2025-524821-42-00招募中4 期
Erdosteine effect on oxidative stress, inflammatory response and immune modulation in patients with COPD. A single center, open label, double arm, controlled, 4-week, explorative, ex vivo study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference from baseline in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme quantification in peripheral blood after 30 days of treatment with erdosteine+ standard of care.
研究概览
简要总结
To investigate changes of transcriptomic and secretomic profile of GPX2 (glutathione peroxidase 2) in COPD patients exposed to erdosteine + standard of care.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45 years
- •A spirometrically confirmed COPD diagnosis (post bronchodilator FEV1/FVC <0.7) dating at least 12 months from enrollment
- •Stable clinical conditions, defined as no exacerbations or respiratory infections of any severity in the last 3 months before enrollment
- •Moderate to Severe airflow obstruction (FEV1 30-80 %predicted post bronchodilation)
- •No hospitalizations for any cause in the 3 months prior to enrollment
- •Ability to perform repeatable pulmonary function tests
- •Chronic inhaled therapy with LAMA/LABA or LAMA/LABA/ICS with no changes in dosage in the last 3 before enrollment
- •Ex smokers with a smoking history of at least 10 pack years (1 pack year equals to 20 cigarettes smoked per day per 10 years)
- •Male or female gender
排除标准
- •NYHA class III and IV heart failure
- •Chronic renal failure with creatinine clearance <25 mL/min
- •Active smokers or never smokers
- •Any signs suggestive or positive history for an active systemic or respiratory infection in the last 3 months prior to screening and enrollment
- •Ongoing therapy, irrespective of the regimen, with any mucolytic/antioxidant agents, including, but not limited to: erdosteine, N-acetylcysteine, carbo-cysteine, ambroxol, bromhexine.
- •Known allergy or hypersensitivity to erdosteine or to any component of the study drug
- •Women of Childbearing Potential (WOCBP)
- •Unstable arrhythmia
- •Active malignancy (solid or blood)
- •Chronic treatment with systemic corticosteroids or immunosuppressants
- •Immune depression
- •Known hypersensitivity to erdosteine
- •Pregnancy or breastfeeding
- •Active peptic ulcer
- •Hepatic insufficiency, liver cirrhosis or known cystathionine-synthase deficiency
研究组 & 干预措施
ESTECLIN 300 MG CAPSULE RIGIDE
Test
干预措施: ESTECLIN 300 MG CAPSULE RIGIDE (Drug)
结局指标
主要结局
Difference from baseline in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme quantification in peripheral blood after 30 days of treatment with erdosteine+ standard of care.
Difference from baseline in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme quantification in peripheral blood after 30 days of treatment with erdosteine+ standard of care.
次要结局
- Difference between baseline and end of treatment in relative GPX2 (glutathione peroxidase 2) expression and GPX2 enzyme concentration in peripheral blood in patients exposed to Erdosteine + Standard of Care (Treatment arm A) and patients not exposed to Erdosteine (Treatment arm B).
- Difference from baseline after 30 days of treatment in relative expression and concentration of immune response pathways related cytokines/chemokines and oxidative stress mediators in peripheral blood of patients exposed to Erdosteine + Standard of Care (Treatment arm A).
- Difference from baseline after 30 days of treatment in relative expression and concentration of immune response pathways related cytokines/chemokines and oxidative stress mediators in peripheral blood of patients exposed to Erdosteine + Standard of Care (Treatment arm A) compared with patients treated with Standard of Care (Treatment arm B).
- Difference from baseline after 30 days of treatment in functional characterization by means of flow cytometry of Th 1 (CD4/T-bet/IFN-γ/IL-2), Th 17 (CD4/Rorγt/IL-17/IL-21) and Treg (CD4/C25/Foxp3/IL-10/TGF-β/CTLA-4) in peripheral blood of patients exposed to Erdosteine + Standard of Care (Treatment arm A) compared with patients treated with Standard of Care (Treatment arm B).
研究者
Principal Investigator
Scientific
ASST Fatebenefratelli Sacco
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
The Correlation and Mechanistic Study of GGCX Gene With Prognosis in Acute Ischemic StrokeNCT07269288Peking University Aerospace Center Hospital1,500
招募中
不适用
Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm NeonatesNCT07338370Ain Shams University34
已完成
不适用
Research on the conversion of cotinine back into nicotine in human plasmaCTRI/2024/02/062598Sri Ramachandra Institute of Higher Education and Research DU168
招募中
不适用
Glycocalyx and Oxidative Stress in Endothelial Function (Part 2)Coronary Heart DiseaseNCT07451873Josip Juraj Strossmayer University of Osijek35
尚未招募
4 期
A study to compare a new anti-oxidant medicine Astaxanthin with standard Anti-oxidant medicine (Capsule SM Fibro)in the treatment of Oral Submucous Fibrosis in adults.CTRI/2026/01/100292Dr Janice John114