NL-OMON36320已完成3 期
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma. - Cephalon C38072/3081
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cephalon Inc
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- The patient is a male or female 12 through 75 years of age with a previous diagnosis of asthma.
- •- The patient has an ACQ score of at least 1.5.
- •- The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
- •- The patient is currently taking fluticasone at a dosage of at least 440 *g daily (or equivalent).
- •- The patient has a blood eosinophil count of at least 400/*L.
排除标准
- •- The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient*s safety.
- •- The patient has known HES.
- •- The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
- •- The patient is a current smoker.
- •- The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-*, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (randomization).
- •- The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
- •prior to screening.
- •- The patient has previously received anti-hIL-5 monoclonal antibody.
- •- The patient has a current infection or disease that may preclude assessment of asthma.
研究者
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