A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo
研究概览
简要总结
The purpose of this study was to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in participants with mild to moderate COPD with CB.
详细描述
This was a multi-center, double-blind, placebo-controlled, randomized, Phase 2a study of ION-827359 in up to 180 participants. The participants were randomized to receive oral inhalation of either ION-827359 or placebo for up to 13 weeks. At the end of 13 weeks, participants entered a 10-week post-treatment evaluation period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 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
ION-827359 37.5 milligrams (mg)
Single-dose of ION-827359 37.5 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks.
干预措施: ION-827359 (Drug)
Placebo
Single-dose of placebo was administered by oral inhalation via nebulizer, once every week for up to 13 weeks.
干预措施: Placebo (Drug)
ION-827359 75 mg
Single-dose of ION-827359 75 mg was administered by oral inhalation via nebulizer, once every week for up to 13 weeks.
干预措施: ION-827359 (Drug)
结局指标
主要结局
Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo
时间窗: From Baseline up to average of Weeks 13 and 14
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Baseline was defined as the last non-missing measurement prior to the first study drug administration. The primary time point was defined as the average of weeks 13 and 14. FAS=Full analysis set.
次要结局
- Change From Baseline in the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Respiratory Symptoms (E-RS) Daily Symptom Diary Total Score to the Primary Time Point(From Baseline up to average of weeks 13 and 14)
- Change From Baseline in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) to the Week 14 Time Point(From Baseline to Week 14)
- Change From Baseline in St. George's Respiratory Questionnaire - COPD Specific (SGRQ-C) Total Score to the Week 14 Time Point(From Baseline to Week 14)
- Change From Baseline in Post-Bronchodilator FEV1(From Baseline to end of treatment (EOT) [Up to Week 14])
- Cmax: Maximum Observed Plasma Concentration for ION-827359(Days 1 and 85)
- Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359(Days 1 and 85)
- AUC[0-24h]: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours for ION-827359(Days 1 and 85)
- Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Based on Severity(Up to Week 24)
- Percentage of Participants With Clinically Significant Change in Laboratory Values(Up to Week 24)
- Percentage of Participants With Clinically Significant Change in Vital Sign Parameters(Up to Week 24)
- Percentage of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings(Up to Week 24)