NCT01302587已完成不适用
A Prospective, Open Label, Assessment of [an Albuterol] Hydrofluoroalkane (HFA) Metered Dose Inhaler MDI Integrated Dose Counter
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 21
- 主要终点
- The number of times the counter advanced but the inhaler did not actuate
研究概览
简要总结
This study is evaluating the effectiveness of a dose counter for an inhaler device used to deliver medication to people diagnosed with asthma or COPD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent/assent
- •General good health
- •Asthma or COPD
- •Capable of understanding the requirements, risks, and benefits of study participation.
- •Able to demonstrate proper metered-dose inhaler use and technique.
- •Other inclusion criteria apply
排除标准
- •History of life-threatening asthma or COPD that is defined for this protocol as an asthma or COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
- •Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of Screening Visit.
- •Is being treated with a long-acting β2-agonist alone.
- •Is currently being treated with Ventolin HFA.
- •Any asthma or COPD exacerbation requiring oral corticosteroids within 2 months of Screening Visit. A subject must not have had any hospitalization for asthma or COPD within 4 months prior to Screening Visit.
- •Historical or current evidence of a clinically significant non-asthmatic acute or chronic condition.
- •Uncontrolled hypertension
- •History of any adverse reaction to any component of the HFA-MDI formulation.
- •Participation in any investigational drug study within the 30 days preceding the Screening Visit.
- •Other exclusion criteria apply.
研究组 & 干预措施
Albuterol MDI
All participants in this study will receive an albuterol MDI inhaler.
干预措施: Albuterol (Drug)
结局指标
主要结局
The number of times the counter advanced but the inhaler did not actuate
时间窗: Days 1 through 46
MDI actuates but the counter display does not advance.
次要结局
- The number of times the inhaler actuated but the counter did not advance.(Days 1 through 46)
研究者
研究点 (21)
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