[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-exacerbation-of-copd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-exacerbation-of-copd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,70,98,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100584547","remote-monitoring-of-copd-patients-experiencing-an-acute-exacerbation-through-health-evaluations-using-wearable-mobile-technology-100584547",false,"NCT06890767","Remote Monitoring of COPD Patients Experiencing an Acute Exacerbation Through Health Evaluations Using Wearable Mobile Technology","COPD-BREATHE","Inclusion Criteria:\n\n* Provide signed and dated informed consent\n* Adults older than 18 years of age\n* Previously diagnosed with COPD\n* Speak and understand the Dutch language\n* Need for hospitalization\n\nExclusion Criteria:\n\n* Previous diagnosis of asthma\n* Not in the possession of a smartphone","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","Chronic obstructive pulmonary disease (COPD) causes about 3 million deaths annually and significantly burdens healthcare systems, costing the EU 38.6 billion euros, largely due to frequent hospitalizations triggered by acute exacerbations (AECOPD). AECOPD worsens patient health, accelerates lung decline, and lowers quality of life, highlighting the need for early detection. Moreover, these AECOPD events happen in an out-hospital setting and are therefore, not preventable. A clear clinical and quality-of-life need arises to reduce AECOPD-related events and consequent hospitalizations.\n\nMobile health (mHealth) offers a solution by monitoring patients remotely using unobtrusive wearable devices. Parameters like peripheral oxygen saturation (SpO2) and respiratory rate can detect and predict exacerbations. However, no data at home is available of AECOPD events and robust predictive algorithms are lacking. This study aims to monitor vital parameters at home, tracking physical activity, pulse, respiratory rate, SpO2, sleep, and skin temperature from the moment of ER admission until three months post-discharge. Data will be used to gain insight in the COPD progression following an AECOPD event and to construct a predictive model, enabling timely intervention, reducing hospitalizations, and improving outcomes.",[26,27],"Chronic Obstructive Pulmonary Disease (COPD)","Acute Exacerbation of COPD",[29,30,31,32],"Mobile Health","COPD","Remote Monitoring","AECOPD","RECRUITING","2026-03-03",{"date":36,"type":37},"2026-03-04","ACTUAL",{"date":39,"type":37},"2025-03-01",{"date":41,"type":20},"2026-03-01",{"name":43,"class":44},"David Ruttens","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100522553","high-flow-nasal-oxygen-for-exacerbation-copd-100522553","NCT06084117","High Flow Nasal Oxygen for Exacerbation COPD","High Flow Nasal Oxygen For Hypercapnic, Acidotic Exacerbation Chronic Obstructive Pulmonary Disease","HiCAP","Inclusion Criteria:\n\n* Known chronic obstructive pulmonary disease\n* Acute hypercapnic exacerbation of this condition, defined as: PaCO2\\>45 mmHg or \\>6.0 kPa and pH 7.20-7.35\n* Age \\>40 years\n\nExclusion Criteria:\n\n* Asthma\n* Immediate need for intubation, based on clinical judgement of the attending physician.\n* Impossibility to apply either one of the two interventions\n* Patient not expected to give immediate or delayed informed consent (e.g. known cognitive impairment, dementia, active serious psychiatric disease, mental retardation).\n* Established home-NIV or home CPAP, known indication for home-NIV or CPAP (e.g. OSAS or obesitas hypoventilation syndrome).\n* Impeding death\n* Concurrent (respiratory) diseases that may influence treatment efficacy: acute heart infarction, cardiogenic lung edema, massive pulmonary embolism (intermediate-high risk or more). NB; pulmonary infections (viral and bacterial) are a common cause of exacerbation and are no reason for exclusion.\n* Other acute diseases that preclude participation in the trial such as hemodynamic instability (need for vasopressors), reduced consciousness with need for intubation, severe intoxication\n* Tracheostomized patients\n* Participation in other interventional trials\n* Impossibility to admit the patient to the participating ICU or monitored ward (e.g. medium care \u002F high dependency unit, depending on local infrastructure).\n* Previous explicit (or written) objection to participation in research - bicarbonate \\\u003C20 mmol\u002FL","40 Years",{"count":56,"type":20},40,[23],"In this pilot study the feasibility of performing a larger trial to study the non-inferiority of High Flow Nasal Oxygen compared to non-invasive ventilation in patients with acute acidotic hypercapnic exacerbation of COPD wil be investigated",[27],"2025-08-20",{"date":62,"type":37},"2025-08-21",{"date":64,"type":37},"2024-05-14",{"date":66,"type":20},"2026-12-01",{"name":68,"class":44},"Franciscus Gasthuis",4,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100460784","use-of-multiplex-pcr-procalcitonin-and-sputum-appearance-to-reduce-duration-of-antibiotic-therapy-during-severe-copd-exacerbation-a-controlled-randomized-open-label-parallel-group-multicenter-trial-100460784","NCT05280132","Use of MULTIplex PCR, Procalcitonin, and Sputum Appearance to Reduce Duration of Antibiotic Therapy During Severe COPD EXAcerbation: A Controlled, Randomized, Open-label, Parallel-Group, Multicenter Trial","MULTI-EXA","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* COPD (according to GOLD 2020), whatever the stage (I-IV)\n* Acute exacerbation (defined as the onset or worsening of one or more of the usual signs\u002Fsymptoms of COPD) with acute worsening of respiratory symptoms that result in additional therapy) with acute respiratory failure requiring admission to ICU and ventilatory support (invasive mechanical ventilation or non-invasive mechanical ventilation or high-flow nasal oxygen therapy with FiO2 ≥ 50%)\n* Informed consent of patient, patient's immediate family\u002F or inclusion in an emergency situation\n* Affiliation to a social security\n\nExclusion Criteria:\n\n* The interval between admission to the hospital and admission to ICU more than 3 days\n* Antibiotic therapy clearly needed for a suspected or documented extra-respiratory infection\n* Congenital or acquired immunosuppression (congenital immune deficiency, high-grade hematologic malignancies, use of immunosuppressive drugs in the last 30 days including anti-cancer chemotherapy and antirejection medications, corticosteroid treatment ≥ 20 mg\u002Fd prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4 \\\u003C200 \u002F µL in the past 6 months)\n* Tracheotomy\n* Bronchiectasis \u002F cystic fibrosis\n* Moribund patient (imminent death)\n* Patient deprived of liberty and \u002F or under legal protection measure\n* Patient already included in MULTI-EXA\n* Patient already included in a type 1 interventional study on antibiotics\n* Ongoing pregnancy",{"count":78,"type":20},204,[23],"COPD is a common chronic disease. Its natural course is characterized by Acute exacerbations (AE). This may require hospitalization or even ICU\u002FRESUSCITATION admission. The most common causes are respiratory distress with hypercapnic acidosis that requires mechanical ventilation (Invasive or non-invasive). Lower respiratory tract infections, bacteria and\u002For viruses are the main pathogenic factors of AE. The treatment of AECOPD is initially symptomatic treatment, combining bronchodilators, ventilatory support (oxygen therapy and\u002For mechanical ventilation) and respiratory physiotherapy. Systemic corticosteroid therapy is optional. When i) the sputum is purulent and ii) increased dyspnea and \u002F or an increase in sputum volume is observed, antibiotic treatment is recommended for hospitalized patients. Antibiotic therapy is routinely recommended when mechanical ventilation is required.\n\nDuring ICU\u002FRESUSCITATION AECOPD, more than 85% of patients received antibiotic therapy, with a median duration of 8 to 9 days, and the benefit of antibiotic therapy is likely to be limited to infected patients. Suspected or documented lower respiratory tract bacteria, that is, 25% to 50% of patients. This will lead to overuse of antibiotics, which is a problem for patients and the community.\n\nA personalized antibiotic strategy could limit this phenomenon, relying on multimodal methods, using aspect of sputum (clinical method), procalcitonin (PCT) (biological method) and the FilmArray ™ Pneumonia Panel extended panel multiplex respiratory PCR Plus (mPCR FA-PPP) (Biomérieux®) (microbiological approach).\n\nThe hypothesis of this study is that sputum appearance, procalcitonin (PCT) and the FilmArray ™ Pneumonia Panel Plus expanded panel multiplex respiratory PCR (mPCR FA-PPP) (Biomérieux®) could be used in combination , and their results integrated into a decision-making algorithm aimed at personalizing antibiotic therapy and guiding its early termination in patients admitted to ICU\u002FRESUSCITATION due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) to the main benefit of antibiotic savings, and without additional risk to patient safety.",[27],[32,83,84,85,86,87,88],"respiratory multiplex PCR","Appearance of sputum","Procalcitonin","Antibiotics saving","Diagnosis","Treatment","2025-06-24",{"date":91,"type":37},"2025-06-25",{"date":93,"type":37},"2022-12-08",{"date":95,"type":20},"2026-06",{"name":97,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100584349","survey-on-niv-settings-in-the-intensive-care-unit-for-acute-exacerbation-of-copd-100584349","NCT06888180","Survey on NIV Settings in the Intensive Care Unit for Acute Exacerbation of COPD","Survey on Non-Invasive Ventilation Settings in the Intensive Care Unit for Acute Exacerbation of Chronic Obstructive Pulmonary Disease","NIV-ICU","Inclusion Criteria:\n\n* Adult COPD Patient\n* Known or suspected COPD diagnosis as assessed by the attending physicians\n* Admitted to a medical intensive care unit (MICU), respiratory intensive care unit, or MICU\n* Hypercapnic respiratory distress\n* NIV indication determined by the physician\n* Covered by social security\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Other obstructive diseases (asthma, bronchiectasis, cystic fibrosis, bronchiolitis, pulmonary fibrosis, restrictive thoracic syndrome) Central hypoventilation (Ondine's syndrome, iatrogenic), neurological (neuromuscular disease), osteoarticular (kyphoscoliosis), or ENT-related causes\n* Immediate need for intubation\n* Acute pulmonary edema\n* Contraindications to NIV (untreated pneumothorax, shock, cardiac arrest, uncontrolled vomiting, upper gastrointestinal bleeding, cervicofacial trauma, coma except when related to hypercapnia)\n* Patients under legal guardianship\n* Incarcerated individuals",{"count":107,"type":20},976,"OBSERVATIONAL","Introduction Chronic obstructive pulmonary disease (COPD) is a common condition and the fourth leading cause of death worldwide. With the rise of non-invasive ventilation (NIV), mortality among patients admitted for acute hypercapnic respiratory failure has decreased, though to a lesser extent than reported in the studies that validated this technique. We hypothesize that inappropriate initial ventilatory parameter settings for NIV could be associated with increased morbidity and mortality in this context.\n\nObjective The primary objective of this study is to assess the initial NIV settings used in intensive care units (ICUs) and respiratory intensive care or medical intensive care units (MICUs) in this patient population. A secondary objective is to evaluate whether specific ventilatory settings are associated with mortality or the need for invasive mechanical ventilation (IMV).\n\nMethods This is a prospective multicenter observational study aiming to include 976 patients. NIV settings will be recorded at initiation, after the first recommended arterial blood gas (ABG) evaluation (between 1.5 and 2 hours of ventilation), and at 24 and 48 hours. Patient characteristics, including medical history, clinical and biological parameters at admission, will be collected. Vital status and the need for IMV will be recorded at ICU discharge and on day 28 (D28).",[111,27,112],"COPD (Chronic Obstructive Pulmonary Disease)","Hypercapnic Respiratory Failure, COPD",[30,114,115,116],"Acute exacerbation of COPD","Non invasive ventilation","Hypercapnic respiratory failure","NOT_YET_RECRUITING","2025-03-24",{"date":120,"type":37},"2025-03-26",{"date":122,"type":20},"2025-09",{"date":124,"type":20},"2027-09",{"name":126,"class":44},"University Hospital, Caen",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":45},"100461306","antibiotic-stewardship-in-aecopd-through-crp-guided-management-100461306","NCT05286918","Antibiotic Stewardship in AECOPD Through CRP-Guided Management","Antibiotic Stewardship Through CRP-guided Antibiotic Treatment for Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)","Inclusion Criteria:\n\n1. Being diagnosed with active AECOPD (AECOPD is defined as an event in the natural course of a disease characterized by a change in baseline dyspnoea, cough, and\u002For sputum that is beyond the normal day-to-day variations with acute onset, which may warrant a change in regular medication in patients with underlying COPD).\n2. Known COPD in their medical records.\n3. Age 40 years or older.\n4. Able to provide informed consent in Cantonese, Mandarin, or English\n5. Able to complete the questionnaires during the study period (i.e. 6 months after randomisation)\n\nExclusion Criteria:\n\nPatients will be excluded if any ONE of the following are present:\n\n1. Pre-treatment with systemic corticosteroids for the present exacerbation.\n2. Pre-treatment with any antibiotics for the present exacerbation, any concurrent infection or prophylaxis.\n3. Known clinical stroke in past 6 months\n4. Patients with high suspicion of active AECOPD mimics:\n\n   1. Pneumonia\n   2. Congestive heart failure\n   3. Bronchiectasis\n   4. Pulmonary embolism\n   5. Pneumothorax\n   6. Atrial fibrillation \u002F flutter\n5. Lung comorbidities:\n\n   1. Cystic fibrosis\n   2. Tuberculosis\n   3. Unresolved lung malignancy\n6. Progression or new radiographic abnormalities on the chest X-ray.\n7. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs for more than 28 days.\n8. Active inflammatory condition (e.g. flare up of rheumatoid arthritis, gout or polymyalgia rheumatica) or concurrent infection at another site (e.g. UTI, cellulitis) that is likely to produce a systemic response\n9. Currently pregnant\n10. NEWS2 score of ≥3",{"count":135,"type":20},1184,[23],"Objectives:\n\nTo determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD health status with usual care.\n\nHypothesis to be tested:\n\n(i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups.\n\nDesign and subjects:\n\nMulti-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A\\&E.\n\nInstruments:\n\nClinical COPD Questionnaire and EuroQol-5D\n\nInterventions:\n\nBoth intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP \\>5mg\u002FdL. Once CRP has declined to \\\u003C5mg\u002FdL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered.\n\nCommunication with Receiving Ward Staffs:\n\nParticipants in the study may transfer to another departments after treatment\u002F care in A\\&E. The following communication would be conducted:\n\n* A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A\\&E. The note would also suggest the investigations for the receiving ward staffs.\n* Telephone handover about intervention group and investigations of the study, and treatments given in A\\&E to ward.\n\nMain outcome measures:\n\nThe antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation.\n\nData analysis:\n\nIntention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation.\n\nExpected results:\n\nThe intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.",[27,139,140,141,142],"Lung Diseases","Lung Diseases, Obstructive","Pulmonary Disease, Chronic Obstructive","Respiratory Tract Disease",[30,144,145,146,147],"Antibiotics","C-Reactive Protein","Antibiotic stewardship","Emergency Department","2022-05-16",{"date":150,"type":37},"2022-05-23",{"date":152,"type":20},"2022-09-01",{"date":154,"type":20},"2026-08-31",{"name":156,"class":44},"The University of Hong Kong"]