An observational study in Chronic Obstructive Pulmonary Disease Exacerbation, sponsored by Wim Janssens. Recruiting at 22 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Wim Janssens · Observational
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Wim Janssens is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with COPD, hospitalized for an acute exacerbation
Inclusion Criteria:
Exclusion Criteria:
All-cause mortality
Death from any cause
Time frame: Will be assessed during 1 year, on visits 2-6
Step-up in hospital care for respiratory reasons
A composite outcome measure defined as: 1. New hospitalization for respiratory reasons 2. Hospital care intensification from baseline (ie. within 24h from hospital admission) for respiratory reasons, including: * 2.1 Non-invasive respiratory therapy (oxygen by mask or nasal flow) * 2.2 Non-invasive respiratory therapy (oxygen by NIV or high flow) * 2.3 Invasive respiratory therapy (intubation and mechanical ventilation) * 2.4 Physiological support with inotropes
Time frame: Will be assessed during 1 year, on visits 2-6
Treatment intensification for respiratory reasons
A composite outcome measure defined as: 1. Prolongation of systemic corticosteroids \>5 days administered for the index acute exacerbation or first readmission for respiratory reasons 2. Upgrade of antibiotics administered for the index exacerbation or first readmission for respiratory reasons 3. New course of systemic corticosteroids for respiratory reasons 4. New course of antibiotics for respiratory reasons
Time frame: Will be assessed during 1 year, on visits 2-6
Treatment failure
A composite outcome measure defined as: 1. All-cause mortality 2. Step-up in hospital care for respiratory reasons 3. Treatment intensification for respiratory reasons
Time frame: 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: 1. All-cause mortality 2. Step-up in hospital care for respiratory reasons
Time frame: 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
Time frame: 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
Time frame: Will be assessed during 1 year, on visits 2-6
Hospital care intensification for respiratory reasons
A composite outcome measure defined as: 1. Non-invasive respiratory therapy (oxygen by mask or nasal flow) 2. Non-invasive respiratory therapy (oxygen by NIV or high flow) 3. Invasive respiratory therapy (intubation and mechanical ventilation) 4. Physiological support with inotropes
Time frame: Will be assessed during 1 year, on visits 2-6
Time to
The time to the following outcomes will be measured: 1. All-cause mortality 2. First hospital readmission for respiratory reasons 3. Hospital care intensification for respiratory reasons 4. Treatment intensification for respiratory reasons 5. Treatment failure 6. Severe treatment failure
Time frame: 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 0: do not restrict therapy (i.e. explicit statement not to withhold any life-sustaining interventions) * DNR 1: do not resuscitate, further specified as: DNR 1a: No CPR DNR 1b: No CPR + no intubation + NIV to be considered * DNR 2: do not extend therapy (i.e. no CPR + no intubation + no NIV) * DNR 3: discontinue therapy (i.e. no CPR + no intubation + no NIV + withdrawal of current treatment°) Abbreviations: CPR, cardiopulmonary resuscitation; NIV, non-invasive ventilation; °, treatment of disabling symptoms to be prioritised, however, no life-prolonging interventions are to be continued
Time frame: 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.
Time frame: 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.
Time frame: 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 * scale: 0 to 4 * interpretation: higher scores indicate worse outcome
Time frame: 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 * scale: 0 to 40 * interpretation: higher scores indicate worse outcome
Time frame: 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 * scale: 0 to 29 * interpretation: higher scores indicate worse outcome
Time frame: 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 * scale: 0 to 21 * interpretation: higher scores indicate worse outcome
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Will be assessed during 1 year, on visits 2-6
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Pulmonary Disease, Chronic Obstructive→
Wim Janssens