CTRI/2018/01/011441招募中不适用
Metabolic phenotype characterization of inflammatory cells in smoking and non-smoking COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Mitochondrial respiration in PBMCs of healthy and COPD patients
研究概览
简要总结
COPD is characterized by a lot of metabolic changes and we wanted to understand the changes in cellular metabolism in smoking and non-smoking COPD patients. We hypothesized that tobacco and biomass smoke are made up of different constituents and would affect the cells in different ways although both lead to COPD.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •ï‚· Healthy non-smoker o Be at least 40 years of age o Provide written informed consent o Never smoker and not exposed to biomass for >10 years o No major abnormality on clinical examination o Normal spirometry, FEV1/FVC>0.70 ï‚· Healthy smoker o Be at least 40 years of age o Provide written informed consent o Be smoking tobacco in the form of bidi or cigarettes for at least 10 pack years o No major abnormality on clinical examination o Normal spirometry, FEV1/FVC>0.70 4 ï‚· Healthy Biomass user o Be at least 40 years of age o Provide written informed consent o Be exposed to biomass for at least 10 fuel-years (exposure of 2hrs/day for 10 years) after adulthood o No major abnormality on clinical examination o Normal spirometry, FEV1/FVC>0.70 ï‚· Tobacco smoking COPD o Be at least 40 years of age o Provide written informed consent o Be smoking tobacco in the form or bidi or cigarettes for at least 10 pack-years o Have a clinical diagnosis of COPD (GOLD stage I to III) and post-bronchodilator FEV1/FVC ratio <0.70) ï‚· Non-smoking COPD o Be at least 40 years of age o Provide written informed consent o Be exposed to biomass for at least 10 fuel-years after adulthood o Have a clinical diagnosis of COPD (GOLD stage I to III): post-bronchodilator FEV1/FVC ratio <0.70) o Never smoker o FEV1 reversibility <400 mL to rule out asthma.
排除标准
- •Severe COPD patients would be excluded as the process of sputum induction may worsen their condition ï‚· History of lung condition other than COPD including respiratory infectious diseases like tuberculosis, asthma, interstitial lung disease, etc.
结局指标
主要结局
Mitochondrial respiration in PBMCs of healthy and COPD patients
时间窗: 1
次要结局
未报告次要终点
研究者
研究点 (1)
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