A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Moscow、俄罗斯联邦
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Saint Petersburg、俄罗斯联邦
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Alberta
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Calgary、Alberta、加拿大
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Ontario
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Ottawa、Ontario、加拿大
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Toronto、Ontario、加拿大
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Edeleny、匈牙利
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Matrahaza、匈牙利
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Tatabanya、匈牙利
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Torokbalint、匈牙利
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Zalaegerszeg - Pozva、匈牙利
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Bucheon-si、大韩民国
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Seoul、大韩民国
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Suwon、大韩民国
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Feldbach、奥地利
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Hallein、奥地利
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Wien、奥地利
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Bruxelles、比利时
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Leuven、比利时
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Liege、比利时
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Bialystok、波兰
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Chodziez、波兰
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Gdansk、波兰
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Wroclaw、波兰
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California
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Encinitas、California、美国
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Huntington Beach、California、美国
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Los Angeles、California、美国
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San Diego、California、美国
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Stockton、California、美国
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Colorado
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Colorado Springs、Colorado、美国
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Georgia
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Stockbridge、Georgia、美国
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Maryland
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Baltimore、Maryland、美国
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Massachusetts
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North Dartmouth、Massachusetts、美国
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Missouri
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Saint Louis、Missouri、美国
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Montana
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Bozeman、Montana、美国
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Nebraska
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Bellevue、Nebraska、美国
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New Jersey
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Skillman、New Jersey、美国
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New York
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Rockville Centre、New York、美国
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North Carolina
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High Point、North Carolina、美国
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Ohio
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Cincinnati、Ohio、美国
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Oregon
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Lake Oswego、Oregon、美国
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Medford、Oregon、美国
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Pennsylvania
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Pittsburgh、Pennsylvania、美国
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Texas
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Dallas、Texas、美国
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El Paso、Texas、美国
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Wisconsin
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Madison、Wisconsin、美国
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Helsinki、芬兰
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Jyväskylä、芬兰
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Turku、芬兰
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Rotterdam、荷兰
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men or women 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 powder or equivalent
- Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points
Exclusion Criteria:
- Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
- History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Placebo
Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
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SC注射。
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实验性的：AMG 827 140 mg
Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
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SC injection.
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实验性的：AMG 827 210 mg
Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
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SC injection.
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实验性的：AMG 827 280 mg
Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
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SC injection.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Scores to Week 12
大体时间：Baseline and Week 12
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The ACQ is an instrument used in clinical research and practice to evaluate asthma control/impairment. It is a validated composite score that assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon awakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and forced expiratory volume in 1 second (FEV1). The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/limitation) scale. The total score is obtained by adding the value from each question and dividing by the number of questions. Higher scores indicates worsening of condition and a negative change from baseline indicates improvement. |
Baseline and Week 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change From Baseline in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
大体时间：Baseline and Week 12
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FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
FEV1 was performed both pre and post-administration of bronchodilator treatment at Baseline and Week 12.
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Baseline and Week 12
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Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) to Week 12
大体时间：Baseline and Week 12
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Baseline and Week 12
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Change From Baseline in the Frequency of Rescue Short Acting β-Agonist (SABA) Use to Week 12
大体时间：Baseline to Week 12
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Participants recorded SABA use for 1 week prior to randomization (baseline) and the average number of days recorded was subtracted from average days of SABA use across 12 week intervention period.
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Baseline to Week 12
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Change From Baseline in Daily Asthma Symptom Score to Week 12
大体时间：Baseline and Week 12
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Participants recorded their daily asthma symptoms in their electronic diaries (Ediary). It included 7 questions: frequency of night time awakening, time awake at night, wheezing, shortness of breath, cough, chest tightness and activity limitation. Daily asthma symptoms score is the sum of 7 individual scores (with the total score ranging from 0-21). Higher scores indicates worsening of condition and a negative change from baseline indicates improvement. |
Baseline and Week 12
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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12
大体时间：Baseline and Week 12
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The AQLQ is the most commonly used asthma specific instrument and includes evaluations of both symptom and quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms (Mitchell EA et al, 1997, Juniper et al, 1994, Christie MJ et al, 1993, Juniper et al, 1993). Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score = mean of the responses to the 32 questions. Higher scores indicate "better quality of life" and a positive change from baseline indicates improved symptoms. |
Baseline and Week 12
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Proportion of Asthma Symptom-free Days
大体时间：Up to Week 12
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Asthma symptom-free days were defined as a participant having a score of zero in their daily asthma symptom score. Asthma symptom-free days without SABA use were defined as a participant having a score of zero in their daily asthma symptom score and no SABA use. The proportion of asthma symptom-free days was calculated as the number of asthma symptom-free days over the number of days in the double-blind treatment period (12 weeks). |
Up to Week 12
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Time to Maximum Observed Concentration (Tmax) of AMG 827 at Week 8 to 10
大体时间：Week 8 (days 60 and 64), and pre-dose on Week 10
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Week 8 (days 60 and 64), and pre-dose on Week 10
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Maximum Observed Concentration (Cmax) of AMG 827 at Week 8 to 10
大体时间：Week 8 (days 60 and 64), and pre-dose on Week 10
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Week 8 (days 60 and 64), and pre-dose on Week 10
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Area Under the Concentration-time Curve During the Dosing Interval (AUCtau) of AMG 827 at Week 8 to 10
大体时间：Week 8 (days 60 and 64), and pre-dose on Week 10
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Week 8 (days 60 and 64), and pre-dose on Week 10
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合作者和调查者
赞助
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.