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

• Status: Not yet recruiting
• Trial end date: 2023-05-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PARZIBUT Gilles
• Treatments: Beclomethasone; Formoterol Fumarate; Glycopyrrolate

Criteria

Inclusion Criteria:

• Maintenance therapy (LAMA or LABA) for COPD

• Age >18

• Admission for AE of COPD

• Signed Inform consent (see protocol attached)

• Admitted in ICU >24h and less than 72h

Exclusion Criteria:

• No CI for studied medication

• Not treated with studied medication for at least 3 months

• Admitted in ICU for AE of COPD within the past 3 months

• Intolerance to studied medication

• Hospitalized since >6 days

• ARDS condition (PAFI <200)

• Admitted in ICU >72H

• Patient with severe asthma

• The use of high dose of ICS as baseline therapy

• Right/left heart failure

• Immunocompromized

• Acute myocardial infaction

• Left heart insufficiency (LVEF<35%)

• Stroke <6 months prior to hospital admission