Epi-Asthma: Prevalence and Characterisation of Asthma Patients According to Disease Severity in Portugal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 842
- 试验地点
- 1
- 主要终点
- Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma
研究概览
简要总结
This study aims to determine the prevalence of Asthma, Difficult-to-Treat and Severe Asthma in Portugal, and characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.
详细描述
Data on the epidemiology of asthma in Portugal were mainly grounded in studies using questionnaires and covering limited age groups. Studies assessing the prevalence of asthma diagnosis and of its sub-groups with more accurate methods are therefore needed This study aims to determine the prevalence of asthma, difficult-to-treat and severe asthma in Portugal, and to characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.
We will conduct a population-based nationwide study with a multicentre stepwise approach, enrolling 7500 adult subjects, randomly selected, from the Portuguese National Health Service patients' database of 38 primary care centres:
STAGE 0 - Phone call invitation and enrolment of participants STAGE 1 - Telephone interview survey to assess respiratory symptoms. STAGE 2 - Clinical assessment, diagnostic confirmation, and patient characterization STAGE 3 - Characterization of asthma patients (sub-group) and characterization of difficult- to-treat asthma & severe asthma patients after 3 months follow up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults =>18 years old registered in Portuguese National Health service patients' database of primary care units.
- •Give voluntary signed informed consent,
- •Ability to understand ans answer questionnaires.
排除标准
- •Participants that have a physical condition that could interfere with the study assessments or prevent the participant from adequately participating in the study (e.g. mobility problems, not able to perform spirometry,...)
结局指标
主要结局
Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma
时间窗: From date of inclusion until the end of the study currently planned (2,5 years)
Ratio between the total number of participants with confirmed asthma, difficult-to-treat asthma, and severe asthma and the total number of participants
次要结局
- Subject's characteristics - Living in a city or rural community(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Family history(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Age(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Physical activity(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Comorbidities and allergies(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Obesity(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Inflammatory biomarkers(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - occupational status(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Age of Asthma onset(From date of inclusion until the end of the study currently planned (2,5 years))
- Treatment Patterns - Treatment adherence(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Gender(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Marital status(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Smoking status & environmental tobacco smoke(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Health related quality of life(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Healthcare resource use and costs(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - Referral(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Pulmonary function tests(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Disease control(From date of inclusion until the end of the study currently planned (2,5 years))
- Treatment Patterns - Inhalation technique(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Asthma symptoms(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Exacerbations(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Hospital admissions(From date of inclusion until the end of the study currently planned (2,5 years))
- Treatment Patterns - Treatment profile (current and last year)(From date of inclusion until the end of the study currently planned (2,5 years))
- Disease Characteristics - Emergency room (ER) visits(From date of inclusion until the end of the study currently planned (2,5 years))
- Subject's characteristics - socio-economic and education level(From date of inclusion until the end of the study currently planned (2,5 years))