Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- asthma control based on GINA guidelines from 2007.
研究概览
简要总结
The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed.
详细描述
The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies. No therapy intervention is made with existing prescribed medications (SERETIDE or SYMBICORT), but evaluations outside standard care is made by evluations with diary cards, questionnaires, PEF evaluations and spirometry which is regarded as the intervention by the Swedish Authorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •18 years or above
- •able to fill in questionnaires and perform PEF measurements
- •asthma diagnosis and prescribed SERETIDE or SYMBICORT, either regular treatment using SERETIDE in a stable dosing and short acting B2 agonists as needed, or maintenance treatment with SYMBICORT but also using same inhaler SYMBICORT as needed
排除标准
- •no other lung disease
- •neurological disease with psychological handicap
- •cerebro-vascular disease with handicap
- •un-stable cancer
- •known or planned pregnancy during the time of the study
- •subjects who have serious uncontrolled disease
研究组 & 干预措施
Stable dosing with SERETIDE, short acting B-2agonist as needed
Regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed
干预措施: Spirometry, PEF measurements and diary cards to evaluate control of Asthma (Other)
Maintenance treatment with SYMBICORT and SYMBICORT as needed
Maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed
干预措施: Spirometry, PEF measurements and diary cards to evaluate control of Asthma (Other)
结局指标
主要结局
asthma control based on GINA guidelines from 2007.
时间窗: 3 months
次要结局
- Quality of Life, Health economics and exacerbations(3 months)