Double Blind Placebo Controlled Trial Checking the Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol
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
研究组 & 干预措施
Aerolizer followed by Inspiromatic
volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Aerolizer dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Inspiromatic dry powder inhaler.
干预措施: Aerolizer Followed by Inspiromatic (Device)
Inspiromatic followed by Aerolizer
volunteers will perform lung function pre and post Formoterol (a bronchodilator) inhalation. They will use either the Inspiromatic dry powder inhalers the delivery device. 3-60 days later participants will receive the same drug through the Aerolizer dry powder inhaler.
干预措施: Inspiromatic followed by Aerolizer (Device)
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)