跳至主要内容
临床试验/NCT01711086
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

Guy Steuer1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年10月最近更新:
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

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

发起方
Guy Steuer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guy Steuer

Guy Steuer, M.D.

Rabin Medical Center

研究点 (1)

Loading locations...

相似试验