NCT01385696已完成3 期
Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
研究概览
简要总结
Preference study: Genuair vs HandiHaler inhalers in COPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •Adult male or female patients aged ≥ 40 with stable COPD
- •Naïve patients to the use of study inhalers
- •Patients agreeing on participating and signing the Informed Consent Form
排除标准
- •Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
- •Patients unable to read product package instructions and answer patient reported questionnaires
研究组 & 干预措施
group B
Experimental
HandiHaler first, Genuair second
干预措施: Genuair® (Almirall S.A.) (Device)
group B
Experimental
HandiHaler first, Genuair second
干预措施: HandiHaler® (Boehringer Ingelheim's) (Device)
group A
Experimental
Genuair first, HandiHaler second
干预措施: Genuair® (Almirall S.A.) (Device)
group A
Experimental
Genuair first, HandiHaler second
干预措施: HandiHaler® (Boehringer Ingelheim's) (Device)
结局指标
主要结局
Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2
时间窗: 14 days
Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)
次要结局
- Mean Overall Satisfaction With Genuair and Handihaler at Visit 2(14 days)
- Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2(14 days)
研究者
研究点 (4)
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