drugset / Trial / NCT04737655

Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care

NCT04737655

Phase 4 Unknown 200 enrolled PARZIBUT Gilles
RandomizedParallel-groupOpen-labelPrevention

Summary

Objective: To evaluate non-inferiority of Trimbow, an approved therapy for treatment of severe COPD, in ICU compared to the standard of care which is based on the same therapeutic approach. Study location: CHU Sart-Tilman, 4000 Liège, Belgium Study duration: 2 years Type : Interventional Methodology: Prospective clinical trial Number of patients: 200 (randomized 1:1) Main Inclusion criteria : * Maintenance therapy (LAMA or LABA) for COPD * Age \>18 * Admission for AE of COPD * Signed Inform consent * Admitted in ICU \>24h

Timeline

Start
2021-02-15
Primary completion
2023-02-15
Completion
2023-05-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Formoterol Other / unclassified 5 ug Inhaled
Comparator Glycopyrronium Unknown 9 ug Inhaled
Comparator beclomethasone dipropionate Other / unclassified 87 ug Inhaled