NCT00587288已完成2 期
An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation
Ception Therapeutics60 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 60
- 主要终点
- Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.
详细描述
Objectives:
Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.
Secondary:
- To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
- To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
- To assess the safety and tolerability of reslizumab in subjects with asthma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •male or female subjects aged ≥ 18 to 75 years at time of screening
- •female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
- •confirmation of asthma
- •symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
- •requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
- •requirement for >/= 3% eosinophils in induced sputum at Screening
排除标准
- •a clinically important event that would interfere with study schedule or procedure or compromise subject safety
- •a diagnosis of hypereosinophilic syndrome
- •an underlying lung disorder
- •a current smoker
- •use of systemic immunosuppressive agents within 6 months of study
- •current use of systemic corticosteroids
- •received attenuated live attenuated vaccines within three months prior to study entry
- •expected to be poorly compliant with study drug, procedures, visits
- •aggravating factors that are inadequately controlled
- •participation in any investigational drug or device study within 30 days prior to study entry
- •participation in biologics study within 3 months prior to study entry
- •receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
- •female subjects who are pregnant or nursing
- •concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
- •concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency).
- •current suspected drug and/or alcohol abuse
结局指标
主要结局
Mean Change From Baseline to End of Therapy in Asthma Control Questionnaire (ACQ) Score
时间窗: Baseline through End of Therapy (up to 15 weeks)
The ACQ is a 7 question instrument. Each question has 7 possible answers of 0, 1, 2, 3, 4, 5, and 6. Each increasing value is an indication of poorer asthma control. At protocol specified visits, the participant answered questions 1 to 6, circling the response that best described how that participant was during the past week, on the basis of a daily diary for the week before the visit. At the actual visit, study center personnel reviewed the questions and responses with the participant and determined the response and score for question 7. The overall ACQ score was presented as the mean of these 7 individual scores and was a number between 0 and 6, but not necessarily an integer.
次要结局
- Change From Baseline to End of Therapy in Percent Predicted FEV1(Baseline, End of Therapy (up to 15 weeks))
- Mean Change From Baseline to End of Therapy in Induced Sputum Eosinophil Levels(End of Screening or Baseline, End of Therapy (up to 15 weeks))
- Percentage of Participants With Clinical Asthma Exacerbations (CAEs)(up to 15 weeks)
- Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation(From start of study drug through 15 weeks + 30 days)
- Change From Baseline to End of Therapy in Forced Expiratory Volume in the First Second (FEV1)(Baseline, End of Therapy (up to 15 weeks))
- Percentage of ACQ Responders at End of Therapy(Baseline, End of Therapy (up to 15 weeks))
研究者
研究点 (60)
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