NCT01711086Unknown1 期
Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Guy Steuer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- FEV1
研究概览
简要总结
Double-blind study, randomized, controlled, and crossover. Study recruited 30 volunteers with stable asthma aged 8-18 years. Participants will perform lung function as part of the routine follow-up then will receive a Foradil 12mcg either with an Aerolizer (a standard dry powder inhaler) or with the Inspiromatic (an active, breath synchronized innovative inhaler). 3-60 days later participants will receive the same drug through the other inhaler.
Pre and post treatment (15 min, 30 min, 60 min) Lung function results, drug levels in the blood, vital signs and side effects will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 8-18 years with Asthma
- •50<FEV1<80
- •Can perform Spirometry
排除标准
- •Poor cooperation
- •Pregnancy
- •Milk Allergy
- •Other lung disease
- •Prior familiarity with Aerolizer
结局指标
主要结局
FEV1
时间窗: We will measure FEV1 post treatment (15 min, 30 min, 60 min)
Change in FEV1 from base line
次要结局
- Vital signs(Pre treatment and than 15 minutes post treatment)
研究者
研究点 (1)
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