Inhaled Treprostinil in PH-COPD

Condition: Pulmonary hypertension, chronic obstructive pulmonary disease

Eligibility

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of pulmonary hypertension due to chronic obstructive pulmonary disease (PH-COPD); clinical diagnosis of COPD
  • Willing to undergo right heart catheterization during first screening visit if a prior right heart catheterization has not been performed within the past 12 months

Key Exclusion Criteria:

  • Diagnosis of either pulmonary arterial hypertension or pulmonary hypertension due to reasons other than COPD
  • Confirmed diagnosis of idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease, or interstitial lung disease

Study Name

RIN-PH-304: A Phase III, Randomized, Placebo-Controlled, Double-Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) (IRB no. 0000320)

Summary

This study focuses on individuals who have pulmonary hypertension (PH) due to chronic obstructive pulmonary disease (COPD) [PH-COPD] and thus have high blood pressure in their lungs. The purpose of the study is to evaluate the safety and effectiveness of inhaled treprostinil in improving exercise ability in patients with PH-COPD when compared to an inactive solution (placebo). Inhaled treprostinil is a medication that is given by a handheld inhalation device called the Tyvaso Inhalation System. Inhaled treprostinil (brand name Tyvaso) is approved by the U.S. Food and Drug Administration (FDA) for various conditions, but it is not approved by the FDA for the treatment of PH-COPD.

Participants will be randomly assigned to one of two groups. The first group will receive inhaled treprostinil in the first treatment period and then placebo in the second. The other group will receive a placebo in the first treatment period and then inhaled treprostinil in the second.

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