NCT01018550已完成2 期
A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 397
- 主要终点
- The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
研究概览
简要总结
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 to 65 years of age
- •Percent of predicted FEV1 ≥ 50% and ≤ 80%
- •At least 12% reversibility over pre-bronchodilator FEV1
- •Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
- •Ongoing asthma symptoms with ACQ score ≥ 1.5 points
排除标准
- •History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- •Any uncontrolled, clinically significant systemic disease
- •Respiratory infection within 4 weeks of the screening visit
研究组 & 干预措施
AMG 853
Experimental
干预措施: AMG 853 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.
时间窗: Baseline to Week 12
次要结局
- Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)(Baseline to Week 12)
- Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)(Baseline to Week 12)
- Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)(Baseline to Week 12)
- Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)(Baseline to Week 12)
- Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)(Baseline to Week 12)
研究者
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