Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
研究概览
简要总结
Delivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Physician diagnosis of asthma.
- •FEV1 60-80% predicted during the day.
- •FEV1 increases ≥ 12 % and to ≥ 80% predicted after 2- 4 puffs of albuterol HFA MDI delivered by antistatic VHC.
- •No smoking in the previous year and < 10-pack year history.
- •No history of severe asthma attacks requiring ER visit or hospitalization in the previous three months.
排除标准
- •Patient required a short course of oral steroid in the past 30 days.
- •Any disease that is inadequately controlled or any medication that would worsen asthma or interact with asthma medications.
- •History of viral respiratory tract infection in the 3 weeks prior to the screening visit.
- •Positive pregnancy test.
研究组 & 干预措施
Anti-static then Static for Albuterol
albuterol anti-static first then static chamber second.
干预措施: anti-static then static (Device)
Static then Anti-static for Albuterol
static then antistatic albuterol
干预措施: Static then anti-static chamber (Device)
结局指标
主要结局
Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
时间窗: fifteen minutes after 1 puff of albuterol
(Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber
Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
时间窗: 15 minutes after 2 puffs of albuterol
(Percent improvement in FEV1(Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber
Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
时间窗: fifteen minutes after 4 puffs of albuterol
(Percent improvement in FEV1 (Forced Expiratory Volume and Forced Vital Capacity) Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber
次要结局
未报告次要终点