Adjunctive Role of Statin Therapy on Airway Inflammation and Clinical Consequences of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- assessment of complete blood count
研究概览
简要总结
This study aimed to evaluate the impact of statin therapy on the clinical consequences, as well as airway inflammation and radiological features, in severe chronic obstructive pulmonary cases.
详细描述
Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow obstruction due to chronic respiratory symptoms and abnormalities in the airways and alveoli. Despite new treatment developments, mortality rates remain high in both developed and developing countries. Chronic airway inflammation significantly contributes to Chronic obstructive pulmonary disease, with statins like atorvastatin showing potential benefits beyond lipid lowering. Observational studies suggest statins may reduce exacerbations and mortality; however, systematic reviews indicate inconsistent clinical benefits. A 2023 meta-analysis noted possible improvements in lung function and inflammation but called for more rigorous trials. A recent 2024 study indicated a minimal impact of statins on exacerbation risk in patients with cardiovascular comorbidities, highlighting ongoing controversy. In light of these findings, a focused randomized trial is proposed for GOLD Group E chronic obstructive pulmonary disease patients at higher exacerbation risk, testing atorvastatin's effectiveness on various outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Chronic Obstructive Pulmonary Disease per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria 2025 (post-bronchodilator forced expiratory volume₁/forced vital capacity < 0.70), meets the definition of grade E Chronic Obstructive Pulmonary Disease by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria 2025 criteria.
- •Age ≥ 40 years
排除标准
- •Chronic lung diseases other than COPD as bronchial asthma, interstitial lung disease
- •Acute or chronic Inhalational lung injury.
- •Established indication for statin therapy (atherosclerotic cardiovascular disease, familial hyperlipidemia).
- •Chronic debilitating diseases as diabetes mellitus, chronic liver disease, chronic kidney disease, and hematological disorders.
- •Pregnancy/lactation.
- •Known hypersensitivity to statins.
- •Unable or refuse to provide informed consent.
研究组 & 干预措施
Statin group
which includes 40 chronic obstructive pulmonary disease cases (grade E) who received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months)
干预措施: Statin (Drug)
non Statin group
which includes 40 COPD (grade E) cases who did not receive statin
干预措施: placepo intervention (Other)
结局指标
主要结局
assessment of complete blood count
时间窗: baseline - 1 month - 6 months
A Complete Blood Count (CBC) is measured using an automated hematology analyzer to quantify different components of blood. A brief description suitable for a research paper could be: Blood samples were collected in EDTA-anticoagulated tubes and analyzed using an automated hematology analyzer. The complete blood count (CBC) parameters, including hemoglobin concentration, red blood cell (RBC) count, white blood cell (WBC) count, hematocrit (HCT), platelet count, and red cell indices (MCV, MCH, MCHC), were measured according to the manufacturer's instructions. Quality control procedures were performed daily to ensure accuracy and reliability of results.
assessment of Liver function
时间窗: baseline - 1 month - 6 months
Blood samples were collected and centrifuged to obtain serum. Liver function tests were performed using an automated biochemistry analyzer according to the manufacturer's instructions. The measured parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, serum albumin, and total protein. Internal quality control procedures were carried out to ensure the accuracy and reliability of the results.
assessment of Kidney function
时间窗: baseline - 1 month - 6 months
Blood samples were collected and centrifuged to obtain serum. Kidney function tests were performed using an automated biochemistry analyzer according to the manufacturer's instructions. The measured parameters included serum creatinine, blood urea (urea nitrogen), and uric acid. Estimated glomerular filtration rate (eGFR) was calculated using an appropriate equation. Internal quality control procedures were applied to ensure the accuracy and reliability of the results.
assessment of Erythrocyte sedimentation rate.
时间窗: baseline - 1 month - 6 months
"For measurement of erythrocyte sedimentation rate (ESR), venous blood was collected in an anticoagulant-containing tube and transferred into a vertically positioned Westergren tube. The distance that red blood cells sedimented after 1 hour was recorded in mm/hour."
assessment of C-reactive protein
时间窗: baseline - 1 month - 6 months
"C-reactive protein (CRP) was measured from a venous blood sample using a standard laboratory immunoassay technique, and the value was recorded in mg/L as an indicator of systemic inflammation."
assessment of Serum eosinophil level.
时间窗: baseline - 1 month - 6 months
"Serum eosinophil count was determined from venous blood samples using an automated hematology analyzer and expressed as cells per microliter (cells/µL)."
次要结局
- assessment of the delta change forced expiratory volume1 gradient(baseline - 1 month - 6 months)
- assessment of Peak expiratory flow rate(baseline - 1 month - 6 months)
- assessment of degree of hyperinflation of lung(baseline - 1 month - 6 months)
研究者
Mohamed Salah El-Sayed
principal investigator
Horus University