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

NCT04737655 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-02-04

No results posted yet for this study

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

Conditions

  • COPD Exacerbation

Interventions

DRUG

TRIMBOW® pressurised inhalation solution: Beclometasone dipropionate / formoterol fumarate /glycopyrronium 87/5/9 µg per inhalation

Evaluate Trimbow associated with the standard of care in comparison with the standard of care alone.

Sponsors & Collaborators

  • PARZIBUT Gilles

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737655 on ClinicalTrials.gov