A Randomized, Open Label Comparative Study to Determine the Proportion of Asthma Patients on SERETIDE Diskus 50/250 mcg b.i.d. Achieving Total Control When Given Medication and Compliance Enhancement Training Compared to Those Receiving Medication Only
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- number of subjects who achieved Total asthma Control: Period 2
研究概览
简要总结
This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Interventional group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2
干预措施: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training (Drug)
Control group: Period 2
Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2
干预措施: salmeterol/fluticasone propionate 50/250 µg (Drug)
Subjects receiving salmeterol/fluticasone propionate: Period 1
All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1
干预措施: salmeterol/fluticasone propionate 50/250 µg (Drug)
结局指标
主要结局
number of subjects who achieved Total asthma Control: Period 2
时间窗: Up to Week 24
Proportion of subjects who achieved Total Control in 7 out of the last 8 consecutive weeks in treatment period 2 with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing and compliance enhancement training compared with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing without compliance enhancement training.
次要结局
- Time to first individual week with Total Control(Up to Week 24)
- Morning peak expiratory flow (PEF)(Up to Week 24)
- Forced expiratory volume in one second (FEV1)(Up to Week 24)
- Asthma symptom score(Up to Week 24)
- Number of subjects using rescue medication(Up to Week 24)
- Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2(Up to Week 12)
- Number of nights with awakening due to asthma(Up to Week 24)
- Asthma severity score(Up to Week 24)
- Number of subjects with adverse events (AEs)(Up to Week 24)
- AQLQ score(Up to Week 24)