Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Delivered Dose of Fluticasone (on the Filter)
研究概览
简要总结
The primary objective of this study is to determine ex vivo the amount of fluticasone deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated actuation/inhalation maneuver.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Asthmatic children between the ages of 5 and 8 followed at Arkansas Children's Hospital.
- •The subjects must be available to complete the study.
- •The subject's parent(s) and/or the subject's legal guardian must provide written informed consent to participate in the study.
- •The subject must provide assent when older than 7 years old.
- •The subjects should have used a pMDI VHC previously and be able to use a VHC with mouthpiece.
- •The subjects should have been prescribed fluticasone or another inhaled corticosteroid delivered via a pMDI VHC combination.
- •Clinically stable asthma.
- •Cooperative, i.e., subject should be able to follow and understand instructions.
- •The subject must satisfy the study investigator about his/her fitness to participate in the study.
排除标准
- •Clinically significant respiratory disease in the previous 4 weeks.
- •Participation in any other clinical trial in the previous 4 weeks.
- •Lack of cooperation, subject cannot follow and understand instructions.
结局指标
主要结局
Delivered Dose of Fluticasone (on the Filter)
时间窗: Day 1
This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers
时间窗: Day 1
This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.
次要结局
- Inspiratory Tidal Volume(Day 1)
- Inspiratory Peak Flow(Day 1)