Inhaled AP301 for treatment of pulmonary edema in mechanically ventilated patients with acute respiratory distress syndrome: a phase IIa randomized placebo-controlled trial

Table 3 Respiratory parameters at screening according to SOFA stratification

	SOFA A		SOFA B
Parameter	AP301 (n = 8)	Placebo (n = 7)	AP301 (n = 12)	Placebo (n = 13)
PaO₂/FiO₂, mmHg	180 ± 63	188 ± 46	147 ± 55	156 ± 44
Murray LIS	2.5 ± 0.4	2.6 ± 0.3	3.2 ± 0.3	2.9 ± 0.6
Oxygenation index	9.3 ± 4.5	7.8 ± 2.2	15.1 ± 5.1	12.1 ± 5.5
Prone positioning	2 (25)	0	4 (33.3)	5 (38.5)
ECMO therapy	0	0	4 (33.3)	1 (7.8)
EVLWI, mL/kg PBW	10.2 ± 1.4	12.7 ± 4.3	15.8 ± 6.2	12.5 ± 5.5
Peak ventilator pressure, cmH₂O	23 ± 3	23 ± 5	28 ± 4	26 ± 4
Driving pressure, cmH₂O	14 ± 3	13 ± 5	15 ± 3	15 ± 4
Mean airway pressure, cmH₂O	14 ± 2	14 ± 1	19 ± 4	16 ± 3
PEEP, cmH₂O	10 ± 2	10 ± 1	13 ± 3	11 ± 2
V_T, mL/kg PBW	7.7 ± 1.3	8.0 ± 1.3	6.0 ± 1.5	7.6 ± 1.7
Respiratory rate, per min	16 ± 2	17 ± 2	19 ± 7	18 ± 4
PaCO₂, mmHg	45 ± 5	40 ± 3	48 ± 7	47 ± 10
pH	7.43 ± 0.07	7.43 ± 0.03	7.33 ± 0.10	7.38 ± 0.08

Data are presented as mean ± SD or n (%)
ECMO extracorporeal membrane oxygenation, EVLWI extravascular lung water index, LIS lung injury score, PBW predicted body weight, PEEP positive end expiratory pressure, SOFA sequential organ failure assessment, V _T tidal volume

ISSN: 1364-8535