NCT00054964已完成2 期
Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
研究概览
简要总结
This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.
详细描述
This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening
- •Poor inhaler coordination as assessed at screening
- •Reversible bronchoconstriction (≥ 12% increase in FEV1)
排除标准
- •Albuterol allergy
- •Investigational drug within 30 days
- •Injected corticosteroid within 6 weeks
- •Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
- •Other criterial apply
研究组 & 干预措施
Albuterol HFA-BOI
Experimental
干预措施: Albuterol HFA-BOI (Drug)
Albuterol HFA-MDI
Active Comparator
干预措施: Albuterol HFA-MDI (Drug)
结局指标
主要结局
Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
时间窗: Pre-dose and +120 minutes
次要结局
- The maximum increase in SGaw from baseline over two hours(Baseline through +120 minutes)
- The area-under-the-effect curve of change in SGaw from basline over time(Pre-dose and +120 minutes)
- Time in hours to the maximum increase in SGaw from baseline(Baseline through +120 minutes post-dose)
研究者
研究点 (1)
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