NCT00436670已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 317 in Subjects With Moderate to Severe Asthma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 294
- 主要终点
- The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
研究概览
简要总结
A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 at the time of screening
- •Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening
- •At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical record within the past 12 months
- •Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent. Stable ICS dose for ≥ 30 days before screening and dose expected to remain stable during treatment with investigational agent. Must have used ICS for at least the last 3 consecutive months before screening
- •If receiving allergen immunotherapy, a stable dose for > 3 months before screening and anticipated to remain stable for the duration of the study
- •Positive to skin prick or RAST
- •Ongoing asthma symptoms with ACQ score at screening and baseline ≥ 1.5 points
- •Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10 years) who stopped ≥ 1 year ago
排除标准
- •Acute asthma exacerbation requiring emergency room (ER) treatment or hospitalization within 3 months
- •History of endotracheal intubation for asthma-related exacerbation within 3 years of screening
- •Respiratory illness within 4 weeks of screening
- •History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary condition other than asthma
- •Received long-acting beta agonist, theophylline, inhaled anticholinergics, oral beta 2 agonists, or cromolyn therapeutics within 1 week of first run-in visit.
- •Leukotriene antagonists within 2 weeks before first run-in visit
- •Oral or parenteral corticosteroids within 6 weeks before first run-in visit
- •Live/attenuated vaccinations within 4 weeks of screening or during the study
- •Any uncontrolled, clinically significant systemic disease (eg, chronic renal failure, uncontrolled hypertension, liver disease)
结局指标
主要结局
The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
时间窗: 12 weeks
次要结局
- Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)(12 weeks)
- Number of asthma symptom-free days(16 weeks)
- Change from baseline in daily asthma symptoms during week 12(12 weeks)
- Change from baseline in frequency of rescue beta agonist use during week 12(12 weeks)
- Change in AQLQ score at week 12 from baseline(12 weeks)
- Change in pre and post bronchodilator FEV1 at week 12 from baseline(12 weeks)
- Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs(16 weeks)
研究者
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