NCT05008081

The CATALINA Study

An International Multi-centre Prospective Cohort Study in Patients Hospitalized for an Acute Exacerbation of COPD

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Wim Janssens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Chronic Obstructive Pulmonary Disease Exacerbation

Timeline

• Start date: 2022-10-25
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-08-17
• Last updated: 2024-11-15

Locations

18 sites across 9 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom