PER-058-13已完成未知
A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF BENRALIZUMAB (MEDI-563) ADDED TO HIGH-DOSE INHALED CORTICOSTEROID PLUS LONG-ACTING β2 AGONIST IN PATIENTS WITH UNCONTROLLED ASTHMA (SIROCCO)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 96
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
- 12 至 75（—）
入选标准
- •Male and female patients aged from 18 to 75 years with diagnosed asthma, willing to provide informed consent and requiring continuous treatment with high-dose inhaled corticosteroids (>500 mcg fluticasone dry powder formulation equivalents total daily dose) and long-acting β2 agonists with or without additional maintenance asthma controller medications. Inclusion criteria detailed in page 24 of protocol in english, not enough space to include them all in this section.
排除标准
- •1.Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- •2.Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- •- Affect the safety of the patient throughout the study
- •- Influence the findings of the studies or their interpretations
- •- Impede the patient’s ability to complete the entire duration of study
- •3.Known history of allergy or reaction to the investigational product formulation
- •4.History of anaphylaxis to any biologic therapy
- •5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
- •Rest of exclusion criteria detailed in page 26 of protocol in english, not enough space to include them all in this section.
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