Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1 (TAPIT-1)

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 1

Conditions: COPD; Pulmonary Hypertension

Treatments: Drug: Inhaled Treprostinil Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01758744

12-0560

Details and patient eligibility

About

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)

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treprostinil

Experimental group

Description:

Inhaled prostanoid therapy with Treprostinil

Treatment:

Drug: Inhaled Treprostinil Therapy