Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Respiratory Society | OTHER |
| AstraZeneca | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| GlaxoSmithKline |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
3 study visits will be scheduled during the hospitalization period of the index acute exacerbation:
3 study visits will be scheduled during the outpatient setting:
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:
Resulting from CICERO's future lifecycles will be the continued expansion of the data- and bio-bank, both in cohort size and duration of follow-up.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Death from any cause | Will be assessed during 1 year, on visits 2-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Step-up in hospital care for respiratory reasons | A composite outcome measure defined as:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with COPD, hospitalized for an acute exacerbation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Vermeersch, PhD | Contact | 016342284 | +32 | kristina.vermeersch@kuleuven.be |
| Amber Beersaerts | Contact | 016338928 | +32 | amber.beersaerts@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens, MD, PhD | UZ/KU Leuven - Belgium | Study Chair |
| Mona Bafadhel, MD, PhD | King's College London - UK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Hospital | Recruiting | Linz | Austria |
Not provided
| Label | URL |
|---|---|
| ERJ Editorial 2020 - The CICERO (Collaboration In COPD ExaceRbatiOns) Clinical Research Collaboration | View source |
| Int J COPD 2021 - Standardisation of Clinical Assessment, Management and Follow-Up of Acute Hospitalised Exacerbation of COPD: A Europe-Wide Consensus | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| INDUSTRY |
Not provided
Not provided
Not provided
| Will be assessed during 1 year, on visits 2-6 |
| Treatment intensification for respiratory reasons | A composite outcome measure defined as:
| Will be assessed during 1 year, on visits 2-6 |
| Treatment failure | A composite outcome measure defined as:
| Will be assessed during 1 year, on visits 2-6 |
| Severe treatment failure | As intensification of drug treatment regimens and treatment intensifications are country/region-specific and not always related to failure of disease control, severe treatment failure (STF) will be defined as the composite of:
| Will be assessed during 1 year, on visits 2-6 |
| Readmission for a severe COPD exacerbation | Readmission of the patient to the hospital for a severe COPD exacerbation | Will be assessed during 1 year, on visits 2-6 |
| New hospitalization for respiratory reasons | New admission of the patient to the hospital for respiratory reasons | Will be assessed during 1 year, on visits 2-6 |
| Hospital care intensification for respiratory reasons | A composite outcome measure defined as:
| Will be assessed during 1 year, on visits 2-6 |
| Time to | The time to the following outcomes will be measured:
| Will be assessed during 1 year, on visits 2-6 |
| Number of participants with a new or changed Do Not Resuscitate (DNR) code | The implementation of a new or changed DNR code during study participation will be measured.
DNR 1a: No CPR DNR 1b: No CPR + no intubation + NIV to be considered
Abbreviations: CPR, cardiopulmonary resuscitation; NIV, non-invasive ventilation; °, treatment of disabling symptoms to be prioritised, however, no life-prolonging interventions are to be continued | Will be assessed during 1 year, on visits 2-6 |
| Cumulative dose of systemic corticosteroids | The total dose of systemic corticosteroids administered during study participation will be measured. | Will be assessed during 1 year, on visits 2-6 |
| Total days in hospital | Total number of days spent in a hospital during study participation will be measured. | Will be assessed during 1 year, on visits 2-6 |
| Change in modified Medical Research Council (mMRC): a dyspnea scale | The change in the following patient reported outcome measures (PROM) will be measured: modified Medical Research Council (mMRC): a dyspnea scale
| Will be assessed during 1 year, on visits 2-6 |
| Change in COPD Assessment Test (CAT): a COPD impact scale | The change in the following patient reported outcome measures (PROM) will be measured: 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 | The change in the following patient reported outcome measures (PROM) will be measured: Patient Health Questionnaire-9 (PHQ-9): a depression scale
| Will be assessed during 1 year, on visits 2-6 |
| Change in Generalized Anxiety Disorder-7 (GAD-7): an anxiety scale | The change in the following patient reported outcome measures (PROM) will be measured: Generalized Anxiety Disorder-7 (GAD-7): a anxiety scale
| Will be assessed during 1 year, on visits 2-6 |
| Change in patient reported experience measure (PREM) | The change in the following PREM will be measured: 1. Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS): measuring patients' perceptions of their hospital experience -interpretation: higher scores indicate better outcome | Will be assessed during 1 year, on visits 2-6 |
| Change in comorbidities | Changes in baseline comorbidies (ie. the appearance of new or worsening of existing) will be measured | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker Eotaxin-3 (CCL26) | Eotaxin-3 is a small cytokine belonging to the CC chemokine family (called CCL26, Chemokine (C-C motif) ligand 26). Eotaxin-3 is chemotactic for eosinophils and basophils and elicits its effects by binding to the cell surface chemokine receptor CCR3. | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker IL-5 | Interleukin-5 (IL-5) acts on mature eosinophils, leading to proliferation, activation, differentiation, and survival; playing a critical role in the host immune response to infections. | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker IL-33 | Interleukin-33 (IL-33) is described as an inducer of type 2 immune responses, activating T helper 2 cells and mast cells. | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker MCP-4 (CCL13) | Monocyte chemotactic protein 4 (MCP-4), also called CCL13, is a major chemo-attractant for eosinophils, basophils, monocytes and T lymphocytes | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker TARC4 (CCL17) | Thymus and activation regulated chemokine (TARC), also known as CCL17, is a chemokine that induces chemotaxis of Type 2 T helper (Th2) cells. | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker IP-10 (CXCL10) | Interferon gamma-induced protein 10 (IP-10 (CXCL10)) chemoattracts Th1 lymphocytes and monocytes, and inhibits cytokine-stimulated hematopoietic progenitor cell proliferation. | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker IL1A | Interleukin 1 alpha (IL1A) stimulates the activity of genes involved in inflammation and immunity | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker IL-8 | Interleukin 8 (IL-8) is a chemokine produced by macrophages and other cell types such as epithelial cells, airway smooth muscle cells and endothelial cells; which attracts and activates neutrophils in inflammatory regions | Will be assessed during 1 year, on visits 2-6 |
| Change in biomarker GM-CSF | Granulocyte-macrophage colony-stimulating factor (GM-CSF) regulates proliferation and/or activation of monocytes, macrophages, neutrophils and eosinophils | Will be assessed during 1 year, on visits 2-6 |
| University Hospital Vienna | Not yet recruiting | Vienna | Austria |
|
| CHU St-Pierre Brussels | Recruiting | Brussels | 1000 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
|
| CHU UCL Namur Site Godinne | Recruiting | Yvoir | 5530 | Belgium |
|
| CHU de Lille | Not yet recruiting | Lille | 59000 | France |
|
| Cochin Hospital | Not yet recruiting | Paris | France |
|
| LungenClinic | Recruiting | Großhansdorf | Germany |
|
| Klinikum Itzehoe | Recruiting | Itzehoe | 25524 | Germany |
|
| University Hospital Schleswig-Holstein | Not yet recruiting | Kiel | Germany |
|
| University Medical Centre of Gießen & Marburg | Recruiting | Marburg | Germany |
|
| University Hospital of Ferrara | Not yet recruiting | Ferrara | Italy |
|
| UMC Groningen | Not yet recruiting | Groningen | 9713 | Netherlands |
|
| Maastricht University Medical Hospital | Not yet recruiting | Maastricht | Netherlands |
|
| University Hospital | Not yet recruiting | Golnik | Slovenia |
|
| Hospital Clinic de Barcelona | Not yet recruiting | Barcelona | Spain |
|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
|
| Gazi University Hospital | Recruiting | Ankara | 06560 | Turkey (Türkiye) |
|
| Glenfield Hospital | Recruiting | Leicester | United Kingdom |
|
| Guy's Saint Thomas | Not yet recruiting | London | United Kingdom |
|
| Royal Brompton Hospital | Active, not recruiting | London | United Kingdom |
| Churchil Hospital | Not yet recruiting | Oxford | United Kingdom |
|
| ERJ Open Research 2023 - Patients' Acceptance of Outcome and Experience Measurements During Hospitalisation for COPD Exacerbations: A Cicero CRC - ELF Online Patient Survey |
| View source |
| The CICERO website | View source |
| The ERS - CICERO CRC webpage | View source |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |