NL-OMON41749已完成3 期
Randomised, double-blind, chronic dosing (56 week) placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab (MEDI-563) in patients with moderate to very severe Chronic Ostructive Pulmonary Disease (COPD) with a history of COPD exacerbations (GALATHEA) - Galathea
Astra Zeneca0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- •1.Informed consent. ;2.Subjects 40-85 y.o. ;3.Moderate to very severe COPD with post-BD FEV1>20% and *65% . ;4.*2 moderate or *1 severe COPD exacerbation(s) required treatment or hospitalization within 2-52 weeks prior to Visit1. ;5.mMRC score *1 at Visit 1. ;6.Treatment with double or triple therapy throughout the year prior to Visit 1, constant 2 weeks prior to Visit 1. ;7.Tobacco history of *10 pack-years. ;8.Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1. ;9.Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first IP dose until 16 weeks after their last dose. ;10.Compliance with maintenance therapy during run-in *70% from visit 2 to visit 4.
排除标准
- •1. Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.;2. Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety*study findings or their interpretation or subject*s ability to complete the entire study duration.;3. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator*s judgment may put the patient at risk or negatively affect the study outcome.;4. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and screening/run-in period.;5. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1 or during the enrolment and screening/run-in period.;6. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and screening/run-in period.;7. Pregnant, breastfeeding, or lactating women.;8. Risk factors for pneumonia (including but not limited to: immunosuppression, neurological disorder with increased risk of aspiration).;9. History of anaphylaxis to any other biologic therapy. ;10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure. ;11. Use of immunosuppressive medication , including rectal corticosteroids and systemic steroids within 2 weeks prior to enrolment (visit1) and/or during the enrolment/screening/run-in period. ;12. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1. ;13. Subjects who in the opinion of the investigator or qualified designee have evidence of active
- •tuberculosis (TB). Subjects with a recent (within 2 years) first-time or newly positive
- •purified protein derivative (PPD) test or Quantiferon test need to complete an
- •appropriate course of treatment before being considered for enrolment.;14. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable). ;15. Asthma as a primary or main diagnosis according to the GINA guidelines or other accepted guidelines. ;16. Previous treatment with benralizumab.;17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
研究者
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