EU-COAST STUDY: European Cost of Asthma Treatment Economic Impact of Asthma Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,752
- 试验地点
- 1
- 主要终点
- health care costs related to asthma according to the patients' asthma control level
研究概览
简要总结
The economic cost of asthma is considerable both in terms of direct medical costs (such as the cost of pharmaceuticals and hospital admissions) and indirect medical costs (such as time lost from work and premature death).
The costs of asthma depend on the severity of disease and the extent to which exacerbations are avoided. Moreover, poor control of asthma symptoms is a major issue that can result in adverse clinical and economic outcomes.
According to GINA guidelines, the goal of asthma treatment is to achieve and maintain asthma control. Such an objective can be reached in a majority of patients with a pharmacologic intervention strategy developed in partnership between the patient/family and the doctor. Validated measures for assessing asthma control score goals as continuous variables and provide numerical values to distinguish different levels of control. Among them, the Asthma Control Test (TM - QualityMetric Incorporated) is widely recognized. Few data exist on the relationship between asthma control and health care consumption.
Some models for predicting asthma costs have been proposed. However, these models only attempt to assess costs associated with medications and/or asthma exacerbations. Furthermore, in such studies, asthma control was not defined accordingly to current international criteria.
Considering the increasing interest of health authorities in reducing asthma associated costs and improving quality of care, it appears necessary to study the relationship between the cost and the level of control.
详细描述
A European observational retrospective bottom-up cost of illness study will be designed based upon a sample of patients with asthma. Investigators will be general practitioners.
They will have to enrol a sample of patients with asthma.
The level of asthma control will be evaluated with 2 methods:
- Firstly by using the auto-test Asthma Control Test (TM - QualityMetric Incorporated) which allows to assess the level of control on a 4-week period by distinguishing controlled and uncontrolled patients ;
- Secondly by using the GINA's asthma control criteria to measure the level of control in the last 3 months. The GINA classification will allow ranging patients in 3 groups (controlled, partly controlled and uncontrolled patients) and comprises a measure of lung function using a peak expiratory flow measurement (PEF) or a spirometric examination.
The study design will necessitate only one visit per patient with a retrospective data collection over a three-month period. This period is the maximum possible retrospective duration to avoid memory biases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients, male or female aged ≥ 18 ;
- •Patient diagnosed with asthma for at least 12 months and at least one antiasthmatic treatment in the last 12 months;
- •Patient has read the information letter and the informed consent (if applicable).
排除标准
- •Patient already included in this study;
- •Patient who participated into a clinical trial during the last 6 months;
- •Patient aged >=45 with an history of smoking of at least 20 packs-year;
- •Patient with a chronic obstructive bronchopneumopathy
- •Pregnant women.
结局指标
主要结局
health care costs related to asthma according to the patients' asthma control level
时间窗: 1 year
次要结局
- Direct costs and indirect costs of consumed resources(1 year)
- Costs directly associated with asthma care and costs associated with asthma complications (exacerbations);(1 year)
- Healthcare costs related to asthma (by control) and concomitant diseases(1 year)