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

NCT04737655 | Unknown Phase 4

• 1 other identifier: B7072020000051
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Composite primary Endpoint associating the ICU Length of stay (in days) and Time of Ventilation (in days also)

  2 years

Secondary Outcomes (1)

• Assessment of the risk of exacerbation in the year.

  2 years

Study Arms (2)

TRIMBOW + Standard of care

ACTIVE COMPARATOR

1. Inclusion * 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 2. Exclusion * 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 Patients will be separated in 2 randomized groups (Trimbow + SOC versus SOC) 1:1.

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

standard of care

NO INTERVENTION

Interventions

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

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

TRIMBOW + Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PARZIBUT Gilles: lead

MeSH Terms

Interventions

Formoterol Fumarate; Glycopyrrolate

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, adjoint head of clinics in university hospital of liege, departement ICU

Model Details: The study population will consist of one cohort of patients admitted in our hospital (CHU DE LIEGE) for acute exacerbation of COPD. The COPD has to be diagnosed based on the international recommendations (GOLD recommendations). The patient has to suffer from an acute severe exacerbation requiring an ICU stay of at least 24hours. Patients will be separated in 2 randomized groups (Trimbow + SOC versus SOC) 1:1. A total of 200 patients will be randomized in this study following the inclusion and exclusions criteria.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: February 4, 2021
• Study Start: February 15, 2021
• Primary Completion: February 15, 2023
• Study Completion: May 15, 2023
• Last Updated: February 4, 2021

Record last verified: 2021-02