[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-exacerbation-chronic-obstructive-pulmonary-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-exacerbation-chronic-obstructive-pulmonary-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100654680","muscle-oxygenation-in-patients-with-copd-exacerbation-100654680",false,"NCT07801547","Muscle Oxygenation in Patients With COPD Exacerbation","Evaluation of Respiratory and Peripheral Muscle Oxygenation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\nAcute Exacerbation Group: 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. Hospital admission or presentation due to an acute exacerbation of COPD 3. Age 40 years or older 4. Voluntary agreement to participate with signed written informed consent Clinically Stable Group: 1. Diagnosis of COPD (GOLD Stage 1, 2, 3, or 4) 2. Age 40 years or older 3. Clinically stable condition for at least the past 4 weeks without acute exacerbations 4. Voluntary agreement to participate with signed written informed consent\n\nExclusion Criteria: Acute Exacerbation Group: 1. Active participation in a formal pulmonary rehabilitation program 2. Co-existing neurological disorders 3. Heart failure classified as New York Heart Association (NYHA) Class III or IV 4. Unstable mental or cognitive status (Mini-Mental State Examination \\[MMSE\\] score ≤24) 5. History of surgical intervention within the past three months 6. Presence of malignant conditions .\n\nClinically Stable Group: 1. History of lung cancer, sarcoidosis, tuberculosis, and\u002For prior lung surgery 2. Known mental or cognitive impairment.","ALL","40 Years",{"count":19,"type":20},40,"ESTIMATED","1 Day","OBSERVATIONAL","Chronic obstructive pulmonary disease (COPD) is often complicated by acute exacerbations, which lead to functional impairments, increased dyspnea, and a rapid decline in lung function. During an exacerbation, impaired pulmonary gas exchange, systemic inflammation, and increased work of breathing significantly alter oxygen availability and metabolic demand in skeletal muscles. The aim of this study is to evaluate and compare respiratory and peripheral muscle oxygenation in patients with acute exacerbation of COPD (AECOPD) and patients with clinically stable COPD. By examining these physiological changes, the study seeks to determine the impact of exacerbations on muscle function and oxygenation efficiency",[25,26,27],"COPD (Chronic Obstructive Pulmonary Disease)","Acute Exacerbation Chronic Obstructive Pulmonary Disease","Muscle Oxygenation","NOT_YET_RECRUITING","2026-08-28",{"date":31,"type":32},"2026-09-03","ACTUAL",{"date":34,"type":20},"2026-08-30",{"date":36,"type":20},"2028-02-05",{"name":38,"class":39},"Hacettepe University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100628018","phase-3-effect-of-low-dose-versus-high-dose-alpha-lipoic-acid-on-oxidative-stress-inflammation-and-clinical-outcomes-in-acute-exacerbations-of-chronic-obstructive-pulmonary-disease-100628018","NCT07456176","Effect of Low-Dose Versus High-Dose Alpha-Lipoic Acid on Oxidative Stress, Inflammation, and Clinical Outcomes in Acute Exacerbations of Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n\\- Confirmed diagnosis of COPD, supported by a previous spirometry report showing: Post-bronchodilator FEV₁\u002FFVC \\\u003C 0.70, consistent with GOLD criteria for persistent airflow limitation.\n\n* History of frequent exacerbations, defined as two or more COPD exacerbations per year during the two years prior to enrollment.\n* An exacerbation of COPD is an acute event characterized by increased dyspnea and\u002For cough and sputum that worsens within ≤14 days and often results in additional therapy, according to the most recent GOLD guidelines.\n\nExclusion Criteria:\n\n* • Known allergy or intolerance to ALA.\n\n  * Cystic fibrosis or bronchiectasis.\n  * Patients with a history of asthma, pneumonia, interstitial lung disease, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease\n  * Active or recent infection with tuberculosis.\n  * Any other significant comorbid condition that could interfere with study participation or outcomes (e.g., severe liver or kidney disease, uncontrolled cardiovascular disease).","18 Years","70 Years",{"count":50,"type":20},75,"INTERVENTIONAL",[53],"PHASE3","Chronic Obstructive Pulmonary Disease (COPD) is a progressive inflammatory lung disease characterized by persistent airflow limitation and enhanced oxidative stress. Acute exacerbations of COPD (AECOPD) significantly increase morbidity, accelerate lung function decline, and worsen clinical outcomes. Oxidative stress plays a central role in AECOPD pathophysiology by amplifying inflammation through mediators such as IL-8 and TNF-α, leading to airway injury and impaired gas exchange.\n\nAlpha Lipoic Acid (ALA) is a potent antioxidant and anti-inflammatory agent that scavenges reactive oxygen species, regenerates endogenous antioxidants, and modulates redox-sensitive inflammatory pathways. Although preclinical evidence supports its protective role in respiratory diseases, no randomized clinical trial has evaluated ALA in AECOPD or compared different dosing strategies.\n\nAim\n\nThis study aims to evaluate and compare the effects of low-dose (600 mg\u002Fday) versus high-dose (1200 mg\u002Fday) ALA on oxidative stress markers, inflammatory biomarkers, clinical recovery, pulmonary oxygenation, gas exchange, and safety in patients with AECOPD.\n\nMethods\n\nThis is a prospective, double-blind, randomized controlled trial conducted in the ICU at El Matareya Teaching Hospital. Adult patients (40-70 years) with confirmed COPD and frequent exacerbations were randomized (1:1:1) into three groups:\n\nGroup A: Standard therapy + placebo\n\nGroup B: Standard therapy + 600 mg\u002Fday oral ALA\n\nGroup C: Standard therapy + 1200 mg\u002Fday oral ALA\n\nAll patients received guideline-based AECOPD management according to GOLD recommendations, including bronchodilators, systemic corticosteroids, antibiotics (when indicated), oxygen therapy, and ventilatory support as needed.\n\nAssessments\n\nBaseline and Day 10 evaluations included:\n\nPrimary Outcomes:\n\nOxidative stress marker: Malondialdehyde (MDA)\n\nInflammatory markers: Interleukin-8 (IL-8) and C-reactive protein (CRP)\n\nSecondary Outcomes:\n\nTime to clinical stability\n\nICU and hospital length of stay\n\nNeed for non-invasive or invasive ventilation\n\nEarly relapse (14 days) and 30-day readmission\n\nGas Exchange: ABGs (pH, PaO₂, PaCO₂, P\u002FF ratio)\n\nPatient-Reported Outcomes: COPD Assessment Test (CAT) and mMRC dyspnea scale\n\nSafety: Monitoring for adverse effects including gastrointestinal symptoms, hypoglycemia, dizziness, and hypersensitivity reactions.",[26],[57,58,59],"Acute exacerbations of COPD","Alpha lipoic acid","adjuvant therapy","2026-03-25",{"date":62,"type":32},"2026-03-30",{"date":64,"type":20},"2026-02-28",{"date":66,"type":20},"2026-06-01",{"name":68,"class":39},"Ain Shams University",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":51,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":40},"100602603","phase-2-intravenous-alpha-1-antitrypsin-for-hospitalized-patients-with-copd-exacerbations-aecopd-study-100602603","NCT07125664","Intravenous Alpha-1 Antitrypsin for Hospitalized Patients With COPD Exacerbations (AECOPD Study)","A Two-center, Randomized, Double-blind, Placebo-controlled Study of Intravenous Plasma-purified Alpha-1 Antitrypsin for Hospitalized Patients With COPD Exacerbations (AECOPD Study)","Inclusion Criteria:\n\n1. Informed Consent as documented by signature\n2. Male and female ≥40 years old\n3. Previous COPD diagnosis with a documented post-bronchodilator FEV1 to FVC ratio (FEV1\u002FFVC) equal to or less than 0.70 or LLN\n4. Hospitalized for a moderate to severe exacerbation, according to the Rome proposal\n5. Admission to the respiratory ward by ≤24 hours\n6. Acute respiratory failure with SpO2 \\\u003C92% at room air, or PaO2\\\u003C 60 mmHg at room air, or acute on chronic respiratory failure defined as higher Increased oxygen requirements compared with the home standard oxygen prescription\n7. A positive sputum NEATstik®, that corresponds to an approximate neutrophil elastase concentration of 8 μg·mL-1 (rapid point-of-care test)\n\nExclusion Criteria:\n\n1. Clinically important pulmonary disease other than COPD (e.g., clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, and primary ciliary dyskinesia)\n2. Presence of pneumonia or other pleuroparenchymal abnormalities on either chest X-ray or Chest CT scan, performed per routine clinical practice at the hospital admission\n3. Current diagnosis of asthma according to the GINA, prior history of asthma, or asthma-COPD overlap\n4. Known AATD as homozygous or composite heterozygous mutation\n5. Presence of any active malignancy (other than non-melanoma skin cancer)\n6. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and\u002For cognitive impairment that, in the opinion of the Investigator, could:\n\n   1. Affect the safety of the participant throughout the study\n   2. Influence the findings of the study or their interpretation\n7. Known diagnosis of selective IgA deficiency defined as a serum IgA of less than 7 mg\u002Fdl (0.07 g\u002FL)\n8. Patient with the immediate need for ETI of NIV (patients already on CPAP or NIV can be included)\n9. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product\n10. Women who are of childbearing potential\\*\n11. Participants that have previously received Prolastin® 1000 mg\u002F40 ml\n12. Participation in another interventional clinical trials with investigational drugs within the 30 days preceding and during the present study. \\* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the randomisation without an alternative medical cause.",{"count":77,"type":20},36,[79],"PHASE2","Intravenous augmentation therapy with purified preparations of AAT (Alpha1-antitrypsin) derived from human plasma is a well consolidated specific therapeutic option to treat the severe deficient state of AAT. Prolastin is used to restore the balance between AAT and elastases in the lung and consequently to prevent a further deterioration in the pulmonary emphysema. Recently, in patients with COVID-19, without genetically lowered AAT levels with moderate to severe ARDS, treatment with AAT was demonstrated to be safe, feasible, and biochemically efficacious as an anti-inflammatory therapeutic therapy.\n\nThe aim of the study, based on biological plausibility, is to evaluate the safety and efficacy (from a biological perspective) of the administration of intravenous plasma-purified AAT as an anti-inflammatory treatment for patients admitted to hospital because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure.\n\nThirty-six adult patients hospitalized because of a COPD exacerbation leading to an acute or an acute on chronic respiratory failure will be enrolled by the two sites involved in the study, the Pneumology Unit of Fondazione IRCCS Policlinico San Matteo (Pavia, Italy) and the Pneumology Unit of IRCCS Istituto Clinico Humanitas, Rozzano (Milano, Italy).\n\nParticipants will be randomized 2:1 in the active treatment group (standard treatment + IV administration of Prolastin) or in the placebo group (standard treatment+ IV administration of 0.9% sodium chloride).\n\nTo address the clinical question from a biological perspective, we will investigate the decrease in inflammatory markers in the active treated group in comparison with the placebo group.\n\nThe primary objective is to demonstrate a significant reduction in systemic inflammation by IV Prolastin administered once at 120 mg per kilogram of body weight in patients with moderate to severe AECOPD, as assessed by the change in plasma concentration of IL6 at 7 days after randomization, in the active treatment group with respect to placebo group.\n\nSecondary outcomes are:\n\n1. Difference in change in plasma concentration of IL-1b, IL-5, IL-8, IL-10, and soluble TNF receptor 1 (sTNFR1), CRP at 7 days after randomization.\n2. Differences in AAT antielastase activity, the amount of active elastase, the AAT levels in serum at baseline and at 7 days after randomization.\n3. Difference in treatment failure rate. Treatment failure is a composite endpoint of need for either NIV or CPAP or need of ETI or need of transfer to ICU or in-hospital death after randomization\n4. Impact of AECOPD on overall health, daily life, and perceived well-being in patients with obstructive airways disease by the change of St. George's Respiratory Questionnaire (SGRQ) score from Day 7 to follow-up (30 days after hospital discharge).\n5. Differences in type and number of AEs and SAEs in the two groups\n\nThe expected duration of subject participation is from randomization to 30 days after hospital discharge, with a follow up phone contact.",[26],[83,84,85,86],"COPD exacerbations","Intravenous alpha-1 antitrypsin","IL-6","anti-inflammatory","2025-08-19",{"date":89,"type":32},"2025-08-24",{"date":91,"type":20},"2025-10-01",{"date":93,"type":20},"2027-12-01",{"name":95,"class":39},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":51,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":40},"100575981","mxa-and-crp-guided-use-of-antimicrobial-agents-for-aecopd-100575981","NCT06779344","MxA and CRP-Guided Use of Antimicrobial Agents for AECOPD","Myxovirus Resistance Protein a and C-Reactive Protein-Guided Antimicrobial Treatment in Outpatients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* ≥40 years old；\n* Current or former smoker with a minimum smoking history of 10 pack years, clinical diagnosed with mild-to-severe COPD;\n* Presenting with an acute exacerbation of COPD\n* The severity of AECOPD is mild to moderate.\n\nExclusion Criteria:\n\n* Required urgent hospitalization\n* Received interferon therapy within 30 days before screening\n* Had an active systemic inflammatory condition within 30 days prior to screening, such as cerebral infarction, myocardial infarction, or surgery\n* Received vaccine in the past 30 days\n* Active tuberculosis\n* Immunocompromised\n* Presenting with current respiratory failure\n* Clinical suspicion of pneumonia or pulmonary edema.\n* Coexisting bronchiectasis, cystic fibrosis, or asthma\n* Had a concurrent infection at another site, such as urinary tract infections or sinusitis;\n* Contraindications to antibiotics and\u002For antivirals\n* Known etiology of the present exacerbation\n* Pre-treatment with corticosteroids (cumulative dose of methylprednisolone ≥ 80 mg or equivalent dose) for the present exacerbation.",{"count":104,"type":20},458,[106],"NA","This randomized controlled trial will investigate the clinical impact of Myxovirus Resistance A (MxA) and C-Reactive Protein (CRP)-guided antimicrobial treatment compared to usual care in outpatients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).",[26],"2025-01-11",{"date":111,"type":32},"2025-01-16",{"date":113,"type":20},"2025-01-13",{"date":115,"type":20},"2026-12-31",{"name":117,"class":39},"Capital Medical University"]