[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"copd-exacerbation-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:copd-exacerbation-acute":190},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,74,99,122,148,169],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100440187","evaluation-of-high-dose-prednisolone-pharmacokinetics-in-the-acute-and-chronic-setting-100440187",false,"NCT05012033","Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting","EHD-Pred PK","Inclusion Criteria:\n\n* Aged 18 - 75 years\n* Male or female\n* Participants who are otherwise healthy enough to participate, as determined by pre-study medical history\n* Participants who are able and willing to give written informed consent to participate in the study\n* Group A only: Patients requiring acute (\\\u003C5 days) high dose (minimum 30mg) oral prednisolone therapy for antiinflammatory purposes in either an inpatient or outpatient setting.\n* Group B only: Minimum of 1 month duration of high dose prednisolone (\\>30mg) if in the chronic use group.\n* Group C only: Patients started on high dose methylprednisolone (\\>3 day course) or prolonged courses of dexamethasone.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.\n* Unable to give informed consent.\n* Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).\n* Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.\n* Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.\n* History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.","ALL","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","This is a pilot study to investigate serum prednisolone profiles in:\n\n* Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting.\n* Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone.\n\nThe study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone.\n\nThe study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.",[25,26,27,28,29],"Thyroid Eye Disease","Vasculitis","COPD Exacerbation Acute","Asthma","Inflammatory Disease","RECRUITING","2026-03-24",{"date":33,"type":34},"2026-03-27","ACTUAL",{"date":36,"type":34},"2023-04-12",{"date":38,"type":21},"2030-12-31",{"name":40,"class":41},"Imperial College London","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"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.","40 Years","82 Years",{"count":53,"type":21},27,"INTERVENTIONAL",[56],"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)",[59,60,27],"COPD (Chronic Obstructive Pulmonary Disease)","COPD Exacerbation",[62],"COPD","NOT_YET_RECRUITING","2026-01-27",{"date":66,"type":34},"2026-01-29",{"date":68,"type":21},"2026-09-01",{"date":70,"type":21},"2028-12-31",{"name":72,"class":73},"Rise Therapeutics LLC","INDUSTRY",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":54,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":42},"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":82,"type":21},1888,[84],"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.",[60,27],[88,60,89,62],"Titrated Oxygen","Prehospital","2025-06-08",{"date":92,"type":34},"2025-06-10",{"date":94,"type":34},"2025-06-02",{"date":96,"type":21},"2028-05-31",{"name":98,"class":41},"Central Denmark Region",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":54,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},"100482900","the-reducing-revisits-study-a-cluster-rct-100482900","NCT05568043","The Reducing REVISITS Study: A Cluster RCT","The Reducing Respiratory Emergency Visits Using Implementation Science Interventions Tailored to Setting (REVISITS) Study: A Cluster Randomized Trial","REVISITS","Since enrollment for Aim 2 will occur on a site\u002Fsystem-level, the inclusion of specific individuals who meet these criteria are not applicable since Aim 2 will only enroll hospital sites, not individuals. The sites the investigators enroll will represent diverse patient populations and geographical locations across the US.",{"count":108,"type":21},24,[110],"NA","This type II hybrid effectiveness-implementation trial will concurrently study the comparative effectiveness of virtual vs. in-person COPD care transition programs implemented via virtual mentored implementation approaches with and without co-design methods.\n\nThe investigators will enroll up to 24 randomized sites (with a goal minimum of 16 sites) to:\n\n* Deliver the COPD programs implemented via mentored support in collaboration with SHM Center for Quality Improvement.\n* Compare the effectiveness and penetration of virtual versus in-person COPD care transition programs implemented along with mentoring support with or without co-design.\n\nThe investigators aim to determine which combined approach(es) is\u002Fare the most effective at implementing evidence-based COPD program interventions and decreasing COPD acute care revisits with the greatest overall impact and sustainability.",[62,27],"2025-06-03",{"date":115,"type":34},"2025-06-06",{"date":117,"type":34},"2022-02-15",{"date":119,"type":21},"2026-03-31",{"name":121,"class":41},"University of Chicago",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":54,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100582915","study-on-acupuncture-treatment-of-chronic-airway-diseasesasthma-and-chronic-obstructive-pulmonary-disease-100582915","NCT06869525","Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease)","Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)","Inclusion Criteria:\n\n* Meets the diagnostic criteria for acute attack of asthma\u002FAECOPD;\n* Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);\n* The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.\n\nExclusion Criteria:\n\n* Patients with combined pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis and other pulmonary diseases;\n* Patients with severe cardiovascular and cerebrovascular diseases (such as malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.);\n* Patients with severe liver diseases (such as liver cirrhosis, portal hypertension and bleeding caused by esophageal and gastric fundus varices) and severe kidney diseases (such as dialysis, kidney transplantation, etc.);\n* Patients with impaired consciousness or various mental disorders who are unable to communicate normally;\n* Pregnant and lactating women;\n* Those who are currently participating in other clinical trials within 1 month before enrollment;\n* Patients with contraindications to acupuncture (such as severe allergic or infectious skin diseases);","80 Years",{"count":131,"type":21},576,[110],"For patients in the acute phase of chronic airway diseases, on the basis of guideline-directed treatment, the experimental group was given acupuncture treatment, while the control group was given sham acupuncture treatment. The treatment lasted for one week, followed by a 13-week follow-up. For asthma and COPD, PEF and CAT were respectively used as the primary outcome measures to evaluate the clinical efficacy and safety of acupuncture. Based on the improvement of the primary outcome measures, the advantageous population was identified. The mechanism by which acupuncture reduces airway mucus hypersecretion was preliminarily explained.",[27,135],"Asthma Acute",[27,135,137,138],"Acupuncture","Randomized Controlled Trial","2025-03-05",{"date":141,"type":34},"2025-03-11",{"date":143,"type":21},"2025-03",{"date":145,"type":21},"2027-12",{"name":147,"class":41},"Henan University of Traditional Chinese Medicine",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":54,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":42},"100541557","multiparametric-home-telemonitoring-of-patients-with-chronic-obstructive-pulmonary-disease-exacerbation-100541557","NCT06331416","Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation","Inclusion Criteria:\n\n1. Able to understand and sign the informed consent form.\n2. Already established diagnosis of COPD according to Global Initiative for Obstructive Lung Disease (GOLD) guidelines.\\[13\\]\n3. Diagnosis of COPD exacerbation at admission, according to GOLD guidelines.\\[13\\]\n4. Arterial partial pressure of oxygen (PaO2) \\\u003C 60 mmHg in ambient air at rest at admission and arterial partial pressure of oxygen (PaO2) \\> 60 mmHg in ambient air at rest at discharge, if not on long-term oxygen therapy on ventilation.\n5. Arterial partial pressure of oxygen (PaO2) \\\u003C 55 mmHg on usual oxygen supplement (L\u002Fmin) and arterial partial pressure of oxygen (PaO2) \\> 60 mmHg on oxygen supplement at discharge, if already on long-term oxygen therapy on ventilation.\n\ng) Age \\\u003C= 90 and \\>= 18 years old at randomization.\n\nExclusion Criteria:\n\n1. Heart failure as the main cause of acute respiratory failure\n2. Acute pulmonary embolism\u002Fchronic pulmonary thromboembolism\n3. Interstitial lung disease as the main cause of acute respiratory failure\n4. Pneumonia as the main cause of acute respiratory failure\n5. Chronic renal failure with dialysis dependence\n6. Immunosuppression (i.e. cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)\n7. Progressive neuro-muscular disorders\n8. Cognitively impaired, dementia or decompensated psychiatric disorder\n9. Quadriplegia\u002FHemiplegia or quadriparesis\u002Fhemiparesis\n10. Do-not-resuscitate order\n11. Any other condition that in the opinion of the investigator may significantly impact with patient's capability to comply with the protocol","90 Years",{"count":156,"type":21},60,[110],"Chronic obstructive pulmonary disease (COPD) exacerbations are risk factors for disease progression and short-term re- hospitalizations. We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline, symptoms, and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD.",[62,27],"2024-04-30",{"date":162,"type":34},"2024-05-02",{"date":164,"type":34},"2024-03-29",{"date":166,"type":21},"2026-09-30",{"name":168,"class":41},"University of Trieste",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":177,"targetDuration":179,"studyType":22,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":188,"locationsCount":42},"100495681","copd-icu-multicentre-prospective-observational-register-100495681","NCT05734365","COPD-ICU Multicentre Prospective Observational Register","Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of the Prognosis and the Factors Associated With Survival Multicentre Prospective Observational Register","COPD-ICU","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 syndrome (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, or a dedicated respiratory intensive 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":178,"type":21},500,"1 Year","COPD is one of the leading causes of morbidity, mortality and health care utilisation worldwide. Currently, COPD is the third leading cause of death worldwide and is therefore a major public health problem. Projections show an increase in the prevalence and burden of COPD in the coming decades due to ageing populations and continued exposure to risk factors.\n\nIn patients with COPD, mortality due to exacerbations is about 35%. Exacerbations represent the most important respiratory event in the history of this chronic disease and are of major socio-economic interest (about 50-75% of healthcare expenditure in this disease).\n\nIn the most severe cases, COPD exacerbations lead to respiratory distress with hypercapnic ventilatory acidosis requiring ventilatory support. These most severe episodes are common, accounting for 20% of exacerbations and are a signal of advanced disease, with a high risk of future hospitalisations and a limited long-term prognosis.\n\nDespite progress in management, the mortality of these severe acute exacerbations is around 15% in the ICU and 20% in hospital. The long-term prognosis following hospitalisation for an acute exacerbation of COPD is poor with a 5-year mortality of around 50%. On the one hand, the means and treatments likely to improve the prognosis of these patients are of great medical and socio-economic interest, on the other hand, it seems important to identify the elements that may be associated with management failure and to treat them where appropriate.\n\nThus, improving scientific knowledge thanks to prospective data, evaluating the different characteristics and prognosis of patients hospitalised for a severe acute exacerbation of COPD seems, in the 21st century, a major axis in order to continue to optimise the individual management of these patients but also collectively, given the COPD public health burden.",[27],"2023-02-16",{"date":184,"type":34},"2023-02-17",{"date":186,"type":34},"2022-11-01",{"date":145,"type":21},{"name":189,"class":41},"Versailles Hospital","Copd Exacerbation Acute"]