[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628018":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":36,"studyPopulation":16,"armGroups":37,"interventions":55,"overallOfficials":16,"centralContacts":16,"locations":67,"responsibleParty":89,"collaborators":16,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":16,"eligibilityCriteria":97,"healthyVolunteers":94,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":16,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":114,"whyStopped":16,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ain Shams University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Oxidative Stress & Inflammatory Biomarkers","* Malondialdehyde (MDA)\n* Interleukin-8 (IL-8)","Measured at baseline (Day 0) and Day 10",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Length of hospital stay",null,"From the date of randomization until hospital discharge, assessed during the index hospitalization for up to 30 days after randomization.",{"measure":19,"description":20,"timeFrame":21},"COPD Assessment Test (CAT) score","The COPD Assessment Test (CAT) is a simple, validated 8-item questionnaire used to assess the impact of Chronic Obstructive Pulmonary Disease on a patient's health status and daily life.","It will be assessed at baseline of the study and after 10 days",{"measure":23,"description":24,"timeFrame":25},"Clinical stability","Clinical stability: Defined as the time from initiation of the study intervention until the patient achieves clinical stability, characterized by meeting all of the following criteria and maintaining them for at least 24 consecutive hours:\n\n* Resolution of fever: Temperature ≤ 37.5°C\n* Stable hemodynamics: Heart rate ≤ 100 beats\u002Fmin and systolic blood pressure ≥ 90 mmHg\n* Stable respiratory status: Respiratory rate ≤ 24 breaths\u002Fmin\n* Improved oxygenation: Oxygen saturation ≥ 90% on room air or stable supplemental oxygen (or baseline if known to be lower)\n* No need for rescue medications beyond the scheduled regimen","From the date of randomization until the date clinical stability is first achieved and maintained for at least 24 consecutive hours, assessed daily during hospitalization for up to 10 days after randomization.",{"allocation":27,"interventionModel":28,"interventionModelDescription":16,"primaryPurpose":29,"observationalModel":16,"timePerspective":16,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":16,"whoMasked":32},"TRIPLE",[33,34,35],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Acute exacerbations of chronic obstructive pulmonary disease (COPD) are characterized by an acute intensification of airway inflammation and oxidative stress, resulting in worsening airflow limitation, impaired gas exchange, and increased risk of morbidity and healthcare utilization. Oxidative stress is a key contributor to exacerbation pathophysiology, driven by excess generation of reactive oxygen species, depletion of endogenous antioxidant defenses, activation of redox-sensitive transcription pathways, and upregulation of pro-inflammatory mediators. These processes promote neutrophilic airway inflammation, epithelial damage, mucus hypersecretion, and decline in pulmonary function.\n\nAlpha-lipoic acid (ALA) is an endogenous mitochondrial cofactor with established antioxidant and anti-inflammatory properties. It functions through redox cycling, direct scavenging of reactive oxygen species, regeneration of intracellular antioxidants (including glutathione), and modulation of redox-sensitive signaling pathways involved in inflammation. Although preclinical studies have demonstrated protective effects of ALA in models of oxidative lung injury, its clinical role in acute exacerbations of COPD has not been established.\n\nThis study is a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the adjunctive use of ALA in patients hospitalized with acute exacerbations of COPD. Participants will be randomized in a 1:1:1 ratio to receive placebo, ALA 600 mg\u002Fday, or ALA 1200 mg\u002Fday for 10 days, in addition to standard-of-care therapy in accordance with current guideline-based management. The intervention period aligns with the typical duration of acute-phase pharmacologic treatment and is intended to capture early biochemical and clinical responses.\n\nThe trial is designed to assess potential dose-response effects by comparing two dosing regimens of ALA against placebo under standardized treatment conditions. Randomization will be computer-generated with allocation concealment ensured through identical-appearing study medications to maintain blinding of participants, healthcare providers, and outcome assessors.\n\nThe primary objective is to evaluate the effect of adjunctive ALA on systemic oxidative stress and inflammatory biomarkers during the acute treatment period. Secondary objectives include assessment of clinical recovery parameters, respiratory function and gas exchange indices, symptom burden, healthcare utilization, and safety outcomes. Time to clinical stability will be evaluated using predefined objective physiological criteria.\n\nSafety monitoring will include assessment of known potential adverse effects associated with ALA, including gastrointestinal symptoms, hypoglycemia, neurological manifestations, and hypersensitivity reactions. All adverse events will be recorded and evaluated for severity and causality.\n\nThe sample size has been calculated to detect clinically meaningful differences in oxidative stress markers between groups with 90% statistical power, accounting for multiple comparisons. Statistical analyses will be conducted using an intention-to-treat approach with appropriate adjustments for multiple testing.\n\nThis study aims to provide randomized clinical evidence on the efficacy and dose-dependent effects of alpha-lipoic acid as an adjunctive therapy in acute exacerbations of COPD, targeting the oxidative-inflammatory pathway to improve biochemical and clinical outcomes.",[38,44,49],{"label":39,"type":40,"description":41,"interventionNames":42},"Low dose Alpha lipoic acid","ACTIVE_COMPARATOR","Patients in this group will receive standard AECOPD therapy in addition to 600 mg of oral ALA per day for 10 days",[43],"Drug: Alpha Lipoic Acid 600 MG Oral Tablets",{"label":45,"type":40,"description":46,"interventionNames":47},"High dose Alpha lipoic acid","Patients in this group will receive standard AECOPD therapy in addition to 1200 mg of oral ALA per day for 10 days",[48],"Drug: Alpha Lipoic Acid",{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo","PLACEBO_COMPARATOR","Patients in this group will receive standard therapy for AECOPD along with matching placebo capsules administered orally for 10 days.",[54],"Drug: Placebo",[56,61,65],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":16},"DRUG","Alpha Lipoic Acid 600 MG Oral Tablets","Alpha lipoic acid tablets 600 mg",[39],{"type":57,"name":62,"description":63,"armGroupLabels":64,"otherNames":16},"Alpha Lipoic Acid","Alpha lipoic acid tablets 1200 mg",[45],{"type":57,"name":50,"description":52,"armGroupLabels":66,"otherNames":16},[50],[68],{"facility":69,"status":16,"city":70,"state":16,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Matareya Teaching Hospital","Cairo","11856","Egypt","EG",{"type":75,"coordinates":76},"Point",[77,78],31.24967,30.06263,{"lat":78,"lon":77},[81,86],{"name":82,"role":83,"phone":84,"phoneExt":16,"email":85},"Amir Eskander Hanna, MD","CONTACT","+201227933624","amireskanderhanna@gmail.com",{"name":87,"role":88,"phone":16,"phoneExt":16,"email":16},"Mariam Elsayed, Bachelor of Pharmacy","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Eman Mohamed El Mokadem","Lecturer of Pharmacy Practice and Clinical Pharmacy","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",false,"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).","ALL","18 Years","70 Years",{"count":102,"type":103},75,"ESTIMATED","INTERVENTIONAL",[106],"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.",[109],"Acute Exacerbation Chronic Obstructive Pulmonary Disease",[111,112,113],"Acute exacerbations of COPD","Alpha lipoic acid","adjuvant therapy","NOT_YET_RECRUITING","2026-03-25",{"date":117,"type":118},"2026-03-30","ACTUAL",{"date":120,"type":103},"2026-02-28",{"date":122,"type":103},"2026-06-01",{"name":5,"class":6},1]