drugset / Trial / NCT04737655
Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Formoterol | Other / unclassified | 5 ug | Inhaled |
| Comparator | Glycopyrronium | Unknown | 9 ug | Inhaled |
| Comparator | beclomethasone dipropionate | Other / unclassified | 87 ug | Inhaled |