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临床试验/NCT01327001
NCT01327001已完成不适用

Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients in Real Life Condition in Czech Republic (UFO)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 2,815 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
2,815
试验地点
1
主要终点
Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year

研究概览

简要总结

Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic.

There is a hypothesis that doctors should prescribe to each patients per year: six units of fixed combination budesonide/formoterol, or seven units of fixed combination budesonide/formoterol in approach SMART, or twelve units of fixed combination salmeterol/fluticasone. With regard to current prices the treatment by fixed combination budesonide/formoterol should cost less.

The investigators do not have any data about real life utilization of fixed combination in asthma treatment in Czech Republic The investigators propose to conduct a non-interventional multicentric retrospective epidemiological study looking into the patients records kept by specialist - allergists and pulmologists.

Retrospective data for eligible patients will be reviewed by participating investigators, physicians taking care of their patients, and recorded in the electronic CRF. Only patients who have been treated for asthma bronchiale (classification of severity - moderate or severe persistent asthma) with fixed combination for at least one year could be included into the study. There are no scheduled visits for any patient participating in the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged 6 years or over
  • Asthma bronchiale, classification of severity - moderate or severe persistent
  • Documented fixed combination (budesonide/formoterol or salmeterol/fluticasone) therapy for at least 18 months

排除标准

  • 未提供

结局指标

主要结局

Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year

时间窗: 1 year

次要结局

  • Asthma severity in patients treated with fixed combination(1 year)
  • Strength/dose of prescribed fixed combination(1 year)

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

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