An International Multi-centre Prospective Cohort Study in Patients Hospitalized for an Acute Exacerbation of COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Wim Janssens
- 入组人数
- 1,000
- 试验地点
- 30
- 主要终点
- All-cause mortality
研究概览
简要总结
The CATALINA study is a prospective cohort study embedded within CICERO (Collaboration In COPD ExaceRbatiOns, a European Respiratory Society supported Clinical Research Collaboration), designed to collect standardised, longitudinal clinical data and biological samples in 20 centres across Europe and beyond.
详细描述
The initial objective is to recruit 1000 patients hospitalised for an acute COPD exacerbation by the end of CICERO's first lifecycle (3 years), from whom 1 year follow-up data and biological samples will be collected. By doing so, CICERO aims to develop a comprehensive European COPD patient data- and biobank phenotyped in relation to the exacerbation, to support the development of future EU-wide clinical intervention trials in COPD for specific patient subgroups, as well as new prognostication tools for COPD exacerbations.
The clinical data and biological samples will be obtained during 6 scheduled study visits, during the hospitalization period of the index acute exacerbation as well as the outpatient setting after hospital discharge; and 3 additional unscheduled study visits should the patient be readmitted for respiratory reasons during study participation (i.e. first readmission only).
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3 study visits will be scheduled during the hospitalization period of the index acute exacerbation:
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visit 1: within 48h of hospital admission, study inclusion (Day 1)
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visit 2: at 72h after study inclusion (Day 3)
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visit 3: at hospital discharge, at investigator's discretion (Day X)
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3 study visits will be scheduled during the outpatient setting:
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visit 4: at 3 months after study inclusion (Day 90)
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visit 5: at 6 months after study inclusion (Day 180)
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visit 6: at 12 months after study inclusion (Day 365)
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The first hospital readmission for respiratory reasons during the patient's study participation will undergo the same testing schedule as mandated during the hospitalization period of the index event:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test with an FEV1/FVC < 0.7)
- •Current hospitalization with suspicion of an acute exacerbation of COPD (AECOPD)
- •Inclusion within 48 hours post hospital admission
- •Voluntary written informed consent of the participant or his/her representative obtained prior to any study procedure
排除标准
- •Patients unwilling or unable to comply with study procedures
- •Patients not requiring treatment with systemic corticosteroids, antibiotics or both as a minimum therapy for the index AECOPD
- •Patients with a confirmed positive test result for COVID19, or those highly suspected based on clinical examination
结局指标
主要结局
All-cause mortality
时间窗: Will be assessed during 1 year, on visits 2-6
Death from any cause
次要结局
- Severe treatment failure(Will be assessed during 1 year, on visits 2-6)
- Readmission for a severe COPD exacerbation(Will be assessed during 1 year, on visits 2-6)
- Change in Generalized Anxiety Disorder-7 (GAD-7): an anxiety scale(Will be assessed during 1 year, on visits 2-6)
- Treatment intensification for respiratory reasons(Will be assessed during 1 year, on visits 2-6)
- New hospitalization for respiratory reasons(Will be assessed during 1 year, on visits 2-6)
- Total days in hospital(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker IL-33(Will be assessed during 1 year, on visits 2-6)
- Treatment failure(Will be assessed during 1 year, on visits 2-6)
- Hospital care intensification for respiratory reasons(Will be assessed during 1 year, on visits 2-6)
- Number of participants with a new or changed Do Not Resuscitate (DNR) code(Will be assessed during 1 year, on visits 2-6)
- Cumulative dose of systemic corticosteroids(Will be assessed during 1 year, on visits 2-6)
- Change in modified Medical Research Council (mMRC): a dyspnea scale(Will be assessed during 1 year, on visits 2-6)
- Step-up in hospital care for respiratory reasons(Will be assessed during 1 year, on visits 2-6)
- Time to(Will be assessed during 1 year, on visits 2-6)
- Change in COPD Assessment Test (CAT): a COPD impact scale(Will be assessed during 1 year, on visits 2-6)
- Change in Patient Health Questionnaire-9 (PHQ-9): a depression scale(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker IL-8(Will be assessed during 1 year, on visits 2-6)
- Change in comorbidities(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker IL-5(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker MCP-4 (CCL13)(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker TARC4 (CCL17)(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker IP-10 (CXCL10)(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker IL1A(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker Eotaxin-3 (CCL26)(Will be assessed during 1 year, on visits 2-6)
- Change in biomarker GM-CSF(Will be assessed during 1 year, on visits 2-6)
- Change in patient reported experience measure (PREM)(Will be assessed during 1 year, on visits 2-6)