RIN-PH-201

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

RIN-PH-201 [NCT02630316]

Description: This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 75 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

Drug: Inhaled Treprostinil; Drug: Placebo


 

Primary Investigator: Engel

Drug/Device Information
To evaluate the safety and efficacy of inhaled treprostinil in subjects with PH associated with ILD including CPFE
Treprostinil is a chemically stable tricyclic analogue of prostacyclin
Treprostinil for inhalation (Tyvaso) is approved in the United States for the treatment of PAH (WHO Group I)
Randomized 1:1 between inhaled treprostinil and placebo
United Therapeutics Corp.