The CATALINA Study

Wim Janssens

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease Exacerbation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05008081

S64324

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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