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Clinical Trial Summary

This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in subjects who have completed Study RIN-PH-304. This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, 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)(RIN-PH-304).

Clinical Trial Description

This is a multi-center, open-label study for eligible subjects who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304.

Subjects who provide informed consent for this open-label extension study on or prior to the final study visit of RIN-PH-304 may participate in the study, provided all other eligibility United Therapeutics Corp. RIN-PH-305 Original Protocol Lung Biotechnology PBC Inhaled Treprostinil Version Date 05 September 2018 Confidential Page 12 criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.

All subjects will reinitiate inhaled treprostinil at a dose of 3 breaths at 18 micrograms (mcg) 4 times daily (QID) during waking hours. Study drug doses should be maximized to tolerability throughout the study, and dose titrations should occur as rapidly as possible (as directed by the Investigator) with a target dosing of 12 breaths (72 mcg) four times a day (QID) or to maximum tolerability. If there are adverse events (AEs) that are dose related, the dosing can be adjusted to tolerability.

Study visits will occur at enrollment, Week 6, and quarterly thereafter. The study may be terminated at any time by the Sponsor for reasons that may include, but are not limited to, commercial availability of inhaled treprostinil for PH-COPD and Sponsor termination of the development for the indication of PH-COPD. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03794583
Study type Interventional
Source United Therapeutics
Status Enrolling by invitation
Phase Phase 3
Start date December 21, 2018
Completion date December 2020

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