NCT00404261已完成4 期
An Open Label, Multicentre Study to Evaluate Patient Satisfaction With Fluticasone/Salmeterol HFA MDI With Counter in Adult Subjects (18 Years of Age and Older) With Asthma or COPD.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
研究概览
简要总结
The purpose of this study is to evaluate the level of satisfaction experienced by asthma or chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA MDI without counter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Outpatient
- •Documented physician diagnosis of asthma or COPD
- •Requires use of a controller and long acting beta 2 agonist
- •Ability to provided written informed consent
排除标准
- •Patients with life threatening asthma or COPD
- •Historical or current evidence of significant diseases
- •Immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the MDI formulation
- •History of drug or alcohol abuse Abnormal chest x ray not consistent with asthma or COPD
- •Use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than VENTOLIN HFA; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.
研究组 & 干预措施
Arm 1
Other
Fluticasone/Salmeterol HFA MDI without counter
干预措施: Fluticasone/Salmeterol HFA (Drug)
Arm 2
Other
Fluticasone/Salmeterol HFA MDI with counter
干预措施: Fluticasone/Salmeterol HFA (Drug)
结局指标
主要结局
Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).
时间窗: Day 30
次要结局
- Healthcare professional satisfaction questionnaires administered at baseline and at the end of treatment (day 30) Patient compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading.(Day 30)
- Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events(8 months)
研究者
研究点 (1)
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