Status:
UNKNOWN
Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care
Lead Sponsor:
PARZIBUT Gilles
Conditions:
COPD Exacerbation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 loc...
Detailed Description
In the ICU, the standard of care is still focused on the use of aerosolized therapies. These therapies are time consuming and largely used unless the lack of proven superiority in comparison with Pres...
Eligibility Criteria
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
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
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04737655
Start Date
February 15 2021
End Date
May 15 2023
Last Update
February 4 2021
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