Clinical Trials Logo

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
Contact
Status Enrolling by invitation
Phase Phase 3
Start date December 21, 2018
Completion date December 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Recruiting NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Recruiting NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
Not yet recruiting NCT02748798 - Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders Early Phase 1
Recruiting NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Recruiting NCT02557178 - Home-Based Health Management of COPD Patients Phase 2
Active, not recruiting NCT02690038 - Ig PRx in AECOPD: Pilot Study Phase 2
Enrolling by invitation NCT02999685 - Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients N/A
Not yet recruiting NCT02892396 - Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD N/A
Recruiting NCT02563184 - Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease Phase 4
Completed NCT02519608 - ComparisoN of ticAgrelor vs. Clopidogrel in endoTHeliAl Function of COPD patieNts Phase 2
Completed NCT02084758 - Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT02694796 - Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy N/A
Completed NCT02750189 - The Economic Burden of Chronic Obstructive Pulmonary Disease(COPD) in South Korea N/A