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

Overview

Información sobre este estudio

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).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Charles Burger, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20531235

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