Parameter | VENTAVIS | Placebo |
---|---|---|
PVR (dyn•sec/cm5) | 1029±390 | 1041±493 |
mPAP (mmHg) | 53±12 | 54±14 |
CO (L/min) | 3.8±1.1 | 3.8±0.9 |
SVO2 (%) | 60±8 | 60±8 |
In the AIR pivotal trial hemodynamics were assessed at week 12 before inhalation in both groups (at least 2 hours after previous dose, trough) and after inhalation in the VENTAVIS group (approximately 15 minutes after dose, peak). The study included patients with chronic thromboembolic disease (CTEPH) and all etiologies of PAH.1
AIR Pivotal Trial Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of VENTAVIS in the treatment of PAH NYHA Functional Class III or IV (n=146). Clinical improvement is a combined endpoint defined as ≥10% increase in 6MWD, improvement in NYHA Functional Class, and absence of clinical deterioration or death.1,4