EUCTR2018-003924-35-GB进行中（未招募）1 期
A Randomised Controlled Trial of Mepolizumab Initiated During Admission to Hospital for a Severe Exacerbation of Eosinophilic COPD - Mepolizumab for COPD Hospital Eosinophilic admissions Pragmatic trial1
niversity of Leicester0 个研究点目标入组 238 人开始时间: 2019年9月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 238
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. Symptoms typical of COPD when stable (baseline eMRC dyspnoea grade 2 or more).
- •2. A clinician defined exacerbation of COPD requiring admission to hospital.
- •3. Serum eosinophil count of = 300 cells/microlitre either at time of admission or at any one time in the preceding 12 months.
- •4. Smoking pack years > 10 years.
- •5. Age = 40 years.
- •6. Established on inhaled corticosteroids (ICS) prior to this admission.
- •7. Willing and able to consent to participate in trial.
- •8. Able to understand written and spoken English.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •1. COPD patients without eosinophilia (defined as persistently < 300 cells/microlitre within the last 12 months).
- •2. Other conditions that may be the cause of eosinophilia (such as hypereosinophilic syndrome, eosinophilic granulomatosis, eosinophilic oesophagitis or parasitic infection).
- •3. Patients whose treatment is considered palliative (life expectancy < 6 months).
- •4. Other respiratory conditions including active lung cancer, interstitial lung disease, primary pulmonary hypertension or any other conditions that in the view of the investigator will affect the trial.
- •5. Known history of anaphylaxis or hypersensitivity to mepolizumab or any of the excipients (sucrose, sodium phosphate dibasic heptahydrate, polysorbate 80).
- •6. Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina in the last 6 months, unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months and New York Heart Association (NYHA) Class IV heart failure.
- •7. Decompensated liver disease or cirrhosis.
- •8. Pregnant, breastfeeding, or lactating women. Women of child-bearing potential must agree to use appropriate methods of birth control and have a negative blood serum pregnancy test performed after randomisation but prior to dosing with randomised treatment.*
- •9. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives.
- •10. Known blood born infection (e.g. HIV, hepatitis B or C).
- •* Women of child bearing potential (WOCBP) – A woman is defined as being of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
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