NCT06731959尚未招募2 期
A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER-01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
Aer Therapeutics0 个研究点目标入组 100 人开始时间: 2024年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- FEV1
研究概览
简要总结
AER-01-002 is a Phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe COPD.
Study will compare active drug to placebo.
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)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fexlamose
Experimental
Fexlamose solution once daily via nebulizer for 28 days
干预措施: Flexlamose (Drug)
Placebo
Placebo Comparator
Placebo solution once daily via nebulizer for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
FEV1
时间窗: 4 weeks
Change from baseline in prebronchodilator FEV1 at Week 4
次要结局
- Incidence of AEs (including SAEs and AESIs) throughout the study(4 weeks)
- Change from baseline in CT mucus plug segment score at Week 4(4 weeks)
- Change from baseline in E-RS:COPD score at Week 4(4 weeks)
- Change from baseline in prebronchodilator FVC at Week 4(4 weeks)
- Change from baseline in SpO2 at Week 4(4 weeks)
研究者
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