Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

NCT ID: NCT01758744

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-07-31

Brief 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)

Detailed Description

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.

Conditions

Pulmonary Hypertension; COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treprostinil

Inhaled prostanoid therapy with Treprostinil

Group Type: EXPERIMENTAL

Inhaled Treprostinil Therapy

Intervention Type: DRUG

Treprostinil: Inhaled prostanoid therapy

Interventions

Inhaled Treprostinil Therapy

Treprostinil: Inhaled prostanoid therapy

Intervention Type: DRUG

Other Intervention Names

Tyvaso ®

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd M. Bull, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

University of Florida College of Medicine

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

12-0560

Identifier Type: -

Identifier Source: org_study_id