The CATALINA Study

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:

  • visit 1: within 48h of hospital admission, study inclusion (Day 1)

  • visit 2: at 72h after study inclusion (Day 3)

  • visit 3: at hospital discharge, at investigator's discretion (Day X)

• 3 study visits will be scheduled during the outpatient setting:

  • visit 4: at 3 months after study inclusion (Day 90)

  • visit 5: at 6 months after study inclusion (Day 180)

  • visit 6: at 12 months after study inclusion (Day 365)

• 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:

  • unscheduled visit 1: within 48h of first hospital readmission

  • unscheduled visit 2: within 72h of first hospital readmission

  • unscheduled visit 3: at hospital discharge for first hospital readmission

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.