The CATALINA Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWim Janssens
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with COPD, hospitalized for an acute exacerbation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
All-cause mortality
Death from any cause
Time frame
Will be assessed during 1 year, on visits 2-6Secondary outcomes
1
Step-up in hospital care for respiratory reasons
A composite outcome measure defined as: 1. New hospitalization for respiratory reasons 2. Hospital care intensification from baseline (ie. within 24h from hospital admission) for respiratory reasons, including: * 2.1 Non-invasive respiratory therapy (oxygen by mask or nasal flow) * 2.2 Non-invasive respiratory therapy (oxygen by NIV or high flow) * 2.3 Invasive respiratory therapy (intubation and mechanical ventilation) * 2.4 Physiological support with inotropes
Time frame
Will be assessed during 1 year, on visits 2-62
Treatment intensification for respiratory reasons
A composite outcome measure defined as: 1. Prolongation of systemic corticosteroids \>5 days administered for the index acute exacerbation or first readmission for respiratory reasons 2. Upgrade of antibiotics administered for the index exacerbation or first readmission for respiratory reasons 3. New course of systemic corticosteroids for respiratory reasons 4. New course of antibiotics for respiratory reasons
Time frame
Will be assessed during 1 year, on visits 2-63
Treatment failure
A composite outcome measure defined as: 1. All-cause mortality 2. Step-up in hospital care for respiratory reasons 3. Treatment intensification for respiratory reasons
Time frame
Will be assessed during 1 year, on visits 2-64
Severe treatment failure
As intensification of drug treatment regimens and treatment intensifications are country/region-specific and not always related to failure of disease control, severe treatment failure (STF) will be defined as the composite of: 1. All-cause mortality 2. Step-up in hospital care for respiratory reasons
Time frame
Will be assessed during 1 year, on visits 2-6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wim Janssens
Lead sponsor
KU Leuven
Sponsor institution
European Respiratory Society
Collaborator
AstraZeneca
Collaborator
Roche Pharma AG
Collaborator
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov