INCREASE 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

IRB Protocol #: 1608017513

Overview: The purpose of this research study is to investigate the safety of and to determine if and how well inhaled treprostinil works in subjects with pulmonary hypertension (PH) associated with interstitial lung disease (ILD) or combined pulmonary fibrosis and emphysema (CPFE).  This study will look at your ability to exercise after taking the study drug in order to determine if and how well the study drug works.

This trial is funded by United Therapeutics.

Eligible patients:

• Must have a confirmed diagnosis of World Health Organization (WHO) Group 3 PH based on computed tomography (CT) imaging, which demonstrates evidence of diffuse parenchymal lung disease performed within 6 months prior to randomization.
• May have any form of ILD or CPFE, or a right heart catheterization (RHC), within 1 year prior to randomization.

Patients cannot participate if they have:

• Received any PAH approved therapy including: prostacyclin therapy (ie, epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonist (selexipag), endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor (PDE5-I), or soluble guanylate cyclase (sGC) stimulator within 60 days of randomization.
• Used any investigational drug/device, or participated in any investigational study with therapeutic intent within 30 days prior to randomization.

Contact:

Dr. Irina Sobol
Principle Investigator
Email: irs9009@med.cornell.edu
Phone: (212) 746-2381

Melissa Ricketts, MSHS, CCRC
Research Coordinator
Email: mdr2001@med.cornell.edu
Phone: (212) 746-2698