CTRI/2019/04/018511尚未招募不适用
Systemic and local oxidative post-translational modification – S-glutathionylation in COPD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Identification of proteins modified by oxidative post translational modification in COPD patients
研究概览
简要总结
Oxidative stress is a hallmark characteristic of COPD but the limited success with current antioxidants indicates the lack of complete understanding of the mechanisms involved in the generation of this stress.Thus, the identification of proteins affected by this
oxidative stress as a result of tobacco and biomass smoke exposure will help us pinpoint the specific targets of this oxidative stress against which future therapies could be designed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy non-smoker Be at least 40 years of age Provide written informed consent Never smoker and not exposed to biomass for >10 years No major abnormality on clinical examination Normal spirometry, FEV1/FVC>0.70 (or IOS 80-120% predicted if not able to perform Spirometry) FEF25-75 > 65% DLCO ≥ 80% predicted Body plethysmography TLC ≥ 80% predicted Healthy smoker Be at least 40 years of age Provide written informed consent Be smoking tobacco in the form of bidi or cigarettes for at least 10 pack years No major abnormality on clinical examination Normal spirometry, FEV1/FVC>0.70 (or IOS 80-120% predicted if not able to perform Spirometry) FEF25-75 > 65% DLCO ≥ 80% predicted Body plethysmography TLC ≥ 80% predicted Healthy Biomass user Be at least 40 years of age Provide written informed consent Be exposed to biomass for at least 10 fuel-years (women)/ 20 fuel-years (men) (exposure of 2hrs/day for 10 years) after adulthood No major abnormality on clinical examination Normal spirometry, FEV1/FVC>0.70 (or IOS 80-120% predicted if not able to perform Spirometry) FEF25-75 > 65% DLCO ≥ 80% predicted Body plethysmography TLC ≥ 80% predicted Tobacco smoking COPD Be at least 40 years of age Provide written informed consent Be smoking tobacco in the form or bidi or cigarettes for at least 10 pack-years Have a clinical diagnosis of COPD (GOLD stage I to III) and post-bronchodilator FEV1/FVC ratio <0.70) (or IOS X > 1500 % predicted if not able to perform Spirometry) DLCO < 80% predicted Body plethysmography TLC < 80% predicted Non-smoking COPD Be at least 40 years of age Provide written informed consent Be exposed to biomass for at least 10 fuel-years (women)/ 20 fuel-years (men) after adulthood Have a clinical diagnosis of COPD (GOLD stage I to III): post-bronchodilator FEV1/FVC ratio <0.70) (or IOS (or IOS X > 1500 % predicted if not able to perform Spirometry)) DLCO < 80% predicted Body plethysmography TLC < 80% predicted Never smoker FEV1 reversibility <400 mL to rule out asthma.
排除标准
- •Subjects suffering from comorbidities such as diabetes.
- •Very Severe COPD patients would be excluded as the process of sputum induction may worsen their condition 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
Identification of proteins modified by oxidative post translational modification in COPD patients
时间窗: Not applicable as this is an observational study and does not involve an intervention.
次要结局
未报告次要终点
研究者
研究点 (1)
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