Clinical trial NCT05008081: The CATALINA Study
Official title: An International Multi-centre Prospective Cohort Study in Patients Hospitalized for an Acute Exacerbation of COPD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
Keywords: COPD
Exacerbation
Hospitalization
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: European Respiratory Society
name: AstraZeneca
name: Roche Pharma AG
name: GlaxoSmithKline
First posted: 2021-08-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD, hospitalized for an acute exacerbation

Brief 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.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: Will be assessed during 1 year, on visits 2-6
Secondary outcomes:
measure: Step-up in hospital care for respiratory reasons
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Treatment intensification for respiratory reasons
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Treatment failure
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Severe treatment failure
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Readmission for a severe COPD exacerbation
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: New hospitalization for respiratory reasons
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Hospital care intensification for respiratory reasons
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Time to
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Number of participants with a new or changed Do Not Resuscitate (DNR) code
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Cumulative dose of systemic corticosteroids
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Total days in hospital
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in modified Medical Research Council (mMRC): a dyspnea scale
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in COPD Assessment Test (CAT): a COPD impact scale
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in Patient Health Questionnaire-9 (PHQ-9): a depression scale
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in Generalized Anxiety Disorder-7 (GAD-7): an anxiety scale
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in patient reported experience measure (PREM)
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in comorbidities
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker Eotaxin-3 (CCL26)
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker IL-5
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker IL-33
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker MCP-4 (CCL13)
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker TARC4 (CCL17)
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker IP-10 (CXCL10)
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker IL1A
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker IL-8
timeFrame: Will be assessed during 1 year, on visits 2-6
measure: Change in biomarker GM-CSF
timeFrame: Will be assessed during 1 year, on visits 2-6
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
city: Brussels
country: Belgium
facility: CHU St-Pierre Brussels
city: Leuven
country: Belgium
facility: UZ Leuven
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site Godinne
city: Lille
country: France
facility: CHU de Lille
city: Paris
country: France
facility: Cochin Hospital
city: Großhansdorf
country: Germany
facility: LungenClinic
city: Itzehoe
country: Germany
facility: Klinikum Itzehoe
city: Marburg
country: Germany
facility: University Medical Centre of Gießen & Marburg
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Guy's Saint Thomas
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Oxford
country: United Kingdom
facility: Churchil Hospital
Study officials:
affiliation: UZ/KU Leuven - Belgium
name: Wim Janssens, MD, PhD
role: STUDY_CHAIR
affiliation: King's College London - UK
name: Mona Bafadhel, MD, PhD
role: STUDY_CHAIR
References: