An Open-Label Extension Study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) (PERFECT OLE)

General Information Age Group Adults Status Closed Protocol Number RIN-PH-305 Background Information The purpose of this research study is to assess safety of the study drug and the ability to tolerate long-term treatment with the study drug in patients with PH-COPD. The study will also evaluate the effectiveness of the study drug over long-term treatment. Offered At Inova Fairfax Hospital 3300 Gallows Rd. Falls Church, VA 22042 Principal Investigator Christopher King, MD Eligibility Information Participant voluntarily gives informed consent to participate in the study Participant completed Study RIN-PH-304 Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, [less than 1% per year], such as approved hormonal contraceptives, barrier methods [such as condom or diaphragm] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug Ineligibility Information The participant is pregnant or lactating The participant was prematurely discontinued from Study RIN-PH-304 The participant is intolerant to inhaled prostanoid therapy The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device) The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data More Information: https://clinicaltrials.gov/ct2/show/NCT03794583 Contact Information Contact Name Priscila Dauphin, CCRC Contact Phone 703-776-7128 Contact Email Send Email