ISRCTN14181775进行中（未招募）2 期
Effects of blocking TSLP on airway inflammation and the epithelial immune response to exacerbation triggers in patients with COPD (UPSTREAM-COPD)
niversity of Leicester0 个研究点目标入组 80 人开始时间: 2024年2月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •1. Willing and able to consent to participate in the trial
- •2. Clinically diagnosed chronic obstructive airway disease with post bronchodilator FEV1 = 30% to 80% predicted value (and = 1.0L)
- •3. Age = 40 years old
- •4. Current or ex-smokers with = 10 pack years past smoking history
- •5. Stable airway disease status on maintenance inhaled therapy (LAMA+LABA±ICS) for at least 3 months prior to screening
- •6. History of =1 moderate to severe exacerbation event treated with prednisolone and/or antibiotic in the past 12 months
- •7. Good compliance with daily inhaler regime (= 70% adherence rate) at screening
排除标准
- •1. History of unstable or severe cardiac, hepatic, thyrotoxicosis, concomitant respiratory or renal disease, or other medically significant illness, which the investigator believes, would be a contraindication to study participation.
- •2. Significant concomitant respiratory disease such as cystic fibrosis, pulmonary fibrosis, aspergillosis, active or untreated primary tuberculosis.
- •3. Any significant abnormal laboratory results at screening, which in the opinion of the investigator, may put the subject at risk to take part in the study,
- •4. Current diagnosis of Asthma
- •5. Previous Lung volume reduction surgery for the indication of COPD
- •6. Any use of home oxygen therapy
- •7. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
- •8. Recent acute exacerbation event requiring oral corticosteroids or antibiotics (any dose for more than 3 days) or respiratory tract infection 4 weeks prior to screening
- •9. History of active Malignancy in any organ system (diagnosis within last 12 months or ongoing active cancer treatment such as chemotherapy, radiotherapy, or immunotherapy.
- •10. History of treatment with biologics within four months or five half-lives (whichever is longer) prior to screening.
- •11. History of anaphylaxis to any biologic therapy or sensitivity of any component of IMP formulation
- •12. Have been involved in another medicinal trial (CTIMP) within the past 28 days
- •13. Women who are pregnant, lactating or intend to become pregnant during the study period
- •14. Planned surgical procedures requiring general anaesthesia or in-patient status for > 1 day during the conduct of the study.
- •15. Receipt of any live or attenuated vaccines within 15 days prior to screening
- •16. Patients whose treatment is considered palliative (life expectancy < 6 months).
- •17. History of chronic alcohol or drug abuse within 12 months prior to screening
- •18. Receipt of immunoglobulin or blood products within 30 days prior to screening
- •19. Use of immunosuppressive medication (e.g., methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid) within 3 months prior to screening.
- •20. History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency.
- •21. Subject taking antiretroviral medications, as determined by medical history
- •22. History of human immunodeficiency virus (HIV) or hepatitis B or C.
研究者
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