Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting-A Cross-sectional Study of Adult Asthma Patients in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,232
- 试验地点
- 57
- 主要终点
- The primary variable is status of asthma control in each patient
研究概览
简要总结
This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency, and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult asthma patients.
详细描述
Rationale for this Non-Interventional Study According to the Japanese Asthma Prevention and Management Guideline 2015 (Japan guideline (JGL) 2015), the goal in the management and treatment of asthma is "to be able to lead a life like a healthy individual." In order to achieve this therapeutic goal, the achievement of "well-controlled" state based on the asthma control status is considered to be a clinical goal. However, there are few studies in which the asthma control status is accurately surveyed in a real life setting in adult asthma patients receiving continued treatment from physician in Japan and the actual situation is unknown. By understanding the status of asthma control in asthma patients in a real life setting, the clinical issues could be clarified. Therefore, such information would contribute to appropriate treatment of asthma.
Thus, we planned this study to evaluate the asthma control status, asthma symptoms (severity, frequency, and limitations on activities, etc.), Quality of line (QOL), and use of drugs for asthma attack in the study population in a real life setting by recruiting patients through medical institutions providing continued care for asthma patients.
Objectives of this Non-Interventional Study
- Primary objective
To assess the proportion of adult asthma patients receiving continued treatment from physician in Japan in each asthma control status defined by JGL 2015 ("poorly-controlled," "insufficiently-controlled," and "well-controlled"). 2. Secondary objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided written consent before starting any procedure specified in the study protocol
- •Aged 20 years or older at the time of providing the consent
- •Receiving treatment for asthma as an outpatient at the time of providing the consent
- •Physician definitive diagnosis of asthma at least 1 year before providing the consent
- •Started to receive treatment with at least 1 of the following asthma drugs at least 1 year before providing the consent
排除标准
- •Enrolled in this study in the past
- •Assessed by the Investigator to require additional treatment due to worsening of asthma symptoms at the time of providing the consentEnrolled in this study in the past
- •Scheduled to be hospitalized within 2 weeks after providing the consent due to asthma or any other disease
- •Participating in another interventional study such as a clinical study at the time of providing the consent
- •Considered by the Investigator as not appropriate for enrollment in this study due to inability to adhere to the procedures, limitations, and requirements of this study including answering and returning the questionnaires, etc.
结局指标
主要结局
The primary variable is status of asthma control in each patient
时间窗: Day1 to Day7
Status of asthma control will be evaluated based on the patient diary and information in the clinical report form (CRF). Of the 6 items of Japanese guideline(JGL) 2015, the following 4 items will be used as indicators for evaluation of asthma control status: asthma symptoms (daytime and nighttime), use of a drug for asthma attack, limitation on activities including exercise, exacerbation (unscheduled visit, emergency room visit, and hospitalization). Status of asthma control in each patient ("well controlled," "insufficiently controlled," and "poorly-controlled" ) will be evaluated according to the evaluation criteria in JGL 2015.
次要结局
- Use of drugs for the treatment of asthma(Baseline)
- Asthma control status during the past 1 month(Baseline)
- Asthma control during the past 1 week(Baseline)
- QOL(Baseline)
- Use of drugs for asthma attack and emotional feelings(Baseline)
- Asthma symptoms(Baseline)