participate in research. The COPD PPRN has built an online platform to allow volunteers to enroll electronically, complete surveys, be contacted about studies they qualify for and become connected to COPD resources. The goal of the registry is to speed research to find better treatments for COPD and ultimately a cure.",[641,499,28,336],"Chronic Obstructive Pulmonary Disorder",[643,312,644,645],"copd","bronchitis","bronchiectasis","2022-03-08",{"date":648,"type":34},"2022-03-10",{"date":650,"type":4},"2014-08",{"date":652,"type":21},"2030-01",{"name":654,"class":136},"COPD Foundation",{"id":656,"slug":657,"hasResults":11,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":11,"sex":16,"minAge":250,"maxAge":465,"enrollmentInfo":663,"targetDuration":665,"studyType":207,"phases":4,"briefSummary":666,"conditions":667,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":137},"100377864","kingston-chronic-obstructive-pulmonary-disease-copd-multidimensional-long-term-follow-up-cohort-100377864","NCT04200079","Kingston Chronic Obstructive Pulmonary Disease (COPD) Multidimensional Long Term Follow up Cohort","Kingston COPD Cohort","KCOCO","Inclusion Criteria:\n\n1. Patients ages between 40-85 years old.\n2. Smoking history of at least 10 pack year history\n3. Active of former smokers\n4. Diagnosis of COPD according to the GOLD definition (4): post bronchodilator spirometry FEV1\u002FFVC ≤0.70, including those with other associated respiratory diseases like asthma, bronchiectasis, stable lung cancer or Interstitial Lung Disease.\n5. Ability to perform all study procedures (complete pulmonary function tests, six minute walking test (6MWT) and chest computed tomography) and provide\u002Fsign informed consent.\n\nExclusion Criteria:\n\n1. Patients not willing to sign the consent form\n2. Patients with a life expectancy of less than 3 yrs.\n3. Patients in palliative care.\n4. Patients with chronic airway obstruction ie: FEV1\u002FFVC≤0.70 of other etiology and without a smoking history of less than 10 packs year history.\n5. Patients unable ort not able to perform the pulmonary function test, the 6MWT or the chest CT.",{"count":664,"type":21},400,"10 Years","Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic complex patient. Their follow up can sometimes be difficult and challenging (1). There are patients with recurrent exacerbations that put an enormous burden on health care resources (2). They also have multiple comorbidities (3) that can sometimes make their management difficult. In an attempt to coordinate all these efforts KGH, HDH and Providence Care have numerous essential resources to take care of COPD patients like the nurse navigators, nurse practitioners and the pulmonary rehabilitation program. These programs provide an excellent support to the clinical activity of Respirologists and other health care providers.\n\nRationale: The main rationale for the development of the Kingston COPD cohort is to translate that highly demanding clinical activity in a teaching and research oriented activity that could be used by clinicians, medical students, residents and fellows. Having a guideline complained established protocol in COPD patients that are usually follow at KGH and HDH could help in not only in unified the way COPD patients are seeing (preserving the importance of the personalized approach) but most importantly established a multidimensional (clinical, physiological, radiological, laboratory) database. This could help know not only the results of our clinical activity but also have a long term (\\>5yrs) database for clinical research projects in collaboration with national and international research groups. Therefore this proposal is important because it will help translate our busy daily clinical work in a highly productive teaching and research activity.",[57,28],"2021-09-07",{"date":670,"type":34},"2021-09-14",{"date":672,"type":34},"2020-01-14",{"date":674,"type":21},"2030-12-31",{"name":676,"class":136},"Dr. Juan Pablo de Torres Tajes"]