NCT00512863撤回2 期
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel, Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
Abbott0 个研究点目标入组 272 人开始时间: 2007年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 272
- 主要终点
- The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.
研究概览
简要总结
To evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory 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
- Double
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
- •Documented history of refractory asthma, as defined by the American Thoracic Society,31 defined as 1 major and at least 2 minor criteria
- •Actual or documented history of reversible airway obstruction
- •Baseline FEV1 of 40% - 80% of the predicted for height, age, and sex at Screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
- •History of at least 1 asthma exacerbation leading to oral, IV or IM corticosteroid or ER/Urgent Care Center visit or hospitalization within the past year prior to Screening. This asthma exacerbation should not have been within 30 days prior to Screening
- •Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
- •Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication
排除标准
- •Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease [COPD], interstitial lung disease, pulmonary fibrosis) other than asthma
- •Current treatment for corticosteroid-resistant asthma (e.g., methotrexate [MTX], cyclosporine, gold salts, troleandomycin, immune globulin intravenous [IGIV], mycophenolate mofetil)
- •History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix.
- •History of listeria, human immunodeficiency virus (HIV), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB
- •Females who are pregnant or will not discontinue breast-feeding.
- •Subject with a history of clinically significant drug or alcohol abuse in the last year
- •Subjects with a poorly controlled medical condition.
- •Abnormal, clinically significant screening laboratory and other analyses (including ECG).
- •Subjects with any prior exposure to Tysabri® (natalizumab)
- •Prior treatment with any TNF antagonist, including adalimumab
结局指标
主要结局
The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.
时间窗: Week 16
次要结局
- Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period(Week 16)
- Change from Baseline in pre-bronchodilator FEV1
- Change from Baseline (pre-bronchodilator) in FEV1(30 minutes postbronchodilator)
- Change from Baseline in percent predicted FEV1
- Changes from Baseline in post-bronchodilator FEV1(Time points other thanWeek 16)
研究者
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