Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- 1-year adverse evolution
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD), , secondary to smoking, is a major public health issue with very high direct and indirect costs. The impact on the health system of undiagnosed patients, up to 70% of patients, is increasingly documented. However, systematic spirometry screening remains controversial among smokers in the absence of data to link the detection of new patients with improved management and clinical events and health goals. More generally, there is little data on the evolution of patients in real life once they have entered the care system.
The premise is that with systematic screening in general medicine, it is possible to identify the evolution of newly diagnosed COPD patients, to distinguish the different possible evolutions according to the initial phenotype and the management.
详细描述
A description of the population from which the groups or cohorts will be selected Smokers who have a screening spirometry for COPD, either in general medicine, at a pulmonologist or in the CHIC or Henri Mondor hospital respiratory function tests department.
After screening, an equal number of men and women COPD will be included (150 men and 150 women). 1500 smokers will be included to reach 300 smokers with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria of smokers with spirometry (pre-inclusion)
- •Age> 35 years
- •Smoking > 20 PA
- •Active smoking (cessation < 1 month)
- •Signature of consent to participate in Phase I of the study
- •Inclusion criteria for patients with incidental COPD
- •FEV1 / FVC <70% of the theoretical value and / or <LLN (Lower limit of normal)
- •Signature of consent to participate in Phase II of the study
排除标准
- •Known COPD
- •Cancer being treated
- •No affiliation to the social security or other social protection scheme
- •Pregnant or lactating woman
- •Patient deprived of liberty or under legal protection (under tutorship or curatorship
结局指标
主要结局
1-year adverse evolution
时间窗: at 12 Months
1-year adverse evolution defined by a composite criterion associating: - Occurrence of an additional exacerbation defined by any event requiring the use of the care system (visit to the doctor, emergencies, or hospitalization, for respiratory aggravation) with prescription of antibiotics or systemic steroids AND/OR - Increased dyspnea by 1 point on the MMRC dyspnea score AND/OR - CAT\> 10 or 2 points increase on CAT symptom scores
次要结局
- Adverse evolution(at 3 Months and 6 Months)
- DLCO / Respiratory function parameters(at 12 Months)
- Residual volume / Respiratory function parameters(at 12 Months)
- Arterial stiffness(at 12 Months)
- Numbers of deaths(at 12 Months)
- Exacerbation(at 3 Months, 6 Months and 12 Months)
- FEV 1 / Respiratory function parameters(at 12 Months)
- Total lung capacity / Respiratory function parameters(at 12 Months)
- Skeletal muscle index(at 12 Months)
- Number of steps(at 3 Months, 6 Months and 12 Months)
- Forced Expiratory Volume in one second (FEV1)(at 3 Months, 6 Months and 12 Months)
- Hospital Anxiety and Depression scale(at 12 Months)
- Diastolic dysfunction / Echocardiography(at 12 Months)
- PAPS / Echocardiography(at 12 Months)
- Muscle function(at 12 Months)
- LVEF / Echocardiography(at 12 Months)