A Randomized, Double-blind, Double-dummy, Active-controlled, 3-period Complete Cross-over Study to Assess the Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period
研究概览
简要总结
The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.
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
- 18 Years 至 75 Years（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
Sequence 5
C-A-B
干预措施: QVM149 150/50/160 μg o.d. (Drug)
Sequence 5
C-A-B
干预措施: salmeterol/fluticasone FDC 50/500 μg b.i.d. (Drug)
Sequence 5
C-A-B
干预措施: QVM149 150/50/80 μg o.d. (Drug)
Sequence 1
A-B-C
干预措施: QVM149 150/50/80 μg o.d. (Drug)
Sequence 1
A-B-C
干预措施: QVM149 150/50/160 μg o.d. (Drug)
Sequence 1
A-B-C
干预措施: salmeterol/fluticasone FDC 50/500 μg b.i.d. (Drug)
Sequence 2
A-C-B
干预措施: QVM149 150/50/80 μg o.d. (Drug)
Sequence 2
A-C-B
干预措施: QVM149 150/50/160 μg o.d. (Drug)
Sequence 2
A-C-B
干预措施: salmeterol/fluticasone FDC 50/500 μg b.i.d. (Drug)
Sequence 3
B-C-A
干预措施: QVM149 150/50/80 μg o.d. (Drug)
Sequence 3
B-C-A
干预措施: QVM149 150/50/160 μg o.d. (Drug)
Sequence 3
B-C-A
干预措施: salmeterol/fluticasone FDC 50/500 μg b.i.d. (Drug)
Sequence 4
B-A-C
干预措施: QVM149 150/50/80 μg o.d. (Drug)
Sequence 4
B-A-C
干预措施: QVM149 150/50/160 μg o.d. (Drug)
Sequence 4
B-A-C
干预措施: salmeterol/fluticasone FDC 50/500 μg b.i.d. (Drug)
Sequence 6
C-B-A
干预措施: QVM149 150/50/80 μg o.d. (Drug)
Sequence 6
C-B-A
干预措施: QVM149 150/50/160 μg o.d. (Drug)
Sequence 6
C-B-A
干预措施: salmeterol/fluticasone FDC 50/500 μg b.i.d. (Drug)
结局指标
主要结局
Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period
时间窗: 3 weeks
The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma
次要结局
- FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose(-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks)
- FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose(-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks)
- FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose(-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks)
- FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)(3 weeks)
- Trough FEV1 After 21 Days of Treatment(3 weeks)