The CATALINA Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Chronic Obstructive Pulmonary Disease Exacerbation
Disease Progression
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Clinical Trial Details

NCT number	NCT05008081
Study type	Observational [Patient Registry]
Source	KU Leuven
Contact	Kristina Vermeersch, PhD
Phone	016342284
Email	kristina.vermeersch@kuleuven.be
Status	Recruiting
Phase
Start date	October 25, 2022
Completion date	December 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06118684` - Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on Systemic Exposure of Midazolam and Digoxin	Phase 1
Recruiting	`NCT05808621` - Muscle Oxygenation in Chronic Obstructive Pulmonary Disease
Not yet recruiting	`NCT05769738` - The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation	Phase 3
Recruiting	`NCT04816695` - Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)	N/A
Completed	`NCT05991778` - Bioelectrical Impedance in Monitoring Hyperhydration and Polyneuromyopathy in Critically Ill Patients
Completed	`NCT05079009` - Effects of Blood Pulsatility on Von Willebrand Factor During ECCO2R	N/A
Not yet recruiting	`NCT06105814` - Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease	N/A
Completed	`NCT05699720` - Acute Exacerbation of COPD and Nebulized Magnesium Sulphate	N/A
Recruiting	`NCT04223050` - Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation	Phase 4
Terminated	`NCT04828837` - Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects	N/A
Completed	`NCT05776654` - Wearable Devices in the Recovery Phase of Acute Exacerbations of COPD (AECOPDs)
Completed	`NCT05691387` - Comparison of Active Cycle of Breathing Technique and Pursed Lip Breathing With TheraPep	N/A
Completed	`NCT04769505` - Mindfulness-based Interventions in COPD Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.