[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-obstructive-pulmonary-disease-severe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-obstructive-pulmonary-disease-severe":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,76,104,126],{"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":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100521676","respiratory-and-cardiovascular-alterations-in-patients-with-chronic-obstructive-pulmonary-disease-100521676",false,"NCT06072690","Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease","The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Aged 40 years and older\n* Smoking index of 10 pack-years and more\n* Newly diagnosed chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 30-79 percent of predicted and forced expiratory volume in 1 second to forced vital capacity ratio (FEV1\u002FFVC) less than 70 percent of predicted.\n\nExclusion Criteria:\n\n* Active lung infection\n* Present or previously treated lung cancer\n* Alpha-1 antitrypsin deficiency\n* Diagnosed interstitial lung disease\n* Previously diagnosed asthma\n* Diagnosed chronic hypercapnic respiratory failure\n* Treatment with systemic glucocorticoids\n* Unstable ischaemic heart disease\n* Pregnancy\n* Present cardiac arrhythmias\n* Uncontrolled arterial hypertension\n* Dementia and other mental states that determine patient's inability to consent\n* Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion","ALL","40 Years",{"count":19,"type":20},80,"ESTIMATED","OBSERVATIONAL","Chronic obstructive pulmonary disease (COPD) is a lung condition characterized by chronic respiratory symptoms (dyspnoea, cough, sputum production and\u002For exacerbations) due to abnormalities of the airways (e.g. bronchitis, bronchiolitis) and\u002For alveoli (emphysema) that lead to persistent, often progressive, airflow obstruction.\n\nIt is a major cause of disability and death worldwide. Moreover, people with COPD often have cardiovascular diseases (CVDs) that are associated with increased risk for hospitalization and prolonged stay as well as all-cause and CVD-related mortality. Nevertheless, CVDs in patients with COPD are tend to be underestimated in clinical practice. Mechanisms that define the relation between COPD and cardiovascular morbidity include lung hyperinflation, hypoxia, pulmonary hypertension, systemic inflammation and oxidative stress, exacerbation, shared risk factors and COPD phenotypes. In the past years, some authors have announced that COPD treatment with dual bronchodilation may not only improve pulmonary function and quality of life, but also have a positive effect on cardiac function. However, there is a lack of studies with treatment-naïve patients that would describe the initial effect of dual bronchodilation on respiratory and cardiovascular systems. In this study we aimed to evaluate the effect of initial dual bronchodilation on the quality of life, respiratory and cardiovascular systems in patients with newly-diagnosed chronic obstructive pulmonary disease.",[24,25,26,27],"Chronic Obstructive Pulmonary Disease Moderate","Chronic Obstructive Pulmonary Disease Severe","Cardiovascular Diseases","Quality of Life",[29,30,31,32,33,34],"COPD","cardiac autonomic integrity","cardiac function","dual bronchodilation","biomarkers","quality of life","RECRUITING","2026-03-28",{"date":38,"type":39},"2026-04-02","ACTUAL",{"date":41,"type":39},"2021-04-15",{"date":43,"type":20},"2026-08-31",{"name":45,"class":46},"Lithuanian University of Health Sciences","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100535097","effect-of-high-flow-therapy-in-long-term-oxygen-therapy-100535097","NCT06247397","Effect of HIgh-flow Therapy in Long-term Oxygen Therapy","Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial","HILOT","Inclusion Criteria:\n\n* Age 40 years or older\n* Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox\n* COPD or ILD as main underlying reason for LTOT\n* Oxygen concentrator as stationary oxygen source in the home including night-time\n* Body mass index (BMI) \\\u003C 35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Current or previous treatment with home HFOT\n* Current treatment with home mechanical ventilation\n* Current treatment with home CPAP\n* Hospitalized during the last 2 weeks\n* Current smoking or contact with flames\n* Self-reported average use of the LTOT \\\u003C 15h per day (24 hours)\n* PaCO2 (breathing air at rest) \\> 8 kPa\n* Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)\n* Inability to participate in the study procedures (as judged by the staff)\n* Not eligible for continuing LTOT due to other reason (as judged by the staff)\n* Expected survival less than 3 months (as judged by the staff)","18 Years",{"count":58,"type":20},310,"INTERVENTIONAL",[61],"NA","This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).",[25,64,65],"Interstitial Lung Disease","Chronic Respiratory Failure With Hypoxia","2025-05-15",{"date":68,"type":39},"2025-05-21",{"date":70,"type":39},"2024-06-10",{"date":72,"type":20},"2028-12",{"name":74,"class":46},"Skane University Hospital",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":59,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100532435","phase-3-oral-citrulline-supplementation-in-copd-patients-with-malnutrition-100532435","NCT06212765","Oral Citrulline Supplementation in COPD Patients With Malnutrition","Effects of Oral Citrulline Supplementation on Fat-free Mass in COPD Patients With Malnutrition","CITRUS","Inclusion Criteria:\n\n* Men and women aged 50 and over\n* COPD stage 3 or 4 according to GOLD criteria\n* BMI \\\u003C 20 kg\u002Fm2 if \\\u003C 70 years old or \\\u003C 22 kg\u002Fm2 if ≥ 70 years old\n* Suspicion of sarcopenia marked by a score of 4 or more on the SARC-F questionnaire\n* Absence of severe COPD exacerbation for at least 3 months\n\nExclusion Criteria:\n\n* Main respiratory disease other than COPD\n* Daily long-term use of systemic corticosteroids (\\>6 months per year, whatever the dose)\n* Severe and end-stage renal insufficiency (creatinine clearance \\\u003C30ml\u002Fmin)\n* Patient with severe hypotension, uncontrolled hypertension (at investigator's discretion)\n* Contraindication to L-citrulline intake: VKA and\u002For cancer chemotherapy\n* Osmotic diarrhoea\n* Severe and\u002For uncontrolled progressive pathology likely to be life-threatening\n* Psychiatric pathology (schizophrenia, dementia, severe bipolar\u002Fpsychotic disorders, severe depressive syndrome)\n* Pacemaker or other implanted electronic device","50 Years",{"count":86,"type":20},60,[88],"PHASE3","Chronic obstructive pulmonary disease (COPD) is complicated by malnutrition in 20-70% of cases. In COPD, low fat-free mass is associated with a higher risk of morbidity and mortality. L-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. Oral supplementation with L-citrulline (10 g\u002Fday) in malnourished patients has shown to increase fat-free mass. The effects of L-citrulline supplementation in malnourished COPD patients are unknown.\n\nThe main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with L-citrulline (10 g\u002Fday) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (BMI \\\u003C 20 kg\u002Fm2 if \\\u003C 70 years old or \\\u003C 22 kg\u002Fm2 if ≥ 70 years old) with COPD at stages 3-4 of the GOLD classification.",[25,91],"Malnutrition",[29,93,91],"L-citrulline","NOT_YET_RECRUITING","2024-01-08",{"date":97,"type":39},"2024-01-19",{"date":99,"type":20},"2024-01-25",{"date":101,"type":20},"2026-09-25",{"name":103,"class":46},"University Hospital, Grenoble",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":114,"studyType":21,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100531323","risk-prediction-model-for-exacerbating-phenotype-in-patients-with-chronic-obstructive-pulmonary-disease-100531323","NCT06198309","Risk Prediction Model for Exacerbating Phenotype in Patients With Chronic Obstructive Pulmonary Disease","A Risk-predictive Model for Frequent Acute Exacerbation Phenotype in Patients With Severe Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for COPD of the global initiative for chronic obstructive lung diseases (GOLD 2022) and GOLD grading Ⅲ - Ⅳ (FEV1\u002FFVC\\<70%, FEV1% predicted value ≤ 50% after Bronchiectasis)\n2. Age\\>40 years old\n3. COPD stable for more than 4 weeks\n4. Short acting Bronchiectasis was not used within 24 hours before this experiment, long acting Bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month\n5. Patient informed and signed consent form\n\nExclusion Criteria:\n\n1. Asthma, active pulmonary tuberculosis, interstitial pneumonia and severe Bronchiectasis\n2. Complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease)\n3. History of chronic diarrhea or constipation\n4. History of Gastrointestinal Surgery\n5. Using probiotics or antibiotics within the past 4 weeks\n6. No history of using oral hormones or traditional Chinese medicine in the past three months\n7. Pregnancy or lactation","85 Years",{"count":113,"type":20},365,"1 Year","This study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. Based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; Construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and BP neural network models. The development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (COPD), and improve the health level of COPD patients by further searching for treatable targets.",[25],"2023-12-27",{"date":119,"type":39},"2024-01-10",{"date":121,"type":39},"2023-05-01",{"date":123,"type":20},"2027-12-01",{"name":125,"class":46},"Li An",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":59,"phases":136,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":47},"100363939","phase-2-cell-therapy-associated-with-endobronchial-valve-100363939","NCT04018729","Cell Therapy Associated With Endobronchial Valve","Bone Marrow-Derived Mesenchymal Stromal Cell Therapy Associated With Unidirectional Endobronchial Valve in Patients With Severe Pulmonary Emphysema: A Randomized Clinical Trial","CEL&VAL","Inclusion Criteria:\n\n* Diagnosis of severe heterogeneous pulmonary emphysema (at least 10% of total lung parenchyma or 25% of target lobe with density \\\u003C -950HU);\n* Heterogeneity\\> 15pp (difference of at least 15 percentage points of lung parenchyma with density greater than -950HU between the treated lobe(s) and the remaining lung on the same side)\n* Estimates of low or non-existent collateral ventilation (fissure integrity\\> 95% measured by VIDA Diagnostics or collateral ventilation measured by negative Chartis® System)\n* Total lung capacity\\> 100% of predicted\n* Residual volume\\> 175% of predicted\n* FEV1 \\\u003C50% of predicted post-bronchodilator\n* DLCO (diffusing capacity of the lungs for carbon monoxide) \\\u003C45% of predicted post-bronchodilator\n* Body Mass Index (BMI) Greater than 18Kg\u002Fm2 and less than 35Kg\u002Fm2.\n* Optimized clinical treatment\n* Daily physical activities limitation\n* Possibility of pulmonary rehabilitation\n* Preserved ventricular function (LVEF\\> 40%)\n* Cessation of smoking ≥ 4 months\n* Dyspnea MMRC ≥ 2\n\nExclusion Criteria:\n\n* Homogeneous emphysema\n* Estimated collateral ventilation observed on CT scanned by VIDA vision software (VIDA vision®, VIDA Diagnostics, Iowa-USA) - Fissure integrity on target lobe less than 75%.\n* Use of continuous systemic corticosteroid therapy\\> 20mg QD (quaque die, once a day) of prednisone (or equivalent)\n* Active lung or extra pulmonary infection\n* Coronary heart disease and\u002For severe ventricular dysfunction\n* Significant renal or hepatic disease\n* Immunosuppressive disease\n* Rheumatologic or orthopedic disease limiting physical capacity;\n* Cognitive inability to understand study procedures;\n* Impression by clinical research investigators with a lifespan of less than a year1;\n* Active smoking\n* Malignant neoplasia with estimated prognosis of survival \\\u003C2 years\n* Psychosocial problems\n* Pregnancy",{"count":135,"type":20},34,[137,88],"PHASE2","Chronic obstructive pulmonary disease (COPD) is one of the most common diseases worldwide and is considered a public health problem. The World Health Organization estimates that about 210 million people have COPD. Disease-related mortality is more than 3 million, representing 5% of all deaths, 90% of this mortality being concentrated in middle- and low-income countries. COPD can be subdivided into chronic bronchitis and emphysema. Emphysema, the focus of this project, is histologically defined by the permanent increase of the distal air spaces to the terminal bronchioles associated with the destruction of the alveolar septa in the lung. Approximately two-thirds of adult men and a quarter of women (most without dysfunction) will have well-defined emphysema, but often of limited extent.\n\nMesenchymal stem cells (MSCs) have anti-inflammatory, anti-fibrotic, microbicide and repair potential. Regarding COPD, several authors have concentrated efforts in the investigation of the relationship between the severity of the condition and the various sources of adult stem cells. Apparently the lungs have a high chemotactic effect in relation to adult stem cells, since several studies have evidenced a high implantation (6-20%) of stem cells derived from bone marrow, administered systemically, in the pulmonary tissue of receptors. Therefore, MSCs has been tested in different lung diseases have no effective treatment, such as pulmonary fibrosis, acute respiratory distress syndrome, asthma, COPD positive results, such as reduction of fibrosis, reduction of proliferation inflammatory cells and cytokines, reduction of infectious processes and recovery of the histological changes caused by pulmonary emphysema.\n\nBased on these findings, the purpose of this project is to evaluate the safety and efficacy of endoscopic administration of bone marrow stem cells in patients with severe homogeneous emphysema and evaluating the feasibility, efficacy and safety of this procedure.",[25],"2022-12-12",{"date":142,"type":39},"2022-12-14",{"date":144,"type":39},"2019-11-19",{"date":146,"type":20},"2029-04-30",{"name":148,"class":46},"Hospital de Clinicas de Porto Alegre"]