Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

University of Colorado, Denver10 enrolled

Overview

An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)

This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension COPD

Interventions

Inhaled Treprostinil TherapyDRUG

Treprostinil: Inhaled prostanoid therapy

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: must have: * be between the ages of 30 and 80 * have a clinical diagnosis of Gold stage 2 to 4 COPD * have a diagnosis of pulmonary hypertension established by a historic right heart catheterization * a minimum weight of 45 Kg * minimum systolic blood pressure of \>90 mmHg * be able to perform a six minute walk test * be able to maintain a oxygen saturation \>88% at rest (with or without oxygen) * be treated with background therapy for COPD for a minimum of 1 month prior to consideration of enrollment. * be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedure. Exclusion Criteria. Cannot have or be: * The presence of pulmonary venous hypertension defined by a historical right heart catheterization * Gold Stage I COPD * documented left ventricular dysfunction as measured by echocardiography * pregnant or breastfeeding * Recipient of a lung transplant * received chronic prostanoid therapy for pulmonary hypertension within 4 weeks prior to the screening appointment * A requirement of greater than 9 l/min of O2 to maintain oxygen saturations greater than 88% at rest * No other serious medical conditions

Locations (2)

University of Colorado Denver

Aurora, Colorado, United States

University of Florida College of Medicine

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).

A 4-Week, Open Label Study Testing the Safety of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Lung Disease (COPD) (PH-COPD)

Time frame: This is a 4 week trial

Secondary Outcomes

New York Heart Association (NYHA) functional class

A change in functional class is assessed as improvement or deterioration in the patient's functional status

Time frame: Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.

Six minute walk distance

A change in how far the subject can walk in 6 minutes will be measured at baseline and compared to how far the subject can walk in 6 minutes at week 4.

Time frame: Change from baseline in 6 minute walk distance at 4 weeks

Clinical Worsening

Clinical worsening is described as Death, hospitalization (all cause)and COPD exacerbations (worsening of respiratory symptoms which require treatment with oral corticosteroids, antibiotics or both).

Time frame: From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks

Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression

The phagocytic index is the average number of bacteria ingested per phagocyte in an incubated mixture of bacteria, phagocytes, and blood serum. We will also be looking a a change in gene expression of these (PBMC) cells. \------------------------------------------------------------------------------

Time frame: Change from baseline in PBMC PI and PBMC gene expression at 4 weeks

Data from ClinicalTrials.gov

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