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NCT04737655: TRIMICU
Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care
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.
15 February 2023
Quick facts
| Lead sponsor | PARZIBUT Gilles |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 15 February 2021 |
| Primary completion | 15 February 2023 |
| Estimated completion | 15 May 2023 |
Drugs / interventions tested
- TRIMBOW® pressurised inhalation solution: Beclometasone dipropionate / formoterol fumarate /glycopyrronium 87/5/9 µg per inhalation
Conditions studied
- COPD Exacerbation — all drugs for COPD Exacerbation →
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.
Verify or expand the search:
- PubMed search for NCT04737655
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06347536 — Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease · Phase 3 · recruiting
- NCT06691399 — Role of Oral Care in Prevention of Nosocomial Pneumonia Among COPD Patients · NA · recruiting
- NCT05958563 — Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04737655 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PARZIBUT Gilles
- Last refreshed: 4 February 2021
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