Study of inflammatory biomarkers in COPD and their association with co-morbidities
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is to determine the levels of inflammatory biomarkers in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Specifically, the focus is on measuring the levels of CRP (C-reactive protein), IL-6 (Interleukin-6), TNF-ALFA (Tumor Necrosis Factor Alpha), and fibrinogen in the blood samples of COPD patients. These biomarkers are chosen due to their established association with inflammation, and their levels may provide insights into the inflammatory processes occurring in COPD.
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a prevalent respiratory condition associated with systemic inflammation and various comorbidities, significantly impacting patients’ health outcomes. This study investigates the relationships between inflammatory biomarkers in COPD and their associations with comorbidities. By focusing on specific biomarkers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-ALFA), and fibrinogen, we seek to unravel the complex interplay between systemic inflammation, COPD severity, and the prevalence of comorbidities. This research is critical for advancing our understanding of the systemic manifestations of COPD and informing targeted interventions for improved patient management.
Methods: This cross-sectional observational study will be conducted at AVBRH, a tertiary care hospital in central India, over two years . A sample size of 90 COPD patients will be randomly selected based on inclusion and exclusion criteria. Diagnostic tests will be performed, including pulmonary function tests, chest X-rays, and biomarker assessments. Statistical analyses, encompassing chi-square tests, Pearson’s correlation coefficient, and logistic regression, will explore associations between inflammatory biomarkers, COPD severity, and comorbidities. The study design ensures rigorous data collection and adherence to ethical standards, with SPSS 27.0 utilized for statistical analyses.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are diagnosed cases of COPD in the department of respiratory medicine at AVBRH and age above 40 years.
排除标准
- •Patients not willing to give consent and non cooperative patients.
- •Patients having any connective tissue disorder like rheumatoid arthritis.
- •Patients having COPD asthma overlap.
结局指标
主要结局
The primary outcome of this study is to determine the levels of inflammatory biomarkers in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Specifically, the focus is on measuring the levels of CRP (C-reactive protein), IL-6 (Interleukin-6), TNF-ALFA (Tumor Necrosis Factor Alpha), and fibrinogen in the blood samples of COPD patients. These biomarkers are chosen due to their established association with inflammation, and their levels may provide insights into the inflammatory processes occurring in COPD.
时间窗: Assessment will be done every 6 months
次要结局
未报告次要终点
研究者
Aishwarya Kedar
Datta Meghe Institute of Higher Education and Research,Sawangi Meghe,Wardha,Maharashtra,442001,India
