Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Treprostinil

Criteria

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