[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"copd-exacerbation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:copd-exacerbation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,46,70,90,116,142,165,189,214,242,269,298,320,348,371,397,428,455,483,507,534],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100428540","multidisciplinary-management-of-severe-copd-100428540",false,"NCT04860375","Multidisciplinary Management of Severe COPD","Longitudinal, Open Label, Clinical Trial Evaluating the Effectiveness of Detailed Phenotyping and Subsequent Multidisciplinary Management of Both COPD and Multimorbidity in Patients With COPD After a Hospitalization Due to Acute Exacerbation of COPD.","Inclusion Criteria:\n\n1. Male or female patients, aged ≥40 years.\n2. Smokers or ex-smokers (≥10 pack-year).\n3. Prior hospitalization because of progressively worsening dyspnea (associated or not with increased cough and sputum, and or sputum purulence), with a clinically suspected diagnosis of exacerbations of COPD that prompt the discharging physician to refer the patient to the COPD Center.\n4. Signed informed concent form.\n\nExclusion Criteria:\n\n1. Presenting to the hospital for similar symptoms, which are not defined by the clinicians as suspected exacerbations of COPD, because of alternative diagnoses not related to patients with COPD (e.g., chest wall trauma, neurological disorders, sepsis, cancer and anemia).\n2. Already enrolled in other studies perceived to interfere with this protocol.\n3. In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis).\n4. Unable to comply with study procedures and follow-ups in the opinion of the Investigator (e.g., other severe diseases with short life expectancy or who make it impossible for the patients to participate into the study, evidence of alcohol or drug abuse, dementia, severe psychiatric disorder).\n5. Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring specific cardiology ICU.\n6. Diagnosed stroke, dementia, degenerative neurological disorders or psychiatry disorders requiring specialized care.\n7. At the discretion of the recruiting clinician would not be able to be considered for the study.","ALL","40 Years","100 Years",{"count":20,"type":21},110,"ESTIMATED","INTERVENTIONAL",[24],"NA","Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and\u002For alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and was associated with a significant increase of disability-adjusted life years. In Sweden the prevalence of COPD is approximately 8% bringing the annual total estimated cost for society of 9.1 billion SEK. About 1\u002F3 of patients with COPD undergo periods of acute worsening of respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1 year) and long-term mortality (\\> 50% at 5 years) and high risk of re-hospitalization. Because patients with COPD often suffer concomitant disorders that significantly worsen their health status and vital prognosis, the management of the patients is not only the management of COPD but must include identification and treatment of other concomitant chronic diseases.\n\nAccurate diagnosis, assessment of severity, and long-term interdisciplinary management of both COPD and concomitant chronic diseases in patients with COPD could be associated with a decreased number of hospitalizations and deaths, improved quality of life and decreased health care utilization in the following 3 years. This longitudinal study will evaluate the effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD and multimorbidity in patients.\n\nThis is a prospective, open label, cohort study using design of intervention and registries data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years of recruitment period) and 1-year data collection from the National Registries. The study will compare number of rehospitalizations from all causes of patient recruited after a hospitalization due to acute exacerbations of COPD to control patients included from the Swedish Airway Register (SAR). The selection of the control population within the SAR is based on risk score matching. At the first visit a thorough individual's assessment will be performed. The assessment includes information about demographics, COPD and exacerbations, medical history, comorbidities, vital parameters, blood and sputum tests and assessment of quality of life. Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol. The last visit will take place at 5th year after the study start. The \"end of study\" is defined as last visit of the last subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs will be combined with the data from SAR and complemented with data from Swedish National Registries.",[27,28],"Copd","COPD Exacerbation",[30,31,32],"COPD","Multidisciplinary management","COPD exacerbation","RECRUITING","2026-05-11",{"date":36,"type":37},"2026-05-14","ACTUAL",{"date":39,"type":37},"2021-09-22",{"date":41,"type":21},"2029-06-30",{"name":43,"class":44},"Vastra Gotaland Region","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100635566","early-detection-of-copd-exacerbations-using-home-monitoring-device-100635566","NCT07554352","Early Detection of COPD Exacerbations Using Home Monitoring Device","A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.","Inclusion Criteria:\n\n* Age \\>21 years.\n* Physician-diagnosed COPD at least 6 months prior to screening visit.\n* Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.\n* Free of exacerbation for 1 month before enrollment.\n\nExclusion Criteria:\n\n* Unable or willing to sign an informed consent.\n* Unable to complete the 6-minute walk test due to physical or mental health conditions.\n* Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.\n* Pregnancy\n* Study clinician determines that the patient is unable or unwilling to comply with all study procedures.","21 Years",{"count":55,"type":21},30,"OBSERVATIONAL","The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age \\>21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.",[28],"NOT_YET_RECRUITING","2026-04-21",{"date":62,"type":37},"2026-04-28",{"date":64,"type":21},"2026-05",{"date":66,"type":21},"2027-05",{"name":68,"class":69},"RespirAI US Inc","INDUSTRY",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":45},"100502650","predicting-adverse-outcomes-using-machine-learning-of-copd-patients-in-hong-kong-100502650","NCT05825014","Predicting Adverse Outcomes Using Machine Learning of COPD Patients in Hong Kong","Inclusion Criteria:\n\n* ≥40 years\n* Patients are discharged from 2016 -2022\n* Discharge Diagnosis: Using the Discharge Diagnosis ICD Codes found in the Primary Diagnosis to determine if a patient has COPD\n* Validated against Spirometry results (for patient with a spirometry reading):\n\nSpirometry reading taken from anytime point before. Patient should have Post FEV1\u002FFVC ratio of \\\u003C 0.7 in any one of the spirometry readings. If Post FEV1\u002FFVC is not available, we will check if patients have a Pre FEV1\u002FFVC value, and will also include patients with Pre FEV1\u002FFVC ratio of \\\u003C 0.7 in any one of the spirometry readings.\n\nExclusion Criteria:\n\n* Admission diagnosis due to causes other than COPD",{"count":77,"type":21},100000,"This study aims to develop predictive models for patients with a diagnosis of COPD at discharge of an index admission on these outcomes using machine learning:\n\nPrimary outcome: Early admission\n\nSecondary outcomes:\n\n1. Frequent readmission\n2. Composite outcome (Early + Frequent readmissions)\n3. Mortality\n4. Longstayers",[28],"2026-03-17",{"date":82,"type":37},"2026-03-18",{"date":84,"type":37},"2023-08-29",{"date":86,"type":21},"2028-04-30",{"name":88,"class":89},"Chinese University of Hong Kong","OTHER",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100598807","phase-1-a-repeat-ascending-dosing-study-of-the-safety-and-clinical-activity-of-r-3750-in-patients-with-mild-to-moderate-copd-100598807","NCT07076290","A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD","R-3750-01-LU","Inclusion Criteria:\n\n* Subjects with a clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society\u002FEuropean Respiratory Society.\n* Subjects must present with the following: a measured pre and post-salbutamol Forced expiratory volume in one second\u002F Forced vital capacity (FEV1\u002FFVC) ratio of \\\u003C0.70 to confirm the diagnosis of COPD; a measured post-salbutamol FEV1\\>20% and ≤80% of predicted normal values\n* Baseline mMRC dyspnea score 1 to 3\n* Post-bronchodilator FEV1 \\> 50% predicted (GOLD COPD grade 1-2)\n* Smoking pack years ≥ 10 years\n* Age ≥ 40 years\n* Acceptable standard-of-care COPD maintenance therapy includes long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), or combinations thereof (e.g., dual LABA\u002FLAMA, or triple LABA\u002FLAMA\u002FICS therapy). The patient must have been on a stable dose and regimen for at least 4 weeks prior to screening with no changes anticipated during the study unless medically necessary.\n* A history of ≥ 1 exacerbations in the last 12 months\n* Be able to provide written consent; compliant with study procedures and study visits.\n\nExclusion Criteria:\n\n* Patients whose treatment is considered palliative (life expectancy \\\u003C12 months) Comorbid severe lung disease, such as bronchiectasis, pulmonary fibrosis\n* Current smoker or cessation within 3 months of screening, or current use of vaping device\n* Patients with pneumonia or COPD exacerbation or lower respiratory infections within the 4 weeks prior to study Day 1\n* Uncontrolled co-morbid conditions, such as diabetes mellitus, hypertension and heart failure \\[e.g. New York Heart Association (NYHA) class III (e.g. less than ordinary activity causes fatigue, palpitation, or dyspnea), and class IV (e.g. Symptoms of heart failure at rest)\\] that will affect the study.\n* Myocardial infarction, unstable angina or stroke within 12 months prior to screening\n* Diagnosis of malignancy within 5 years of study Day 1(except for excised localized carcinoma of skin not including malignant melanoma)\n* Clinically significant ECG changes, which in the opinion of investigator warrants further investigations\n* Evidence of alcohol, drug or solvent abuse.\n* Pregnant, breastfeeding, or lactating women. Women of child-bearing potential (i.e. not surgically sterilized or post- menopausal) must have a negative blood serum pregnancy test performed at the screening visit and must agree to use two methods of birth control (one of which must be a barrier method) for at least 3 months past the last day on the study.\n* Participation in an interventional clinical study within 3 months of study Day 1 or receipt of any investigational medicinal product within 3 months or 5 half- lives.\n* Lung volume reduction surgery or bronchoscopic lung volume reduction within the last 12 months.\n* Historical or current evidence of clinically significant neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease\u002Fcondition exacerbated during the study.\n* Other conditions that could lead to elevated eosinophils such as Hypereosinophilic syndromes including Eosinophilic Granulomatosis with Polyangiitis, or Eosinophilic Esophagitis.\n* Cirrhosis or current unstable liver disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice. Stable noncirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C -e.g., presence of hepatitis B surface antigen \\[HbsAg\\] or positive hepatitis C antibody test result) is acceptable if the participant otherwise meets entry criteria.\n* Active blood born infection (e.g. HIV, Hepatitis A, B or C)\n* Current or recent (\\\u003C2 weeks) treatment with oral steroids, theophylline, chronic azithromycin or other methylxanthines, roflumilast, or Dupixent\n* Current infection or antibiotic treatment\n* Use of probiotics within 2 weeks of study Day 1\n* Subjects with a current diagnosis of asthma (those with a prior history are eligible if they meet inclusion criteria for a current diagnosis of COPD)\n* Subjects receiving treatment with oxygen more than 4.0 Litres\u002Fminute (L\u002Fmin). While breathing supplemental oxygen, subjects should demonstrate oxyhemoglobin saturation greater than or equal to 89 percent.","82 Years",{"count":99,"type":21},27,[101],"PHASE1","The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate chronic obstructive pulmonary disease (COPD)",[104,28,105],"COPD (Chronic Obstructive Pulmonary Disease)","COPD Exacerbation Acute",[30],"2026-01-27",{"date":109,"type":37},"2026-01-29",{"date":111,"type":21},"2026-09-01",{"date":113,"type":21},"2028-12-31",{"name":115,"class":69},"Rise Therapeutics LLC",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},"100616193","high-intensity-resistance-training-in-post-exacerbation-copd-100616193","NCT07302425","High-intensity Resistance Training in Post-exacerbation COPD","The Effect of the High-intensity Resistance Training in COPD Patients Recovering From Hospital Exacerbation: a Pilot Study","Inclusion Criteria:\n\n* COPD diagnosis according to the GOLD guidelines \\[11\\] with FEV1\u002FFVC \\\u003C70%\n* Stable clinical condition (pH\\>7.30) \\[11\\]\n* Hospital discharge within 3 weeks from an event of hospitalization due to an acute exacerbation of COPD.\n* Absence of significant motor disability, described by the possibility of performing the 6MWT.\n\nExclusion Criteria:\n\n* Presence of lung diseases other than COPD\n* Orthopedic and neurological conditions that prevent the execution of functional tests\n* Severe neurological and cardiologic comorbidities or other severe diseases compromise exercise tolerance.\n* Cognitive impairment evaluated by Mini-Mental State Examination (MMSE) score as \\\u003C 25.","18 Years",{"count":125,"type":21},64,[24],"After a COPD exacerbation, many individuals experience severe weakness in the leg muscles, especially the quadriceps. This weakness can make daily activities difficult and slow down recovery. Traditional respiratory rehabilitation usually focuses on endurance training, which is effective but often hard to tolerate soon after an exacerbation due to persistent symptoms and limited functional capacity.\n\nThis study aims to compare two early rehabilitation approaches during recovery from a COPD exacerbation: a maximal strength training (MST) programme using high loads and few repetitions, and a traditional endurance-based training programme.\n\nThe investigators aim to determine whether MST is easier to tolerate, especially in terms of breathlessness, and whether MST can improve muscle strength, efficiency, and overall exercise tolerance as well as or better than endurance training.\n\nThe results will help identify the most suitable rehabilitation strategy for individuals recovering from a COPD exacerbation, particularly for those who struggle with high-intensity endurance exercise.",[28],[30,130,131,132],"Exacerbation","Early Rehabilitation","High-intensity exercise","2025-12-10",{"date":135,"type":37},"2025-12-24",{"date":137,"type":37},"2025-10-30",{"date":139,"type":21},"2028-05",{"name":141,"class":89},"Istituti Clinici Scientifici Maugeri SpA",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100502963","duet-versus-standard-interface-for-hypercapnic-copd-patients-100502963","NCT05829083","DUET Versus Standard Interface for Hypercapnic COPD Patients","Asymmetric (DUET) Versus Conventional Nasal High Flow Interface for Management of Hypercapnic Patients With Mild to Moderate Acute Exacerbation of COPD: A Randomized, Crossover Clinical Trial","Inclusion Criteria:\n\n* acute exacerbation of COPD (defined as any worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to change in medication)\n* mild-to-moderate acute hypercapnic respiratory failure (defined as 7.35\\>pH\\>7.25 and arterial CO2 tension (PaCO2) \\>45 mmHg)\n\nExclusion Criteria:\n\n* acute on chronic hypercapnic respiratory failure\n* severe facial deformity, facial burns, fixed upper airway obstruction\n* indication for imminent intubation and invasive mechanical ventilation (i.e. respiratory or cardiac arrest, diminished consciousness (Glasgow coma score \\\u003C8)\n* psychomotor agitation inadequately controlled by sedation\n* massive aspiration\n* persistent inability to remove respiratory secretions\n* severe haemodynamic instability unresponsive to fluids and vasoactive drugs\n* severe ventricular or supraventricular arrhythmias\n* life threatening hypoxaemia",{"count":150,"type":21},50,[24],"The goal of this clinical trial is to compare the new asymmetric nasal high flow interface with the conventional high flow nasal cannula in patients with COPD exacerbation.\n\nThe main questions the study aims to answer are:\n\n• Does the use of the asymmetric interface lead to:\n\n1. A greater decrease in the patients' carbon dioxide\n2. A greater decrease in respiratory rate and less dyspnea\n3. Less need for advanced oxygen therapy measures\n4. Same tolerance and comfort\n5. Lower heart rate and blood pressure\n\nParticipants will be asked to:\n\nWear the asymmetric and conventional cannulas for 3 hours each with a 30 minute gap in-between. Arterial blood samples and various clinical parameters will be collected throughout the study period.\n\nResearchers will compare the effect of asymmetric versus conventional cannulas to answer the aforementioned questions.",[28,154,30],"Hypercapnia","2025-09-03",{"date":157,"type":37},"2025-09-10",{"date":159,"type":37},"2023-07-18",{"date":161,"type":21},"2025-12-01",{"name":163,"class":89},"Larissa University Hospital",2,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":45},"100372999","influence-of-freeo2-on-percentage-of-time-within-oxygen-saturation-target-using-noninvasive-ventilation-niv-and-continuous-positive-airway-pressure-cpap-for-patients-admitted-for-aecopd-or-bariatric-surgery-100372999","NCT04136717","Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery","Influence of Automatic Oxygen Titration Device (FreeO2) on Percentage of Time Within Oxygen Saturation Target and Induced Hypercapnia During Noninvasive Ventilation for Patients Hospitalized for an Acute Exacerbation of COPD or a Bariatric Surgery","Inclusion Criteria (AECOPD):\n\n* Respiratory acidosis (pH \\\u003C= 7.35 and PaCO2 \\> 45 mmHg), with or without NIV (last blood gas available during hospitalization)\n* Oxygen therapy and\u002For SpO2 \\\u003C90% room air (FiO2 \\\u003C= 50% or nasal cannula \\\u003C= 7 L\u002Fmin to maintain SpO2 90%)\n* High flow nasal cannula with flow \\\u003C= 30 L\u002Fmin\n\nInclusion Criteria (Bariatric surgery post-op):\n\n* Patients using CPAP before the surgery (obstructive sleep apnea documented).\n* Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Pregnancy\n* Respiratory distress or other clinical situation requiring continuous NIV or CPAP\n* Glasgow \\\u003C 12 or agitation\u002Fdelirium\u002Fdementia (limiting NIV)\n* Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)\n* Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)\n* Refusal to consent to the study\n\n  5 patient with AECOPD and 5 patient with bariatric surgery will be included.",{"count":173,"type":21},10,[24],"The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients.\n\nThe main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.",[28,177,178,179],"Oxygen Toxicity","Abdominal Obesity","Surgery","2025-08-27",{"date":182,"type":37},"2025-09-04",{"date":184,"type":37},"2019-10-28",{"date":186,"type":21},"2028-06",{"name":188,"class":89},"François Lellouche",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":45},"100493343","phase-4-standard-vs-targeted-oxygen-therapy-prehospital-for-chronic-obstructive-pulmonary-disease-100493343","NCT05703919","Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease","STOP-COPD","Inclusion Criteria:\n\n* Patients over the age of 40\n* EMT or Paramedic suspected AECOPD\n* Confirmed suspicion of COPD\n\nExclusion Criteria:\n\n* Bronchospasm due to asthma, allergic reaction or non-COPD conditions\n* Known or suspected pregnancy\n* Prehospital Non-invasive, invasive or assisted bag mask ventilation\n* Allergy to inhaled bronchodilators (Salbutamol)\n* Inter-hospital transfer\n* More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS (emergency medical service) personnel, before allocated treatment is initiated\n* Suspicion of acute coronary syndrome",{"count":197,"type":21},1888,[199],"PHASE4","The STOP-COPD trial is a randomized, patient-blinded, prehospital clinical trial designed to evaluate the effect of titrated oxygen therapy compared to standard oxygen treatment in patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The primary objective is to determine whether a titrated oxygen strategy targeting SpO₂ 88-92% can reduce 30-day mortality compared to the current standard practice using 100% compressed oxygen as a nebulizer driver.",[28,105],[203,28,204,30],"Titrated Oxygen","Prehospital","2025-06-08",{"date":207,"type":37},"2025-06-10",{"date":209,"type":37},"2025-06-02",{"date":211,"type":21},"2028-05-31",{"name":213,"class":89},"Central Denmark Region",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":220,"maxAge":18,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100545256","the-copd-care-study-evaluating-the-impact-of-a-virtual-first-copd-service-on-major-cardiac-and-respiratory-events-100545256","NCT06379529","The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events","Inclusion Criteria:\n\n* Twelve months of claims data in the health insurer or provider's database for baseline\n* ICD10 code for COPD (including emphysema and chronic bronchitis) with a severe exacerbation of COPD in the previous 12 months (defined as ER visit or hospitalization related to COPD or severity score of 2 or 3)\n* Cooperative, i.e., subject should be able to follow and understand instructions\n* Access to a phone (smartphone, cell phone, or landline)\n* Willingness to sign a medical release form for treating healthcare facilities\n\nExclusion Criteria:\n\n* Does not have access to a a phone (smartphone, cell phone, or landline)\n* Lack of cooperation, subject cannot follow and understand instructions\n* Other serious medical illness that, in the opinion of the PI, would interfere with the patient's participation in the study or interpretation of their data (i.e., terminal illness, unstable psychiatric condition, etc.)\n* Does not understand English","30 Years",{"count":222,"type":21},1050,[24],"A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only.",[28,30,226],"Cardio\u002FPulm: Heart Failure",[30,28,228,229,230,231,232],"COPD Hospitalization","COPD Readmission","COPD Costs","Medicare","Medicare Advantage","2025-05-23",{"date":235,"type":37},"2025-05-28",{"date":237,"type":21},"2026-01-01",{"date":239,"type":21},"2027-12-01",{"name":241,"class":69},"NuvoAir Medical PC",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":45},"100496016","effect-of-home-based-pulmonary-rehabilitation-on-exacerbation-and-hospital-admission-in-severe-copd-100496016","NCT05738720","Effect of Home Based Pulmonary Rehabilitation on Exacerbation and Hospital Admission in Severe COPD","The Effect of Close Follow-Up Home Based Pulmonary Rehabilitation on Exacerbation Frequency and Hospital Admission in Severe COPD Cases","Inclusion Criteria:\n\nBeing between the ages of 18-75\n\n* Having a diagnosis of COPD stages C and D diagnosed according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) clinical diagnostic criteria\n* Presence of dyspnea on exertion\n* Stable clinical condition at the time of inclusion without infection or exacerbation in the previous 4 weeks\n* Having the ability to use a smart phone and spirometer after training\n\nExclusion Criteria:\n\n* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\\\min).\n* A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.\n* Participation in a pulmonary rehabilitation program within the past 12 months.","75 Years",{"count":251,"type":21},24,[24],"The study is a randomized controlled trial. The cases will be divided into two groups as the Homespirometer group and the control group. Breathing exercises, aerobic exercise and peripheral muscle strengthening will be performed in both groups. A home-type spirometer will be given to the homespirometer group and it will be requested to send the spirometric measurement every week. The cases will be called to the hospital for control and evaluated at baseline, 3rd, 6th and 12th months. Evaluations include assessments such as exercise capacity measurement, muscle strength measurement, disease attack frequency, symptom scoring.",[28],[256,257,258,259],"copd exacerbation","pulmonary rehabilitation","spirometry","hospital admission","2025-04-29",{"date":262,"type":37},"2025-05-01",{"date":264,"type":37},"2023-02-01",{"date":266,"type":21},"2026-12-20",{"name":268,"class":89},"Saglik Bilimleri Universitesi",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":284,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":297},"100512908","impact-of-continuous-positive-airway-pressure-on-the-occurrence-of-acute-exacerbations-of-copd-in-patients-with-copd-osa-overlap-syndrome-co-os-100512908","NCT05958563","Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)","Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS) SLEEPOVEA","SLEEPOVEA","Inclusion Criteria:\n\n* 40 years of age or older\n* Grade of 2 or higher on the modified Medical Research Council scale (which ranges from 0 to 4, with higher grades indicating more severe dyspnea)\n* A post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 70% of the predicted value, and a postbronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70.\n* Documented history of at least one moderate or severe COPD exacerbation during the previous year\n* Clinical suspicion of OSA (based on a STOP-bang questionnaire \\>3),\n* Have a telephone or a tablet or accept to use one during the study,\n* Willing and able to comply with all study procedures,\n* Subjects covered by or having the rights to medical care assurance.\n* An apnea-hypopnea index \\[AHI\\], ≥15 per hour based on a full night polysomnography and no significant central apneas (\\\u003C5 central apneas per hour of sleep\n\nExclusion Criteria:\n\n* Severe daytime sleepiness (Epworth sleepiness Scale \\>14\u002F24 and\u002For frequent sleepiness while driving or patient escaping a sleep-onset accident within the last 12 months),\n* Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke),\n* Patient on long-term oxygen therapy or non-invasive ventilation\n* Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg)\n* Previously diagnosed and treated OSA\n* Any rehabilitation program or any lung volume reduction procedure planned in the oncoming year\n* Pregnancy, breastfeeding\n* Bad understanding of the French language,\n* Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act",{"count":278,"type":21},500,[24],"Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends \"randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated\".",[282,28,283],"Sleep Apnea","Overlap Syndrome",[285,286,287],"sleep apnea","copd","overlap syndrome","2025-04-09",{"date":290,"type":37},"2025-04-13",{"date":292,"type":37},"2024-01-09",{"date":294,"type":21},"2028-01-01",{"name":296,"class":44},"University Hospital, Angers",15,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":306,"targetDuration":308,"studyType":56,"phases":4,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":45},"100485277","non-contact-proactive-remote-monitoring-of-copd-exacerbations-100485277","NCT05598983","Non-contact Proactive Remote Monitoring of COPD Exacerbations","Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)","DetectEx","Inclusion Criteria:\n\n1. Confirmed diagnosis of COPD\n2. 1 or more exacerbation in the last year\n3. Aged over 18 years\n4. Willing to use monitoring devices and complete study questionnaires\n5. Adequate English\n6. Signed consent form\n\nExclusion Criteria:\n\n1. Pregnancy\n2. BMI greater than 45 kg\u002Fm2\n3. Nil other, provided inclusion criteria are met.",{"count":307,"type":21},75,"12 Months","The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are:\n\n* Can an exacerbation be detected before the person recognizes they are unwell?\n* What are the biological signals which provide the best indication of decompensation?\n* How does this indication of decompensation compare to a daily CAT?\n\nParticipants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.",[28],"2025-03-19",{"date":313,"type":37},"2025-03-24",{"date":315,"type":37},"2023-05-15",{"date":317,"type":21},"2026-05-15",{"name":319,"class":69},"Life Detection Technologies",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100542797","phase-3-supported-rescue-packs-post-discharge-in-chronic-obstructive-pulmonary-disease-100542797","NCT06347536","Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease","Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease: An Open-label Multicenter Randomised Controlled Trial","RAPID","Inclusion Criteria:\n\n* Age ≥ 40 years\n* Individuals admitted to hospital with COPD exacerbation who have recently been discharged (discharged from ongoing support from secondary care team which includes hospital and virtual wards). Admission is defined as an episode in which a patient with an exacerbation of COPD is admitted to a ward and has stayed in hospital for 4 hours or more, including Emergency Medicine Centres, Medical Admission Units, Clinical Decision Units, short stay wards or similar but excludes patients treated transiently before being discharged from Emergency Department.\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Individuals who require invasive ventilation during the hospital admission\n* Patients who have an expected survival of less than 90 days\n* Patients with signs of new consolidation on chest X-ray (if available).\n* Individuals who have been discharged to a residential or nursing home to residential or nursing home.\n* Individuals who are unable to manage a supported self-management plan.\n* Individuals with no access to telephone.\n* Individuals who are already taking part in an interventional trial.\n* Previous participation in the RAPID trial.",{"count":329,"type":21},1400,[331],"PHASE3","Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.\n\nSevere exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.\n\nA multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone\u002Ftext symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.",[30,28],[30,335,259,336,337],"exacerbation","rescue packs","self-management support","2025-02-06",{"date":340,"type":37},"2025-02-10",{"date":342,"type":37},"2025-01-30",{"date":344,"type":21},"2027-12-31",{"name":346,"class":89},"Guy's and St Thomas' NHS Foundation Trust",34,{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100329054","nasal-high-flow-in-copd-100329054","NCT03564236","Nasal High-Flow in COPD","Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?","High-TeC","Inclusion Criteria:\n\nPatients have to fulfil all of the following inclusion criteria:\n\n* History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\\\u003C 80% of predicted with an FEV1\u002Fforced vital capacity (FVC) ratio \\\u003C70), with a history of at least 10 pack years smoking.\n* Being admitted to the hospital with a COPD exacerbation\n* Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and\u002For hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \\> 7.34\n* At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and\u002For antibiotics and\u002For hospital admission)\n* Written informed consent is obtained\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* No lung function data available\n* The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission\n* Inability to comply with the tests\n* The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).",{"count":357,"type":21},136,[24],"Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations.\n\nNasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown.\n\nObjective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT.\n\nStudy design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the \"Medisch Spectrum Twente\", \"Albert Schweizer ziekenhuis\", Rijnstate hospital, and the University of Twente, collaborating.\n\nStudy population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included.\n\nIntervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours\u002Fday) during hospitalisation and the 90 days after discharge, as added to standard care.\n\nMain study parameters\u002Fendpoints: The primary outcome will be improvement in HRQoL after 90 days.",[28],"2024-12-04",{"date":363,"type":37},"2024-12-05",{"date":365,"type":37},"2018-10-01",{"date":367,"type":21},"2025-12-30",{"name":369,"class":89},"Marieke Duiverman",3,{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":45},"100569219","role-of-oral-care-in-prevention-of-nosocomial-pneumonia-among-copd-patients-100569219","NCT06691399","Role of Oral Care in Prevention of Nosocomial Pneumonia Among COPD Patients","Routine Oral Care Versus Chlorhexidine Oral Care on Incidence of Nosocomial Pneumonia and Oral Health Among Critically Ill Non-intubated Patients With COPD","Inclusion Criteria:\n\n* Patients diagnosed as COPD\n* admitted to ICU with acute exacerbation\n* need for noninvasive ventilatory support including noninvasive ventilation anf high flow nasal cannula\n\nExclusion Criteria:\n\n* patients refusing to participate\n* End stage organ failure (Heart Failure, Liver cell failure and\u002For Renal failure",{"count":379,"type":21},60,[24],"Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.",[383,28],"Nosocomial Pneumonia",[30,385,386,387],"Oral care","Nosocomial pneumonia","Chlorhexidine","2024-11-14",{"date":390,"type":37},"2024-11-15",{"date":392,"type":37},"2024-10-01",{"date":394,"type":21},"2025-06-01",{"name":396,"class":89},"Assiut University",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":406,"conditions":407,"keywords":418,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":45},"100566342","study-of-sleep-quality-in-the-intensive-care-unit-and-association-with-weaning-from-invasive-ventilation-in-patients-with-chronic-obstructive-bronchopneumopathy-100566342","NCT06653933","Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.","SLEECOP","Inclusion Criteria:\n\n* Patients diagnosed with COPD according to the GOLD criteria.\n* Mechanical ventilation by endotracheal tube and mechanical ventilation for \\&gt; 24 hours.\n* Withdrawal of treatment with continuous sedation and\u002For neuroleptics.\n* Adequate recovery with Glasgow Coma Scale ≥ 8.\n\nExclusion Criteria:\n\n* Patients with central nervous system damage or neuromuscular pathology.\n* Pregnant or postpartum patients.\n* Patients or their relatives who object to participating in the study.",{"count":405,"type":21},42,"Patients admitted in ICU may require invasive mechanical ventilation, using a mechanical ventilator and an endotracheal tube.\n\nIn ICU, a prolonged duration of invasive mechanical ventilation may be responsible for ventilator-induced lung injury, pulmonary infection, prolonged administration of sedation, neuromyopathy and prolonged length of stay. The goal of the ICU healthcare teams is therefore to reduce the duration of invasive mechanical ventilation as much as possible.\n\nICU patients have many sleep disturbances: sleep fragmentation, sleep stage changes, changes in sleep architecture. These sleep disturbances are due to sedation and analgesia, delirium, patient care activities, noise and altered day-night cycles.\n\nChronic obstructive pulmonary disease (COPD) is a common respiratory disease. COPD complicates the management of invasive mechanical ventilation, particularly weaning of this invasive mechanical ventilation and extubation (removal of the intubation tube).\n\nTo reduce the risk of reintubation, it is recommended that a weaning test is performed prior to extubation. The purpose of this test is to simulate the conditions of breathing without the help of a ventilator after extubation. If the weaning test is successful, the patient can theoretically be extubated.\n\nThere are several causes associated with extubation failure, but studies suggest that sleep deprivation or poor sleep quality in the nights before extubation is one of them. In addition, patients with COPD often have chronic sleep disturbances or induced by their stay in the ICU (asthenia, bed rest, anxiety, sedation, etc.).\n\nThe aim of our study will be to compare the sleep characteristics of COPD patients with a failed weaning test and those with a successful test. Our hypothesis is that patients with a failed weaning test will have more sleep disturbances in the period of 72 hours before the weaning test.",[30,28,408,409,410,411,412,413,414,415,416,417],"Ventilated Patients","Ventilator-Associated Pneumonia (VAP)","Ventilator Weaning","Weaning of Mechanical Ventilation","Sleep Quality","Sleep Disorders, Circadian Rhythm","Sleep Disorders","Failure, Respiratory","ICU Hospitalization","ICU Sedation",[30,412,411],"2024-10-21",{"date":421,"type":37},"2024-10-23",{"date":423,"type":21},"2025-01-01",{"date":425,"type":21},"2027-07-01",{"name":427,"class":89},"University Hospital, Grenoble",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":164},"100478228","phase-2-effects-of-blocking-tslp-on-airway-inflammation-and-the-epithelial-immune-response-to-exacerbation-triggers-in-patients-with-copd-100478228","NCT05507242","Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD","Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD","UPSTREAM-COPD","Inclusion Criteria:\n\n* Written informed consent\n* A diagnosis of COPD (according to GOLD (GOLD 2021 Report))\n* ≥ 10 packyears smoked (current or ex-smokers)\n* Age 40 years or older\n* Postbronchodilator FEV1 ≥ 30% predicted (and ≥ 1.0L) and \\\u003C 80% predicted\n* Maintenance treatment with LAMA+LABA±ICS (stable dose) for at least 3 months prior to V1\n* ≥1 prednisolon and\u002For antibiotic treated exacerbation in the past 12 months\n* Subjects must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff)\n* Subjects must demonstrate ≥ 70% compliance with daily inhalers during the screening\u002Frun-in\n* Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions through Week 20 of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n\nExclusion Criteria:\n\n* Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.\n* Any concomitant respiratory disease that in the opinion of the investigator will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis, pulmonary fibrosis, aspergillosis, active tuberculosis).\n* Current asthma\n* Lung volume reduction surgery for COPD\n* Exacerbation requiring oral corticosteroids or antibiotics (any dose for more than 3 days) 4 weeks prior to Visit 1 or during the run-in period\n* Any use of home oxygen therapy\n* Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his\u002Fher participation in the study, or may influence the results of the study, or the subject's ability to participate in the study\n* History of cancer: Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1. Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.\n* Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 4 weeks prior to Visit 1 or during the screening period\n* A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history\n* Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.\n* History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.\n* History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency.\n* Active tuberculosis or history of untreated latent tuberculosis\n* History of anaphylaxis to any biologic therapy.\n* Use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1.\n* Receipt of any of the following within 30 days prior to Visit 1: immunoglobulin or blood products, or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior Visit 1, whichever is longer.\n* Receipt of any marketed or investigational biologic agent within 4 months or 5 half- lives prior to Visit 1, whichever is longer.\n* Pregnant, breastfeeding or lactating females\n* History of chronic alcohol or drug abuse within 12 months prior to Visit 1.\n* Planned surgical procedures requiring general anesthesia or in-patient status for \\> 1 day during the conduct of the study.\n* Unwillingness or inability to follow the procedures outlined in the protocol.\n* Concurrent enrollment in another clinical study involving an investigational treatment.\n* Receipt of any live or attenuated vaccines within 15 days prior to Visit 1.",{"count":437,"type":21},80,[439],"PHASE2","A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.",[30,28,442,443,444],"COPD Bronchitis","Airway Disease","Immune System Disorder",[30],"2024-08-19",{"date":448,"type":37},"2024-08-21",{"date":450,"type":37},"2022-10-25",{"date":452,"type":21},"2025-12-31",{"name":454,"class":89},"Asger Sverrild",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":45},"100539466","telehealth-and-onsite-maintenance-exercise-in-chronic-lung-disease-100539466","NCT06304207","Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease","Comparison of Telehealth and Onsite Supervised Maintenance Exercise Program for Adults With Chronic Lung Disease: A Pilot Randomized Controlled Trial","CLD","Inclusion Criteria:\n\n* All adult patients 40 years and older with physician diagnosed Chronic Lung Disease within 2 months of discharge following completion of a traditional onsite outpatient rehabilitation or physical therapy or exercise program for their condition\n* Able to walk independently with or without mobility devices\n* Able to complete a six-minute walk test at discharge with or without supplemental oxygen maintaining an oxygen saturation at or above 85%\n* Able to follow commands and instructions in the English language\n* Have ability to connect to the internet\n\nExclusion Criteria:\n\n* • Those with significant mobility limitations such as those with a history of stroke, neurological comorbidities such as Parkinson's disease or relapsing multiple sclerosis, or significant degenerative osteoarthritis, or any other joint impairments that compromise ability to walk independently with or without an assistive device.\n\n  * Patients who primarily rely on a wheelchair for mobility\n  * Patients with or without supplemental oxygen who are unable to complete a walking test without a drop in oxygen saturation to below 85% at discharge from traditional outpatient rehabilitation\n  * Patients with baseline hemodynamic compromise, unstable angina, a recent myocardial infarction within a week, uncontrollable atrial fibrillation not managed with medications, advanced stage heart failure (New York Heart Association class 4), or those with mechanical circulatory assist devices for the heart such a ventricular assist device (VADs)\n  * Inability to communicate in the English language",{"count":55,"type":21},[24],"The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease.\n\nThe specific aims of the study are:\n\n* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.\n* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation.\n\nParticipants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.",[27,28,442,467,468,469,470,471,472,473],"Emphysema or COPD","Chronic Lung Disease","Pulmonary Fibrosis","Interstitial Lung Disease","Bronchiectasis","Chronic Asthma","Chronic Asthmatic Bronchitis","2024-07-30",{"date":476,"type":37},"2024-08-01",{"date":478,"type":37},"2023-09-01",{"date":480,"type":21},"2026-03-01",{"name":482,"class":89},"MGH Institute of Health Professions",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":45},"100354078","respiratory-support-in-chronic-obstructive-pulmonary-disease-copd-patients-100354078","NCT03890224","Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients","Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support","Inclusion Criteria:\n\n* 1\\) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)\\\u003C65%;\n* 2\\) AHRF (pH\\\u003C7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive);\n* 3\\) 48h to 2 weeks with pH\\>7.35, and PaCO2\\>45 (\\>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%).\n\nExclusion Criteria:\n\n1. Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment;\n2. Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the \"FEV1\u002FForced vital capacity (FVC)\" ratio is \\\u003C60% and the FEV1 \\\u003C50% if the predominant defect is considered to be obstructive by the center clinician;\n3. BMI \\> 35 kg\u002Fm2;\n4. Sedative medication causing hypercapnia (\\> 3 drugs or more than 20mg of morphine\u002Fday);\n5. Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI\\>30\u002Fh (French criteria);\n6. Cognitive impairment that would prevent informed consent into the trial\n7. Pregnancy;\n8. Tobacco use \\\u003C 10 pack-year;\n9. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge;\n10. Unstable coronary artery syndrome;\n11. Age \\\u003C18 years;\n12. Inability to comply with the protocol;\n13. Expected survival\\\u003C12 months due to any situation other than COPD disease;\n14. Duration of ICU stay\\>10 days;\n15. No affiliated to national health insurance;\n16. Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.",{"count":491,"type":21},400,[24],"The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.",[495,28],"Chronic Obstructive Pulmonary Disease",[497],"Respiratory Support","2024-06-17",{"date":500,"type":37},"2024-06-20",{"date":502,"type":37},"2019-07-04",{"date":504,"type":21},"2027-02-28",{"name":506,"class":89},"Clinact",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":123,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":45},"100316177","freedom-innovative-strategy-for-the-management-of-copd-exacerbations-100316177","NCT03396172","FreeDom: Innovative Strategy for the Management of COPD Exacerbations","FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation","Inclusion Criteria:\n\nAll patients hospitalized for COPD exacerbation for less than 48 hours will be considered.\n\n* known or suspected COPD to entry\n* Age \\> or = 40 years\n* Ex-smoker history (10 pack \u002F year or more)\n* Acute Exacerbation: dyspnea of recent onset (less than 15 days)\n* The need for oxygen therapy with a moderate rate: \\\u003C6L \u002F min to maintain SpO2 \\> 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)\n\nExclusion Criteria:\n\n* Refusal to consent to participate in the study,\n* Indication for an imminent intubation according to the pulmonologist,\n* Sleep Apnea\n* NIV used at home\n* Lack of FreeO2 system available at the time of randomization\n* Non-autonomous and alone at home\n* Patient alone at home\n* Patients who live more than 50 km from the hospital\n* Patient already included in the study within 3 months",{"count":515,"type":21},100,[24],"The main objective of the study is to assess the \"FreeDom\" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.\n\nThe main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.",[519,28],"Oxygen Deficiency",[30,521,522,523,524,525],"Homecare","Oxygen","Telemedicine","Automated oxygen adjustment","Rehabilitation program",{"date":527,"type":37},"2024-06-18",{"date":529,"type":37},"2018-05-24",{"date":531,"type":21},"2025-12",{"name":533,"class":89},"Laval University",{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":542,"targetDuration":544,"studyType":56,"phases":4,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":164},"100535861","patients-with-severe-acute-exacerbation-of-copd-ans-admitted-in-icu-register-100535861","NCT06257329","Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register.","Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of Prognosis and Factors Associated With Survival.","COPDregister","Inclusion Criteria:\n\n1. Age ≥ 40 years old\n2. COPD documented or strongly suspected\n\n   * Chronic respiratory symptoms (dyspnoea, cough and\u002For sputum)\n   * Exposure to a known risk factor for COPD (such as tobacco smoke)\n   * If available, respiratory function tests showing non- or partially reversible obstructive syndrom (post-bronchodilator ratio FEV1\u002FCV \\\u003C 0.7)\n3. Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and\u002For hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)\n4. Admission to an ICU, a step-up unit or a respiratory care unit\n\nExclusion Criteria:\n\n1. Known asthma (according to the criteria of the international \"Global initiative for asthma\" guidelines)\n2. Patient refusal to participate (information note, application for non-opposition)",{"count":543,"type":21},2000,"5 Years","The objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of admitted patients in ICU for severe acute exacerbation of COPD, to assess the different therapeutics used, to evaluate the prognosis of patients with short, medium and long term ( 1 year) and the various factors associated with survival in ICU",[28],"2024-02-06",{"date":549,"type":37},"2024-02-13",{"date":551,"type":37},"2022-10-01",{"date":553,"type":21},"2028-04-01",{"name":555,"class":89},"Alexis FERRE"]