EUCTR2020-003014-12-DK进行中（未招募）1 期
COPD - Eosinophil-guided Reduction of Inhaled COrticoSteroids (COPERnICOS) - COPERNICOS
Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)0 个研究点目标入组 444 人开始时间: 2020年7月9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
- 444
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
- •COPD (verified by a specialist in respiratory medicine + spirometry).
- •GOLD risk class C/D anytime within the last 2 years (corresponding to 2 = AECOPD and/or =1 AECOPD leading to hospitalization during a 12 months period within the last 2 years) and/or FEV1<30%.
- •Must receive at least during last 4 weeks: LAMA, LABA and ICS.
- •Informed consent.
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •Known asthma
- •Male <40 years
- •Female <40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test
- •Severe mental illness which considerably complicates co-operation.
- •Language problems that considerably complicate co-operation.
- •Current treatment with systemic corticosteroids corresponding to > 5 mg prednisolone per day.
- •Systemic antibiotic treatment or systemic corticosteroid treatment within 14 days (also prophylactic Azithromycin).
- •Contra-indication to treat with Azithromycin (as listed by the producer).
- •Non-bacterial exacerbation per investigator judgement in the last 3 months.
研究者
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