Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 235
Healthy volunteers: no

Brief summary:
This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

Detailed description:
Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable dose of sildenafil for at least three months prior to study start were randomized to either treprostinil inhalation solution or matching placebo.

Administration of study medication was performed by inhalation with the OPTINEB™ ultrasonic nebulizer.

The proposed dosing regimen was four times daily-upon awakening, at midday, evening (dinner time) and bedtime.

After a patient has completed the twelve-week study period, they were given the option of enrolling into an open-label extension study.

Arms:
arm 1: 0.9 mg/mL treprostinil for inhalation supplied in 2.9mL ampoules for use in ultra sonic nebulizer arm 2: Placebo inhalation solution for use in ultrasonic nebulizer

Interventions: intervention 1: Inhaled treprostinil intervention 2: Placebo inhalation solution
Intervention descriptions: intervention 1: Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil. intervention 2: Doses are titrated to 9 breaths four times daily.

Protocol document: