A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 981
- 试验地点
- 59
- 主要终点
- To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
研究概览
简要总结
The PRIME study is an observational, Real World Evidence study designed to collect the type of treatments that are currently prescribed to patients with mild asthma and to collect relevant clinical data that could reflect the control of the disease over a 6-month observational period according to the standard clinical practice.
详细描述
Outpatients attending the hospital clinics/study centres will be recruited. Patients with mild asthma treated by Step 1 or step 2 treatments according to GINA report will be recruited. A total of approximately 1200 patients will be enrolled. Patients will be followed-up during a 6-month observational period according to standard practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject (aged ≥ 18 years) up to 75 years
- •Subject with confirmed asthma diagnosis
- •Subject in treatment for mild asthma with Step 1 or Step 2 according to GINA report
- •Subject with written privacy and study informed consent
排除标准
- •Subject enrolled in experimental (interventional) clinical trials, or receiving experimental treatments in the prior 3 months
- •Known pregnant or breast-feeding subject
- •Subject unable to understand and autonomously fill in questionnaires
- •Subject unable to use electronic devices to fill in e-diary, or without compatible electronic devices with access to the Internet
- •Subject who had asthma exacerbation(s) in the past 4 weeks prior to study entry
- •Subject with confirmed Chronic Obstructive Pulmonary Disease
结局指标
主要结局
To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.
时间窗: 6-months period
Duration of asthma treatments (in months): * overall * by drug class (i.e., any switch to drugs within the same class will be considered as a continuation of the treatment) and by active substance (i.e., any dose adaptation will be considered as a continuation of the same drug). This will be adapted according to data availability.
次要结局
- To describe the prior asthma treatment of subjects with mild asthma at enrolment visit(At enrolment)
- To describe the clinical characteristics of subjects with mild asthma at enrolment visit(At enrolment)
- To describe the asthma exacerbations of subjects with mild asthma at enrolment visit(At enrolment)
- To describe subjects' level of asthma symptoms control by means of the Asthma Control Questionnaire (ACQ-5) during the 6-month observational period(At enrolment and at 6-month)
- To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period(At enrolment and at 6-month)
- To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period(At enrolment and at 6-month)
- To describe the occurrence of asthma exacerbations during the 6-month observational period(6-months period)
- To describe the subjects' quality of life by means of the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) during the 6-month observational period(At enrolment and at 6-month)
- To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit(At enrolment)
- To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit(At enrolment)
- To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period(At enrolment and at 6-month)
- To describe the occurrence of adverse drug reactions (ADRs) in subjects with mild asthma during the 6-month observational period.(6-month)
- To describe the Socio-demographics data of subjects with mild asthma at enrolment visit(At enrolment)
- To describe subjects' level of asthma symptoms control by means of the Asthma Control Test (ACT) during the 6-month observational period(At enrolment and at 6-month)
- To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period(6-months period)
- To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period(At enrolment and at 6-month)
- To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period(At enrolment and at 6-month)