Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.
研究概览
简要总结
The aim of this study is to describe patient preferences on budesonide/formoterol fix dose combination for the treatment of their COPD, and to find those factors more strongly associated to a better attitude to medication.
详细描述
Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of subject informed consent and to be an outpatient
- •Clinical diagnosis of COPD according to ICD-10 classification, females and males, aged ≥ 40 years
- •To be prescribed a fixed dose combination of inhaled budesonide/formoterol fix combination at least 3 months before the study start
排除标准
- •Pregnancy for women
- •Use of inhaled medication via a metered dose inhaler (pMDI)
- •Currently participating in randomized clinical trials and being included in this study once
结局指标
主要结局
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population.
时间窗: During 1 month, up to September 2012
The FSI-10 is a self-completed 10-item questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled medications. Each of the 10 items has 5 response options from poorer to greater ease of use, scored 1 to 5, respectively. The minimum score is 10 whereas the maximum is 50.
次要结局
- Socio-demographics profile(During 1 month, up to September 2012)
- Clinical characteristics(During 1 month, up to September 2012)
- Treatment-related information(During 1 month, up to September 2012)
- Inhaler use(During 1 month, up to September 2012)
- Site characteristics(During 1 month, up to September 2012)