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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 (INCREASE)

General Information

Age Group

Adult

Status

Active

Protocol Number

RIN-PH-201

Background Information

The purpose of this research study is to investigate the safety and how well inhaled treprostinil works in subjects with PH associated with interstitial lung disease (ILD) or combined pulmonary fibrosis and emphysema (CPFE).

National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT02630316

Offered At

Inova Heart and Vascular Institute, Advanced Lung Disease and Transplant Clinic, 3300 Gallows Road, Falls Church, VA 22042

Principal Investigator

Christopher King, MD

Eligibility Information

Eligibility Information (brief):

  • Males and females aged 18-79
  • Confirmed diagnosis of WHO Group 3 PH associated with:
    • Idiopathic interstitial pneumonia (IIP)
    • Chronic hypersensitivity pneumonitis (CHP)
    • Occupational or environmental lung disease (drug or radiation-induced)
    • Combined pulmonary fibrosis and emphysema (CPFE)
  • Baseline diffusing capacity of the lungs for carbon monoxide (DLCO) < 50%
  • Baseline 6MWD ≥ 100 meters
  • Right heart catheterization (RHC) within one year prior to randomization
  • Has not received any PAH approved therapy within 60 days of randomization

Ineligibility Information

  • Diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than WHO Group 3 PH-ILD
  • Intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
  • Received any PAH approved therapy including: prostacyclin therapy, 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
  • Evidence of clinically significant left-sided heart disease as defined by:
    • a. PCWP > 15 mmHg
    • b. Left ventricular ejection fraction < 40%
  • Receiving > 10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline