The CATALINA Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease Exacerbation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, France, Germany, Italy +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An International Multi-centre Prospective Cohort Study in Patients Hospitalized for an Acute Exacerbation of COPD
Overview
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.
Primary outcome measures
- All-cause mortality [Time frame: Will be assessed during 1 year, on visits 2-6]
Secondary outcome measures (12)
- Step-up in hospital care for respiratory reasons [Time frame: Will be assessed during 1 year, on visits 2-6]
- Treatment intensification for respiratory reasons [Time frame: Will be assessed during 1 year, on visits 2-6]
- Treatment failure [Time frame: Will be assessed during 1 year, on visits 2-6]
- Severe treatment failure [Time frame: Will be assessed during 1 year, on visits 2-6]
- Readmission for a severe COPD exacerbation [Time frame: Will be assessed during 1 year, on visits 2-6]
- New hospitalization for respiratory reasons [Time frame: Will be assessed during 1 year, on visits 2-6]
- Hospital care intensification for respiratory reasons [Time frame: Will be assessed during 1 year, on visits 2-6]
- Time to [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 [Time frame: Will be assessed during 1 year, on visits 2-6]
- Cumulative dose of systemic corticosteroids [Time frame: Will be assessed during 1 year, on visits 2-6]
- Total days in hospital [Time frame: Will be assessed during 1 year, on visits 2-6]
- Change in modified Medical Research Council (mMRC): a dyspnea scale [Time frame: Will be assessed during 1 year, on visits 2-6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- LungenClinic — Großhansdorf
- Klinikum Itzehoe — Itzehoe
- University Hospital Schleswig-Holstein — Kiel
- University Medical Centre of Gießen & Marburg — Marburg
United Kingdom · 4 centers
- Glenfield Hospital — Leicester
- Guy's Saint Thomas — London
- Royal Brompton Hospital — London
- Churchil Hospital — Oxford
Belgium · 3 centers
- CHU St-Pierre Brussels — Brussels
- UZ Leuven — Leuven
- CHU UCL Namur Site Godinne — Yvoir
Austria · 2 centers
- Kepler University Hospital — Linz
- University Hospital Vienna — Vienna
France · 2 centers
- CHU de Lille — Lille
- Cochin Hospital — Paris
Netherlands · 2 centers
- UMC Groningen — Groningen
- Maastricht University Medical Hospital — Maastricht
Italy · 1 center
- University Hospital of Ferrara — Ferrara
Slovenia · 1 center
- University Hospital — Golnik
Spain · 1 center
- Hospital Clinic de Barcelona — Barcelona
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Turkey (Türkiye) · 1 center
- Gazi University Hospital — Ankara
Identifiers
NCT: NCT05008081 · S64324