EUCTR2018-000170-30-IT进行中（未招募）1 期
A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients with Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid plus Long acting B2 Agonist and Chronic Oral Corticosteroid Therapy (PONENTE) - PONENTE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Peripheral blood eosinophil count of =150 cells/µL assessed by central lab at Visit 1 or = 300 cells/µL in the past 12 months
- •2. History of physician diagnosed asthma requiring continuous treatment with high dose ICS (high-dose ICS budesonide/fomoterol HFA =
- •640/18 per day or equivalent , fluticasone propionate DPI > 500/day or equivalent, or authorized generics for these products ) plus LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers. The ICS can
- •also be given via nebulized solution for inhalation
- •3. Chronic oral corticosteroid therapy equivalent to a daily dose of at least 5 mg of prednisone, for at least 3 continuous months directly preceding Visit 1.
- •4. Patient should be on a stable OCS dose for at least 4 weeks prior to Visit 1.
- •5. Non-smokers, current smokers or former smokers with a smoking history of <20 pack-years at Visit 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 480
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts
- •2. Known history of allergy or reaction to the study drug formulation
- •3. History of anaphylaxis to any biologic therapy
- •4. 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
- •5. Asthma exacerbation requiring use of systemic corticosteroids, or an increase in maintenance dose of OCS, or acute upper/lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose)
- •6. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
- •7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =3 times the upper limit of normal (ULN) confirmed at Visit 1.
- •8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
- •9. Coincident primary adrenal failure (Addison’s disease) or irreversible secondary hypoadrenalism due to another independent cause (e.g. pituitary tumour or its treatment)
- •10. Co-existent inflammatory conditions for which chronic OCS doses are part of their maintenance treatment such as Giant Cell Arteritis, Polymyalgia Rheumatica
- •11. Exclusion from genetic research may be for any of the exclusion criteria specified in the main study or allogeneic bone marrow transplant, Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection
研究者
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