Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 174
- 试验地点
- 29
- 主要终点
- Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
研究概览
简要总结
The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.
This study will include a screening visit followed by a 4 month treatment period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental 1
Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
干预措施: Formoterol Fumarate in the Pressair DPI, Low Dose (Drug)
Experimental 2
Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
干预措施: Formoterol Fumarate in the Pressair DPI, High Dose (Drug)
Active Comparator 1
Foradil Aerolizer, Low Dose
干预措施: Foradil Aerolizer, Low Dose (Drug)
Active Comparator 2
Foradil Aerolizer, High Dose
干预措施: Foradil Aerolizer, High Dose (Drug)
Placebo
Dose matched placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
时间窗: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
次要结局
- Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)(Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment)