A Randomized, Parallel Group, Multicenter, Double -Blind, Double-dummy, Placebo-controlled Phase 3 Study With Beclomethasone Dipropionate HFA at 100 μg, 200 μg and 400 μg Daily Doses Compared to Placebo in Mild or Moderate Persistent Asthma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12
研究概览
简要总结
Approximately 480 (120 per group) would need to complete the 12 weeks of treatments.
详细描述
This is four arm study. Approximately 480 (120 per group) would need to complete the 12 weeks of treatments.In order to achieve that number of subjects, approximately 700 subjects will be screened randomized into the study.
A screening visit (Visit 1) will be followed by at least 2 weeks (14 days) placebo Run-in Period during which asthma subjects will wash out their daily inhaled corticosteroid and other medications and be assessed for compliance.
Study treatment period will be for a duration of 12 weeks with visits: Visit 2- Baseline Day 1, Visit 3 Day 21 (± 2 days), Visit 4 Day 42 (± 2 days), Visit 5 Day 63 (± 2 days), and Visit 6 Day 84 days (± 2 days).
Rescue Therapy: Short-acting beta agonists, Albuterol 90 μg/actuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double -blind, double-dummy
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, 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
400 µg per day Beclomethasone
Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 12 weeks
干预措施: 400 µg per day Beclomethasone (Drug)
200 µg per day Beclomethasone
Intervention: Drug: Beclomethasone 200 µg per day Daily dose of Beclomethasone 200 µg 1 inhalation 100 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
干预措施: Placebo (Drug)
200 µg per day Beclomethasone
Intervention: Drug: Beclomethasone 200 µg per day Daily dose of Beclomethasone 200 µg 1 inhalation 100 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
干预措施: 200 µg per day Beclomethasone (Drug)
100 µg per day Beclomethasone
Intervention: Drug: Beclomethasone 100 µg per day Daily dose of Beclomethasone 100 µg 1 inhalation 50 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
干预措施: Placebo (Drug)
100 µg per day Beclomethasone
Intervention: Drug: Beclomethasone 100 µg per day Daily dose of Beclomethasone 100 µg 1 inhalation 50 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
干预措施: 100 µg per day Beclomethasone (Drug)
placebo
Intervention: Drug: placebo 2 inhalations 2 times a day for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12
时间窗: 12 weeks
Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12
次要结局
未报告次要终点