A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Aera under curve FEV1 AUC 0-12h
研究概览
简要总结
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
详细描述
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)
- •Patients under Double
- •Patients under triple therapy (for 1 Mo prior Screening)
排除标准
- •Pregnant or lactating women
- •Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
- •concommitant diseases impacting feasibility or safety
研究组 & 干预措施
Glyco 25
BDP/FF (400/24 daily)+ Glyco 25µg daily
干预措施: Glycopyrrolate (Drug)
Glyco 50
BDP/FF (400/24 daily)+ Glyco 50 µg daily
干预措施: Glycopyrrolate (Drug)
Glyco 100
BDP/FF (400/24 daily)+ Glyco 100µg daily
干预措施: Glycopyrrolate (Drug)
BDP/FF 400/24
BDP/FF 400/24
干预措施: Comparator (Drug)
结局指标
主要结局
Aera under curve FEV1 AUC 0-12h
时间窗: day 1 and 7 of treatment period
次要结局
未报告次要终点