NCT00830102已完成2 期
A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma
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
- 64
- 试验地点
- 1
- 主要终点
- Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline
研究概览
简要总结
The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.
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
- Double (Participant, Investigator)
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
- •Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid
排除标准
- •Smoking history within the last 12 months
- •No history of respiratory tract infection within 4 weeks
- •No history or evidence of any clinically significant disease or abnormality
研究组 & 干预措施
1
Active Comparator
- Period 1 Treatment Regimen A: FlutiForm 100/10 ug
- Period 2 Treatment Regimen B: FlutiForm 250/10 ug
- Period 3 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
- Period 4 Treatment Regimen D: Flixotide Evohaler 250 ug
干预措施: fluticasone propionate, formoterol fumarate (Drug)
2
Active Comparator
- Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug
- Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
- Period 3 Treatment Regimen B: FlutiForm 250/10 ug
- Period 4 Treatment Regimen A: FlutiForm 100/10 ug
干预措施: fluticasone propionate, formoterol fumarate (Drug)
3
Active Comparator
- Period 1 Treatment Regimen B: FlutiForm 250/10 ug
- Period 2 Treatment Regimen A: FlutiForm 100/10 ug
- Period 3 Treatment Regimen F: Placebo
- Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug
干预措施: fluticasone propionate, formoterol fumarate (Drug)
4
Active Comparator
- Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug
- Period 2 Treatment Regimen F: Placebo
- Period 3 Treatment Regimen A: FlutiForm 100/10 ug
- Period 4 Treatment Regimen B: FlutiForm 250/10 ug
干预措施: fluticasone propionate, formoterol fumarate (Drug)
5
Active Comparator
- Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
- Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug
- Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug
- Period 4 Treatment Regimen F: Placebo
干预措施: fluticasone propionate, formoterol fumarate (Drug)
6
Active Comparator
- Period 1 Treatment Regimen F: Placebo
- Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug
- Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug
- Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug
干预措施: fluticasone propionate, formoterol fumarate (Drug)
结局指标
主要结局
Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline
时间窗: pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose
次要结局
- Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs(10 weeks including pre- and post-study assessments)
研究者
研究点 (1)
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