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NCT04737655: TRIMICU

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

Status unknown Phase 4 Last updated 4 February 2021
What this trial tests

Phase 4 trial testing TRIMBOW® pressurised inhalation solution: Beclometasone dipropionate / formoterol fumarate /glycopyrronium 87/5/9 µg per inhalation in COPD Exacerbation in 200 participants. Status unknown.

Timeline
15 February 2021
Primary endpoint
15 February 2023
15 May 2023

Quick facts

Lead sponsorPARZIBUT Gilles
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment200
Start date15 February 2021
Primary completion15 February 2023
Estimated completion15 May 2023

Drugs / interventions tested

Conditions studied

Sponsor

PARZIBUT Gilles

Who can join

18 and older, any sex, with COPD Exacerbation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for COPD Exacerbation

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04737655.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing