A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Change from baseline in FEV1 percent predicted compared to placebo
研究概览
简要总结
Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
详细描述
This is four arm study. Approximately 480 (120 per group) would need to complete the 6 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 inclusive of at least the 2-week (14 days) placebo Run-in Period during which asthma subjects will wash out their daily inhaled corticosteroid and other medications and assessed for compliance. Study treatment period will be for a duration of 6 weeks with visits: Visit 2 - Baseline Day 1; Visit 3 Day 21 (± 2 days) and Visit 4 Day 42 (± 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 design for the test product and placebo for primary endpoint analysis. Evaluator blinded reference product
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
Beclomethasone 800 µg per day
Intervention: Drug: Beclomethasone 800 ug per day Daily dose of Beclomethasone 800 ug 4 inhalations 100 μg ex-valve 2 times a day for 6 weeks
干预措施: Beclomethasone 800 µg per day (Drug)
Beclomethasone 640 µg per day
Intervention: Drug: Beclomethasone 640 µg per day 4 inhalations 80 μg ex-actuator 2 times a day for 6 weeks
干预措施: Beclomethasone 640 µg per day (Drug)
Placebo
Intervention: Drug: placebo 4 inhalations 2 times a day for 6 weeks
干预措施: Placebo (Drug)
Beclomethasone 400 µg per day
Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 6 weeks Intervention: Drug: Placebo 2 inhalations 2 times a day for 6 weeks
干预措施: Placebo (Drug)
Beclomethasone 400 µg per day
Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 6 weeks Intervention: Drug: Placebo 2 inhalations 2 times a day for 6 weeks
干预措施: Beclomethasone 400 µg per day (Drug)
结局指标
主要结局
Change from baseline in FEV1 percent predicted compared to placebo
时间窗: 6 weeks
The primary analysis of change from baseline trough (pre-dose and pre-rescue bronchodilator) FEV1 percent predicted (0-6 weeks) will be carried out on the mITT Population using analysis of covariance (ANCOVA) with treatment as an effect, and status of previous steroid use (naïve or prior use) as the covariate. The efficacy endpoint for the primary analysis is the change from baseline trough FEV1%- predicted at week 6.
次要结局
- AUC at week in FEV1 compared to placebo(6 weeks)