Respiratory failure & ventilation
Safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) in ARDS patients: a randomised controlled trial
- Trial discontinued early after the first part for futility
Authors' conclusion
Inhaled PEG-ADM was well tolerated in patients with acute respiratory distress syndrome, but it did not improve clinical outcomes, which led to the early discontinuation after the first part of the trial for futility.
Study context
- Population
- Critically ill mechanically ventilated patients with ARDSrandomised
- Participants
- 90 participants
- Comparison
- Inhaled PEG-ADM 960 μg or 1920 μg vs placebo
- PEG-ADM 960 μgn = 29
- PEG-ADM 1920 μgn = 30
- Placebon = 31reference
- Primary endpoint
- Safety, efficacy (clinical utility index: composite of extravascular lung water index, oxygenation index, non-pulmonary SOFA score) and ventilator-free survival
- Follow-up
- Day 28
Methodological detailsPhase 2a/b, double-blind, placebo-controlled, multicentre
- Phase 2a/b
- Double-blind
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
Ventilator-free survival
Further findings
Overall mortality and need for continued ventilation · Days 28 and 60
- No significant differences
Safety
- Both doses well tolerated; adverse event profiles similar to placebo
Original publication
Safety and efficacy of inhaled PEG-ADM in ARDS patients: a randomised controlled trial. Crit Care. Published 23 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →