NCT05008081

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
9 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2022Dec 2026

First Submitted

Initial submission to the registry

August 6, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

August 6, 2021

Last Update Submit

November 13, 2024

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Keywords

COPDExacerbationHospitalization

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Death from any cause

    Will be assessed during 1 year, on visits 2-6

Secondary Outcomes (26)

  • Step-up in hospital care for respiratory reasons

    Will be assessed during 1 year, on visits 2-6

  • Treatment intensification for respiratory reasons

    Will be assessed during 1 year, on visits 2-6

  • Treatment failure

    Will be assessed during 1 year, on visits 2-6

  • Severe treatment failure

    Will be assessed during 1 year, on visits 2-6

  • Readmission for a severe COPD exacerbation

    Will be assessed during 1 year, on visits 2-6

  • +21 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with COPD, hospitalized for an acute exacerbation

You may qualify if:

  • 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)
  • Voluntary written informed consent of the participant or his/her representative obtained prior to any study procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Kepler University Hospital

Linz, Austria

RECRUITING

CHU St-Pierre Brussels

Brussels, 1000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

CHU UCL Namur Site Godinne

Yvoir, 5530, Belgium

RECRUITING

CHU de Lille

Lille, 59000, France

NOT YET RECRUITING

Cochin Hospital

Paris, France

NOT YET RECRUITING

LungenClinic

Großhansdorf, Germany

RECRUITING

Klinikum Itzehoe

Itzehoe, 25524, Germany

RECRUITING

University Medical Centre of Gießen & Marburg

Marburg, Germany

NOT YET RECRUITING

University Hospital of Ferrara

Ferrara, Italy

NOT YET RECRUITING

UMC Groningen

Groningen, 9713, Netherlands

NOT YET RECRUITING

Maastricht University Medical Hospital

Maastricht, Netherlands

NOT YET RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

NOT YET RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Glenfield Hospital

Leicester, United Kingdom

NOT YET RECRUITING

Guy's Saint Thomas

London, United Kingdom

NOT YET RECRUITING

Royal Brompton Hospital

London, United Kingdom

ACTIVE NOT RECRUITING

Churchil Hospital

Oxford, United Kingdom

NOT YET RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

* Blood (serum/plasma) * Sputum * Nasopharygeal swab * Urine

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wim Janssens, MD, PhD

    UZ/KU Leuven - Belgium

    STUDY CHAIR

  • Mona Bafadhel, MD, PhD

    King's College London - UK

    STUDY CHAIR

Central Study Contacts

Kristina Vermeersch, PhD

CONTACT

016342284kristina.vermeersch@kuleuven.be

Amber Beersaerts

CONTACT

016338928amber.beersaerts@kuleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 17, 2021

Study Start

October 25, 2022

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations

SE(1)FR(2)AU(1)BE(3)NL(2)ES(1)GB(4)DE(3)IT(1)