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The CATALINA Study

Sponsor: Wim Janssens

NCT ID: NCT05008081

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 65 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

The CATALINA Study is looking at people having a sudden flare-up (exacerbation) of chronic obstructive pulmonary disease (COPD), a lung condition that makes breathing difficult. The study takes place while people are already in hospital. The sponsor is listed as Wim Janssens.

Who can take part

  • Aged 18 or older
  • Diagnosed with COPD by a doctor, based on your medical history or a breathing test
  • Currently in hospital with a suspected sudden flare-up of COPD
  • Joined the study within 48 hours of being admitted to hospital
  • Given written informed consent (you or your representative) before any study procedures

Who may not be able to

  • Unwilling or unable to follow the study procedures
  • Not needing treatment with steroid tablets, antibiotics, or both for this flare-up
  • A confirmed positive COVID-19 test, or doctors strongly suspect COVID-19

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2022-10-25
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive pulmonary disease exacerbation
  • • Clinical study - 1,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with chronic obstructive pulmonary disease exacerbation

Where?

  • • Leicester - Glenfield Hospital
  • • London - Guy's Saint Thomas
  • • London - Royal Brompton Hospital
  • • Oxford - Churchil Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

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.

Chronic Obstructive Pulmonary Disease Exacerbation

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

confirmed positive

What the study is looking for

  • ✓Age 18 years and older
  • ✓Established diagnosis of COPD by medical doctor (based on clinical history OR lung function test with an...
  • ✓Current hospitalization with suspicion of an acute exacerbation of COPD (AECOPD)
  • ✓Inclusion within 48 hours post hospital admission
  • ✓Voluntary written agreement to take part of the participant or his/her representative obtained prior to any study procedure

Who cannot take part

  • ✗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...
  • ✗Patients with a confirmed positive test result for COVID19, or those highly suspected based on clinical examination
See the full 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

Where Is This Study? (4 UK sites)

Glenfield Hospital

Leicester, United Kingdom

Recruiting
Site contact (verified)
Neil Greening, MDPrincipal Investigator
Hamish McAuley, MDhjcm1@leicester.ac.uk

Guy's Saint Thomas

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Mona Bafadhel, MDPrincipal Investigator

Royal Brompton Hospital

London, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Churchil Hospital

Oxford, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Sanjay Ramakrishnan, MD, PhDPrincipal Investigator
Sanjay Ramakrishnan, MDsanjay.ramakrishnan@ndm.ox.ac.uk

How to Get in Touch

Kristina Vermeersch, PhD

Sponsor contact

CONTACT

016342284 kristina.vermeersch@kuleuven.be

Amber Beersaerts

Sponsor contact

CONTACT

016338928 amber.beersaerts@kuleuven.be
Data sourced from ClinicalTrials.gov · Last verified: 2026-05