Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Overview

About this study

The purpose of this open-label study is to evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). 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 and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Participant voluntarily gives informed consent to participate in the study.

2. Participant completed Study RIN-PH-304.

3. 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.

4. 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.

Exclusion Criteria:

1. The participant is pregnant or lactating.

2. The participant was prematurely discontinued from Study RIN-PH-304.

3. The participant is intolerant to inhaled prostanoid therapy.

4. The participant is unwilling or unable to use Sponsor-provided devices (actigraph,
spirometer, or smart device).

5. The participant is scheduled to receive another investigational drug, device, or
therapy during the course of this study.

6. 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator Charles Burger, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Charles Burger, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials