The CATALINA study (s64324)
Research type
Research Study
Full title
The CATALINA Study - A European multi-centre prospective cohort study \nin patients hospitalized for an acute exacerbation of COPD
IRAS ID
322442
Contact name
Mona Bafadhel
Contact email
Sponsor organisation
UZ Leuven
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Exacerbations of chronic obstructive pulmonary disease (COPD) requiring hospitalisation are serious and complex events that are poorly defined, with treatment and follow-up varying greatly across Europe. They are associated with significant morbidity and high mortality (11% in the first 3 months). This is mainly due to the poor characterization of exacerbations and a uniform approach of treating everyone with systemic corticosteroids and antibiotics, without taking into account the vast differences in event cause, course and outcomes. There is a high clinical need for deeper understanding of these events, as well as tailoring treatment and follow-up to the needs of the patient. \n\nThe CATALINA study is a clinical study in patients hospitalised for an acute COPD exacerbation, which aims to develop a detailed European data and biobank enabling accurate characterization of exacerbations. The objective is to enrol 1000 patients with 1-year follow-up by the end of 2025, in 20 centres across Europe and the UK. Eligible participants are adult patients diagnosed with COPD, hospitalised for a severe exacerbation and treated with antibiotics and/or systemic corticosteroids.\n\nThe study is designed to be embedded in routine clinical care following a severe exacerbation requiring hospitalisation, and data and sample collection was based on a prior European consensus obtained from COPD experts and patients on which clinical assessments to perform during and after the acute event. During 1-year study participation, clinical data and biological samples (blood, sputum, nasal swab and urine) are collected during 6 scheduled study visits. Three study visits occur during hospitalisation (enrolment within 48-hours of hospital admission, at 72-hours after enrolment, day of discharge). After hospital discharge, 3 follow-up study visits are planned during routine clinical follow-up (at 3, 6 and 12 months). In case of a first re-admission for respiratory reasons during the follow-up period, the first 3 study visits are repeated.\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0065
Date of REC Opinion
21 Mar 2023
REC opinion
Favourable Opinion