CICERO's Registry 
The CATALINA study

A pan-European Consortium

CICERO will establish a pan-European Consortium, and aims to initiate the CATALINA study 
in 20 centres across Europe by the end of its first lifecycle (3 years). 

The first wave of 11 centres in the CICERO network will span across 8 EU countries. 

National Leads

National Leads

Prof. dr. W. Janssens
Leuven, BELGIUM

Prof. dr. M. Bafadhel
London, U.K.

Dr. F. Franssen
Maastricht, NETHERLANDS

Dr. P.-R. Burgel
Paris, FRANCE

Dr. T. Greulich
Marburg, GERMANY

Dr. M. Contoli
Ferrara, ITALY

Dr. A. Huerta-Garcia
Barcelona, SPAIN

Dr. L. Vanfleteren
Göthenburg, SWEDEN

Objectives

1)   To generate high-quality longitudinal clinical data (incl. bio-samples) covering a pan-European real-life population of patients with COPD, hospitalized for an exacerbation, in all age groups and stages of disease severity 

2)   To establish standard operating procedures for sample collection, processing and local bio-banking
 

3)   To determine phenotypes of exacerbations, identify biomarkers and treatable traits; and explore how these relate to known exacerbation phenotypes 

4)   To better understand the natural history and prognosis of COPD in patients experiencing severe exacerbations with the aim of creating and validating prognostic tools to support medical decision making 

5)   To cultivate the development of a phenotyped COPD patient database in relation to the type of exacerbation for future trial cohorts 

6)   To serve as an exploratory dataset to design future interventions studies for specific patient subgroups 

 support

Study Specifics

Study design

 A multi-centre prospective interventional cohort study 

Indication

Patients with Chronic Obstructive Pulmonary Disease (COPD) hospitalised for an acute exacerbation (i.e. index)

Planned cohort

 A total of 1000 patients by the end of the first lifecycle of CICERO (3 years), with completed 1-year follow-up data in the subsequent year 

Duration

Longitudinal follow-up of 1 year 


Intervention

Collection of bio-samples (i.e. blood, sputum, nasal swab and urine), in addition to clinical data (i.e. standard care, non-standard care and centre-specific).

Study assessments were defined following a Delphi Survey reaching an EU-wide consensus on the most important process and outcome parameters to be measured during and after a severe exacerbation.

Outcomes

  • Mortality 
  • Admission to the ICU 
  • Implementation of a DNR code 
  • Readmission for a severe COPD exacerbation 
  • Experienced treatment failure 

 

Study Visits

Six scheduled study visits:
V1 –  Day 1: informed consent within 24h of admission
V2 –  Day 3: at 72h after consent or earlier if discharged
V3 –  Day X: discharge (only if ≥6 days in hospital)
V4 –  Day 90: at 3 months from study inclusion
V5 –  Day 180: at 6 months from study inclusion
V6 –  Day 365: at 12 months from study inclusion 

Three unscheduled study visits:
During first readmission for respiratory reasons: 
UV1 –  Repeat V1 assessments
UV2 –  Repeat V2 assessments
UV3 –  Repeat V3 assessments

Eligibility

Inclusion ciriteria

1.       Age 18 years and older

2.       Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test with an FEV1/FVC < 0.7)

3.       Current hospitalization with suspicion of an acute exacerbation of COPD 

4.       Inclusion within 24 hours post hospital admission 

5.       Voluntary written informed consent of the participant, or his/her legally authorized representative obtained prior to any study procedure


Exclusion criteria

 1.      Patients unwilling or unable to comply with study procedures 

2.       Patients not requiring treatment with systemic corticosteroids, antibiotics or both as a minimum therapy for the index AECOPD 

3.       Patients with a confirmed positive test result for COVID19 at admission, or those highly suspected based on clinical examination