Design: 12-week, multicenter, randomized, double-blind trial of TYVASO or placebo added to an ERA (bosentan) or a PDE-5i (sildenafil) in 235 clinically stable patients (82% female, 18% male) who were NYHA FC III (98%) or IV (2%) at baseline, with 6MWD between 200 m and 450 m.
How administered: TYVASO was initiated at 3 breaths (18 µg) per inhalation section. If clinically tolerated, dosing was increased over the first 2 weeks to reach a target dose of 9 breaths (54 µg) 4 times daily. Average time to target dose – ~3 weeks.
Primary Endpoint: Peak 6MWD at 12 weeks.
Secondary Endpoints: 12-week trough 6MWD, peak 6MWD at Day 1 and 6 weeks, quality of life, Borg Dyspnea Score, NYHA FC, clinical worsening, or signs and symptoms of PAH.