EUCTR2022-000179-38-DK进行中（未招募）1 期
Effects of blocking TSLP on airway inflammation and the epithelial immune-response to exacerbation triggers in patients with COPDA randomized double-blind, placebo-controlled trial of tezepelumab - UPSTREAM-COPD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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.Written informed consent
- •2.A diagnosis of COPD
- •3.= 10 packyears smoked (current or ex-smokers)
- •4.Age 40 years or older
- •5.Postbronchodilator FEV1 = 30% predicted (and = 1.0L) and < 80% predicted
- •6.Maintenance treatment with LAMA+LABA±ICS (stable dose) for at least 3 months prior to V1
- •7.=1 prednisolon and/or antibiotic treated exacerbation in the past 12 months
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject’s ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.
- •2.Any concomitant respiratory disease that in the opinion of the investigator will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis, pulmonary fibrosis, aspergillosis, active tuberculosis).
- •3.Current asthma
- •4.Lung volume reduction surgery for COPD
- •5.Exacerbation requiring oral corticosteroids or antibiotics (any dose for more than 3 days) 4 weeks prior to Visit 1 or during the run-in period
- •6.Any use of home oxygen therapy
- •7.Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study
- •8.History of cancer:
- •Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1.
- •Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
- •9.Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 4 weeks prior to Visit 1 or during the screening period
研究者
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